{"users":[{"id":4,"username":"Naiffer_Host","name":"Naiffer Romero","avatar_template":"/user_avatar/nitrosamines.usp.org/naiffer_host/{size}/3608_2.png","flair_name":"USP_Staff","flair_url":"/uploads/db7259/original/1X/340334bffe0860cc90b26df2ade9e5becac890a9.png","flair_group_id":42,"admin":true,"moderator":true,"trust_level":2},{"id":2474,"username":"drbalamurugank","name":"Dr Balamurugan K","avatar_template":"/user_avatar/nitrosamines.usp.org/drbalamurugank/{size}/1087_2.png","trust_level":2},{"id":4854,"username":"Ana24","name":"Ana Filipa Freire Azedo","avatar_template":"/letter_avatar_proxy/v4/letter/a/6a8cbe/{size}.png","trust_level":1},{"id":146,"username":"jason.brown","name":"Jason Brown","avatar_template":"/user_avatar/nitrosamines.usp.org/jason.brown/{size}/4272_2.png","trust_level":2},{"id":4902,"username":"Phil","name":"","avatar_template":"/letter_avatar_proxy/v4/letter/p/e95f7d/{size}.png","trust_level":2},{"id":133,"username":"Yosukemino","name":"Yosuke Mino","avatar_template":"/user_avatar/nitrosamines.usp.org/yosukemino/{size}/187_2.png","trust_level":2},{"id":8019,"username":"sannadatha","name":"srinivas","avatar_template":"/letter_avatar_proxy/v4/letter/s/5fc32e/{size}.png","trust_level":1},{"id":2485,"username":"mflorea","name":"Mircea Florea","avatar_template":"/letter_avatar_proxy/v4/letter/m/eb9ed0/{size}.png","trust_level":2},{"id":2779,"username":"MarkS","name":"","avatar_template":"/user_avatar/nitrosamines.usp.org/marks/{size}/2220_2.png","trust_level":2},{"id":6673,"username":"RenatS","name":"Renat","avatar_template":"/letter_avatar_proxy/v4/letter/r/53a042/{size}.png","trust_level":2},{"id":7896,"username":"A_nita","name":"Anita","avatar_template":"/letter_avatar_proxy/v4/letter/a/858c86/{size}.png","trust_level":1},{"id":52,"username":"JavierFernandez","name":"","avatar_template":"/letter_avatar_proxy/v4/letter/j/9de053/{size}.png","trust_level":2},{"id":3469,"username":"elenipoliti","name":"Eleni","avatar_template":"/user_avatar/nitrosamines.usp.org/elenipoliti/{size}/3654_2.png","trust_level":2},{"id":8849,"username":"prrmartini","name":"Paulo Martini","avatar_template":"/letter_avatar_proxy/v4/letter/p/c77e96/{size}.png","trust_level":0},{"id":7964,"username":"jueun","name":"Jueun oh","avatar_template":"/letter_avatar_proxy/v4/letter/j/ac91a4/{size}.png","trust_level":1},{"id":4802,"username":"chrischar","name":"christos","avatar_template":"/letter_avatar_proxy/v4/letter/c/c4cdca/{size}.png","trust_level":2},{"id":3470,"username":"Iyappan","name":"Iyappan","avatar_template":"/letter_avatar_proxy/v4/letter/i/bbce88/{size}.png","trust_level":2},{"id":8886,"username":"Ellen16","name":"Yin Thu Eain","avatar_template":"/letter_avatar_proxy/v4/letter/e/bbce88/{size}.png","trust_level":0},{"id":7514,"username":"xainixm","name":"Dr. Siddiqui, Muhammad Zain","avatar_template":"/letter_avatar_proxy/v4/letter/x/8491ac/{size}.png","trust_level":2},{"id":8861,"username":"jagan3862","name":"Jagannath","avatar_template":"/letter_avatar_proxy/v4/letter/j/b5ac83/{size}.png","trust_level":1},{"id":2912,"username":"Koumine","name":"Jack","avatar_template":"/letter_avatar_proxy/v4/letter/k/8c91f0/{size}.png","trust_level":2},{"id":8079,"username":"shuhui.gu","name":"顾书卉","avatar_template":"/letter_avatar_proxy/v4/letter/s/bc8723/{size}.png","trust_level":2},{"id":756,"username":"r.subramaniam","name":"Rama Subramaniam R","avatar_template":"/user_avatar/nitrosamines.usp.org/r.subramaniam/{size}/3557_2.png","primary_group_name":"Japan_Discussion","flair_name":"Japan_Discussion","flair_url":"/uploads/db7259/original/1X/8d5a3e959c0f7a4b42c73c284c5b4a4164b673fc.png","flair_group_id":56,"trust_level":2},{"id":7370,"username":"dinawahba","name":"Dina Wahba","avatar_template":"/letter_avatar_proxy/v4/letter/d/91b2a8/{size}.png","trust_level":1},{"id":6622,"username":"krystynakk","name":"Krystyna Katku","avatar_template":"/letter_avatar_proxy/v4/letter/k/a183cd/{size}.png","trust_level":2},{"id":5702,"username":"Hermine4011","name":"Hermine Takhtalyan","avatar_template":"/user_avatar/nitrosamines.usp.org/hermine4011/{size}/4044_2.png","trust_level":2},{"id":8770,"username":"srinu.deshoju","name":"Deshoju Srinu","avatar_template":"/letter_avatar_proxy/v4/letter/s/838e76/{size}.png","trust_level":0},{"id":7812,"username":"Frida","name":"Frida Agustria","avatar_template":"/letter_avatar_proxy/v4/letter/f/57b2e6/{size}.png","trust_level":1},{"id":3852,"username":"anto","name":"Antonio Rosato","avatar_template":"/letter_avatar_proxy/v4/letter/a/59ef9b/{size}.png","trust_level":1},{"id":7542,"username":"Rajeshramar","name":"RAJESH","avatar_template":"/letter_avatar_proxy/v4/letter/r/7bcc69/{size}.png","trust_level":1},{"id":8507,"username":"Figo","name":"Figo Seelen","avatar_template":"/letter_avatar_proxy/v4/letter/f/e68b1a/{size}.png","trust_level":1},{"id":5917,"username":"daniel.silveira","name":"Daniel Silveira","avatar_template":"/letter_avatar_proxy/v4/letter/d/a6a055/{size}.png","trust_level":2},{"id":6903,"username":"Hasan_T","name":"Hasan Tünel","avatar_template":"/letter_avatar_proxy/v4/letter/h/edb3f5/{size}.png","trust_level":2},{"id":3947,"username":"Gian_Bel","name":"","avatar_template":"/letter_avatar_proxy/v4/letter/g/9fc29f/{size}.png","trust_level":1},{"id":7628,"username":"jingfeng-li","name":"jingfeng-li","avatar_template":"/letter_avatar_proxy/v4/letter/j/278dde/{size}.png","trust_level":1},{"id":5589,"username":"DPandey","name":"Devendra Pandey","avatar_template":"/letter_avatar_proxy/v4/letter/d/779978/{size}.png","trust_level":2},{"id":8149,"username":"swaathi_1997","name":"Swaathi","avatar_template":"/letter_avatar_proxy/v4/letter/s/258eb7/{size}.png","trust_level":1},{"id":8740,"username":"Joakim","name":"Joakim","avatar_template":"/letter_avatar_proxy/v4/letter/j/dec6dc/{size}.png","trust_level":1},{"id":8772,"username":"gokcan","name":"gokcan","avatar_template":"/letter_avatar_proxy/v4/letter/g/57b2e6/{size}.png","trust_level":0},{"id":314,"username":"lucas10mauriz","name":"Lucas Maciel Mauriz Marques ","avatar_template":"/user_avatar/nitrosamines.usp.org/lucas10mauriz/{size}/4075_2.png","trust_level":2},{"id":2480,"username":"Alaaelkazak","name":"Alaa","avatar_template":"/letter_avatar_proxy/v4/letter/a/8491ac/{size}.png","trust_level":2},{"id":45,"username":"DrNagaraju","name":"Dr. Nagaraju Rajana, Scientist at CSIR-IICT in Center for  Mass Spectrometry and Separation Sciences","avatar_template":"/user_avatar/nitrosamines.usp.org/drnagaraju/{size}/3553_2.png","trust_level":2},{"id":8574,"username":"NadeemSal","name":"Nadeem","avatar_template":"/letter_avatar_proxy/v4/letter/n/a5b964/{size}.png","trust_level":1},{"id":6329,"username":"YixuanZhou","name":"Yixuan Zhou","avatar_template":"/letter_avatar_proxy/v4/letter/y/c57346/{size}.png","trust_level":1},{"id":63,"username":"MonazBmysorewala","name":"Monaz ","avatar_template":"/letter_avatar_proxy/v4/letter/m/aca169/{size}.png","trust_level":2},{"id":14,"username":"ASrinivasan","name":"Aloka Srinivasan","avatar_template":"/letter_avatar_proxy/v4/letter/a/b4bc9f/{size}.png","trust_level":2},{"id":7881,"username":"Matilde","name":"Corradi","avatar_template":"/letter_avatar_proxy/v4/letter/m/13edae/{size}.png","trust_level":1},{"id":8134,"username":"Aleyna","name":"Aleyna Karakoç","avatar_template":"/letter_avatar_proxy/v4/letter/a/e47774/{size}.png","trust_level":1},{"id":5967,"username":"DraMarleby","name":"Marleby García","avatar_template":"/letter_avatar_proxy/v4/letter/d/bb73d2/{size}.png","primary_group_name":"Mexico","flair_name":"Mexico","flair_url":"/uploads/db7259/original/2X/8/83440ceb5c2ec33e88bc0ba758db3b666ccc3747.png","flair_group_id":68,"trust_level":2},{"id":8583,"username":"Viralshah","name":"Viral","avatar_template":"/letter_avatar_proxy/v4/letter/v/43a26b/{size}.png","trust_level":0}],"primary_groups":[{"id":56,"name":"Japan_Discussion"},{"id":68,"name":"Mexico"}],"flair_groups":[{"id":42,"name":"USP_Staff","flair_url":"/uploads/db7259/original/1X/340334bffe0860cc90b26df2ade9e5becac890a9.png","flair_bg_color":"","flair_color":""},{"id":56,"name":"Japan_Discussion","flair_url":"/uploads/db7259/original/1X/8d5a3e959c0f7a4b42c73c284c5b4a4164b673fc.png","flair_bg_color":"","flair_color":""},{"id":68,"name":"Mexico","flair_url":"/uploads/db7259/original/2X/8/83440ceb5c2ec33e88bc0ba758db3b666ccc3747.png","flair_bg_color":"","flair_color":""}],"topic_list":{"can_create_topic":false,"more_topics_url":"/c/confirmatory-testing/23?page=1","per_page":30,"top_tags":[{"id":12,"name":"NDSRI","slug":"ndsri"},{"id":6,"name":"Drug_Substance_APIs","slug":"drug-substance-apis"},{"id":2,"name":"Excipients","slug":"excipients"},{"id":23,"name":"risk-assessment","slug":"risk-assessment"},{"id":61,"name":"confirmatory","slug":"confirmatory"},{"id":40,"name":"Nitrite","slug":"nitrite"},{"id":32,"name":"Test-method","slug":"test-method"},{"id":27,"name":"validation","slug":"validation"},{"id":9,"name":"FDA","slug":"fda"},{"id":31,"name":"LCMS","slug":"lcms"},{"id":5,"name":"Packaging","slug":"packaging"},{"id":38,"name":"small-nitrosamines","slug":"small-nitrosamines"},{"id":7,"name":"Solvent_Water","slug":"solvent-water"},{"id":11,"name":"USP-Standards","slug":"usp-standards"}],"topics":[{"fancy_title":"About the Confirmatory Testing category -Please read before posting","fancy_title_localized":false,"locale":null,"id":793,"title":"About the Confirmatory Testing category -Please read before posting","slug":"about-the-confirmatory-testing-category-please-read-before-posting","posts_count":2,"reply_count":0,"highest_post_number":2,"image_url":null,"created_at":"2021-08-13T22:50:58.698Z","last_posted_at":"2025-03-30T03:54:58.623Z","bumped":true,"bumped_at":"2025-03-30T03:54:58.623Z","archetype":"regular","unseen":false,"pinned":true,"unpinned":null,"excerpt":"The development of analytical methodology for potential genotoxic impurities (GTIs) assessment can be time consuming and laborious. While there are several approaches to method development, having a discussion forum to d…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":756,"like_count":1,"has_summary":false,"last_poster_username":"drbalamurugank","category_id":23,"op_like_count":1,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":4,"primary_group_id":null,"flair_group_id":42},{"extras":"latest","description":"Most Recent Poster","user_id":2474,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"In situ Formation and NNNT increase over time","fancy_title_localized":false,"locale":null,"id":15758,"title":"In situ Formation and NNNT increase over time","slug":"in-situ-formation-and-nnnt-increase-over-time","posts_count":7,"reply_count":2,"highest_post_number":7,"image_url":null,"created_at":"2026-09-02T14:43:21.889Z","last_posted_at":"2026-10-07T17:09:42.554Z","bumped":true,"bumped_at":"2026-10-07T17:09:42.554Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Dear group, \nI hope you are all doing well. \nI am currently working on a product containing nortriptyline, and we had developed/validated a quantification method for N-nitroso-nortriptyline (NNNT). \nI would greatly appre…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":12,"name":"NDSRI","slug":"ndsri"},{"id":6,"name":"Drug_Substance_APIs","slug":"drug-substance-apis"}],"tags_descriptions":{},"views":311,"like_count":14,"has_summary":false,"last_poster_username":"Yosukemino","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":4854,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":146,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":4,"primary_group_id":null,"flair_group_id":42},{"extras":null,"description":"Recent Poster","user_id":4902,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":133,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"How to overcome blank interference at NDBA","fancy_title_localized":false,"locale":null,"id":15389,"title":"How to overcome blank interference at NDBA","slug":"how-to-overcome-blank-interference-at-ndba","posts_count":9,"reply_count":2,"highest_post_number":9,"image_url":null,"created_at":"2026-04-22T23:50:10.336Z","last_posted_at":"2026-10-03T18:50:32.029Z","bumped":true,"bumped_at":"2026-10-03T18:50:32.029Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"I am consistently observing blank interference at the NDBA retention time while analyzing small nitrosamines using LC-MS/MS. Currently, I am applying blank correction as a temporary measure. \nHow can I systematically tro…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":61,"name":"confirmatory","slug":"confirmatory"}],"tags_descriptions":{},"views":369,"like_count":18,"has_summary":false,"last_poster_username":"RenatS","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":8019,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":2485,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":2779,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":146,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":6673,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Confirmatory testing - on how many batches?","fancy_title_localized":false,"locale":null,"id":15818,"title":"Confirmatory testing - on how many batches?","slug":"confirmatory-testing-on-how-many-batches","posts_count":7,"reply_count":4,"highest_post_number":7,"image_url":null,"created_at":"2026-09-30T15:20:31.874Z","last_posted_at":"2026-10-02T11:56:40.857Z","bumped":true,"bumped_at":"2026-10-02T11:56:40.857Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Dear Community, \nI have a question regarding the expectations for nitrosamine confirmatory testing following a recent LoD from the authorities. \nWe applied for skip testing based on consistently low nitrosamine results (…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":308,"like_count":10,"has_summary":false,"last_poster_username":"jason.brown","category_id":23,"op_like_count":1,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":7896,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":52,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":3469,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":146,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Qualitative & Quantitative Analysis of Nitrosamines by FTIR","fancy_title_localized":false,"locale":null,"id":15677,"title":"Qualitative & Quantitative Analysis of Nitrosamines by FTIR","slug":"qualitative-quantitative-analysis-of-nitrosamines-by-ftir","posts_count":9,"reply_count":5,"highest_post_number":9,"image_url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/2/2e842ae1040680d19c1285663421848bf7c9d92e_2_1024x369.png","created_at":"2026-08-03T08:25:38.312Z","last_posted_at":"2026-09-28T21:18:25.101Z","bumped":true,"bumped_at":"2026-09-28T21:18:25.101Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"An interesting paper that looks to be worthy of further investigation. \nWhether it would work in a drug product matrix? \nDoes it work for NDSRIs? \nCan it be made sensitive enough to remove the need for mass-spec testing …","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":[{"max_width":null,"max_height":null,"width":1031,"height":372,"url":"https://nitrosamines.usp.org/uploads/db7259/original/2X/2/2e842ae1040680d19c1285663421848bf7c9d92e.png"},{"max_width":1024,"max_height":1024,"width":1024,"height":369,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/2/2e842ae1040680d19c1285663421848bf7c9d92e_2_1024x369.png"},{"max_width":750,"max_height":750,"width":750,"height":270,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/2/2e842ae1040680d19c1285663421848bf7c9d92e_2_750x270.png"},{"max_width":500,"max_height":500,"width":500,"height":180,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/2/2e842ae1040680d19c1285663421848bf7c9d92e_2_500x180.png"},{"max_width":375,"max_height":375,"width":375,"height":135,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/2/2e842ae1040680d19c1285663421848bf7c9d92e_2_375x135.png"}],"tags":[],"tags_descriptions":{},"views":404,"like_count":13,"has_summary":false,"last_poster_username":"prrmartini","category_id":23,"op_like_count":1,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":2779,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":52,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":2485,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":4,"primary_group_id":null,"flair_group_id":42},{"extras":"latest","description":"Most Recent Poster","user_id":8849,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Issue Regarding Purchase of N-Nitroso N-Desmethyl Rosuvastatin Reference Standard","fancy_title_localized":false,"locale":null,"id":14797,"title":"Issue Regarding Purchase of N-Nitroso N-Desmethyl Rosuvastatin Reference Standard","slug":"issue-regarding-purchase-of-n-nitroso-n-desmethyl-rosuvastatin-reference-standard","posts_count":13,"reply_count":8,"highest_post_number":13,"image_url":null,"created_at":"2025-12-09T06:25:43.019Z","last_posted_at":"2026-09-26T08:10:22.422Z","bumped":true,"bumped_at":"2026-09-26T08:10:22.422Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"1. Could anyone share where I can obtain or purchase the reference standard for N-Nitroso N-Desmethyl Rosuvastatin? \n2. I was told that synthesizing N-Nitroso N-Desmethyl Rosuvastatin is difficult and the request was dec…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":12,"name":"NDSRI","slug":"ndsri"}],"tags_descriptions":{},"views":518,"like_count":13,"has_summary":false,"last_poster_username":"Ellen16","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":7964,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":4802,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":52,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":3470,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":8886,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Is Sensitivity really the biggest challenge or is it sample preparation?","fancy_title_localized":false,"locale":null,"id":15750,"title":"Is Sensitivity really the biggest challenge or is it sample preparation?","slug":"is-sensitivity-really-the-biggest-challenge-or-is-it-sample-preparation","posts_count":2,"reply_count":0,"highest_post_number":2,"image_url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/7/7d337194776c90ea8fc550434869c4d096341f96_2_724x1024.jpeg","created_at":"2026-08-31T14:14:11.036Z","last_posted_at":"2026-09-24T10:09:41.136Z","bumped":true,"bumped_at":"2026-09-24T10:09:41.136Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"NDSRI Analysis: Is Sensitivity Really the Biggest Challenge—or Is It Sample Preparation?\nAn interesting 2026 paper in BMC Chemistry reports an LC–TQ–MS/MS method for trace-level determination of two levofloxacin-associ…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":[{"max_width":null,"max_height":null,"width":827,"height":1169,"url":"https://nitrosamines.usp.org/uploads/db7259/original/2X/7/7d337194776c90ea8fc550434869c4d096341f96.jpeg"},{"max_width":1024,"max_height":1024,"width":724,"height":1024,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/7/7d337194776c90ea8fc550434869c4d096341f96_2_724x1024.jpeg"},{"max_width":750,"max_height":750,"width":530,"height":750,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/7/7d337194776c90ea8fc550434869c4d096341f96_2_530x750.jpeg"},{"max_width":500,"max_height":500,"width":353,"height":500,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/7/7d337194776c90ea8fc550434869c4d096341f96_2_353x500.jpeg"},{"max_width":375,"max_height":375,"width":265,"height":375,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/7/7d337194776c90ea8fc550434869c4d096341f96_2_265x375.jpeg"}],"tags":[{"id":12,"name":"NDSRI","slug":"ndsri"}],"tags_descriptions":{},"views":196,"like_count":6,"has_summary":false,"last_poster_username":"Phil","category_id":23,"op_like_count":2,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":7514,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":4902,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Nitrosamine Analytical Method Development","fancy_title_localized":false,"locale":null,"id":15786,"title":"Nitrosamine Analytical Method Development","slug":"nitrosamine-analytical-method-development","posts_count":5,"reply_count":1,"highest_post_number":5,"image_url":null,"created_at":"2026-09-15T08:27:45.847Z","last_posted_at":"2026-09-18T04:29:39.203Z","bumped":true,"bumped_at":"2026-09-18T04:29:39.203Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Hi, Probable Nitrosamine that can form in my drug product is NDMA which has an AI of 96 ng/day & my drug product Maximum daily dose is 7.5 g/day, the derived spec for the said Nitrosamine is 12.8 ng/g. Then why developin…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":293,"like_count":14,"has_summary":false,"last_poster_username":"jagan3862","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":"latest","description":"Original Poster, Most Recent Poster","user_id":8861,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":4,"primary_group_id":null,"flair_group_id":42},{"extras":null,"description":"Recent Poster","user_id":2912,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"EDTA-Related Nitrosamine Impurities: Two Critical Pain Points in Pharma R&D","fancy_title_localized":false,"locale":null,"id":15493,"title":"EDTA-Related Nitrosamine Impurities: Two Critical Pain Points in Pharma R&D","slug":"edta-related-nitrosamine-impurities-two-critical-pain-points-in-pharma-r-d","posts_count":9,"reply_count":2,"highest_post_number":9,"image_url":null,"created_at":"2026-05-28T10:39:58.160Z","last_posted_at":"2026-09-07T20:38:43.985Z","bumped":true,"bumped_at":"2026-09-07T20:38:43.985Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"EDTA (ethylenediaminetetraacetic acid) is a classic chelating excipient widely used in ophthalmic solutions, injections, and contrast agents. It stabilizes formulations by efficiently binding metal ions (Ca²⁺, Mg²⁺, Fe³⁺…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":12,"name":"NDSRI","slug":"ndsri"}],"tags_descriptions":{},"views":789,"like_count":14,"has_summary":false,"last_poster_username":"krystynakk","category_id":23,"op_like_count":2,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":8079,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":756,"primary_group_id":56,"flair_group_id":56},{"extras":null,"description":"Frequent Poster","user_id":146,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":7370,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":6622,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"A Derivatization Free HPLC–UV Method for Nitrite Quantification in Strongly Matrix-Affected Pharmaceutical Excipients-Pub「","fancy_title_localized":false,"locale":null,"id":15762,"title":"A Derivatization Free HPLC–UV Method for Nitrite Quantification in Strongly Matrix-Affected Pharmaceutical Excipients-Pub「","slug":"a-derivatization-free-hplc-uv-method-for-nitrite-quantification-in-strongly-matrix-affected-pharmaceutical-excipients-pub","posts_count":4,"reply_count":1,"highest_post_number":4,"image_url":null,"created_at":"2026-09-03T16:59:15.754Z","last_posted_at":"2026-09-05T10:41:56.206Z","bumped":true,"bumped_at":"2026-09-05T10:41:56.206Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/sscp.70300 \nABSTRACT\nThe assessment of nitrosamine risk in pharmaceuticals is an issue for ensuring the safety and efficacy of medicinal products. In …","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":2,"name":"Excipients","slug":"excipients"}],"tags_descriptions":{},"views":266,"like_count":6,"has_summary":false,"last_poster_username":"Hermine4011","category_id":23,"op_like_count":4,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":133,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":5702,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"N-Nitroso Nilotinib","fancy_title_localized":false,"locale":null,"id":15755,"title":"N-Nitroso Nilotinib","slug":"n-nitroso-nilotinib","posts_count":1,"reply_count":0,"highest_post_number":1,"image_url":null,"created_at":"2026-09-02T08:59:32.591Z","last_posted_at":"2026-09-02T08:59:32.760Z","bumped":true,"bumped_at":"2026-09-02T08:59:32.760Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Is there any specific reference method for N-Nitroso Nilotinib in Nilotinib HCl Mono/Di hyadrate or tartrate.","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":122,"like_count":1,"has_summary":false,"last_poster_username":"srinu.deshoju","category_id":23,"op_like_count":1,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":"latest single","description":"Original Poster, Most Recent Poster","user_id":8770,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Establishing a Robust High Performance Liquid Chromatography−Ultraviolet Detection Technique for Nitrite Quantification in Pharmaceutical Excipients and Active Pharmaceutical Ingredients-Pub","fancy_title_localized":false,"locale":null,"id":15736,"title":"Establishing a Robust High Performance Liquid Chromatography−Ultraviolet Detection Technique for Nitrite Quantification in Pharmaceutical Excipients and Active Pharmaceutical Ingredients-Pub","slug":"establishing-a-robust-high-performance-liquid-chromatography-ultraviolet-detection-technique-for-nitrite-quantification-in-pharmaceutical-excipients-and-active-pharmaceutical-ingredients-pub","posts_count":1,"reply_count":0,"highest_post_number":1,"image_url":null,"created_at":"2026-08-22T19:53:10.126Z","last_posted_at":"2026-08-22T19:53:10.398Z","bumped":true,"bumped_at":"2026-08-22T19:53:10.398Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/jssc.70512 \nABSTRACT\nNitrite impurities are frequently present in pharmaceutical excipients as a result of raw material sources and manufacturing proc…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":2,"name":"Excipients","slug":"excipients"}],"tags_descriptions":{},"views":145,"like_count":2,"has_summary":false,"last_poster_username":"Yosukemino","category_id":23,"op_like_count":2,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":"latest single","description":"Original Poster, Most Recent Poster","user_id":133,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"A Rapid and Sensitive LC–MS/MS Method for Quantification of NDSRI in Melatonin Drug Product via Controlled In Situ Formation-Pub","fancy_title_localized":false,"locale":null,"id":15713,"title":"A Rapid and Sensitive LC–MS/MS Method for Quantification of NDSRI in Melatonin Drug Product via Controlled In Situ Formation-Pub","slug":"a-rapid-and-sensitive-lc-ms-ms-method-for-quantification-of-ndsri-in-melatonin-drug-product-via-controlled-in-situ-formation-pub","posts_count":1,"reply_count":0,"highest_post_number":1,"image_url":null,"created_at":"2026-08-14T13:25:39.905Z","last_posted_at":"2026-08-14T13:25:40.075Z","bumped":true,"bumped_at":"2026-08-14T13:25:40.075Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"3,4-diaminotoluene solution was used as a scavenger for nitrites to prevent false positives. \nhttps://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/bmc.70591 \nABSTRACT\nNitrosamine drug substance–related i…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":12,"name":"NDSRI","slug":"ndsri"}],"tags_descriptions":{},"views":141,"like_count":2,"has_summary":false,"last_poster_username":"Yosukemino","category_id":23,"op_like_count":2,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":"latest single","description":"Original Poster, Most Recent Poster","user_id":133,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"N-Nitroso Metamizole Impurity C","fancy_title_localized":false,"locale":null,"id":15152,"title":"N-Nitroso Metamizole Impurity C","slug":"n-nitroso-metamizole-impurity-c","posts_count":6,"reply_count":1,"highest_post_number":6,"image_url":null,"created_at":"2026-02-18T03:22:29.126Z","last_posted_at":"2026-08-11T08:13:08.138Z","bumped":true,"bumped_at":"2026-08-11T08:13:08.138Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Hello everyone, \nI had being develop a method of N-nitroso Metamizole Impurity C using LC-MS. And have some issue as below : \n\nN-Nitroso Metamizole Impurity C peak is appears in diluent chromatogram (even tried to minimi…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":12,"name":"NDSRI","slug":"ndsri"}],"tags_descriptions":{},"views":578,"like_count":1,"has_summary":false,"last_poster_username":"Frida","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":"latest","description":"Original Poster, Most Recent Poster","user_id":7812,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":4902,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":3852,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":8079,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"An Analytical Quality by Design-guided method development for the quantification of N-nitroso-fluoxetine to support mitigation strategies for a fluoxetine drug product-Pub","fancy_title_localized":false,"locale":null,"id":15690,"title":"An Analytical Quality by Design-guided method development for the quantification of N-nitroso-fluoxetine to support mitigation strategies for a fluoxetine drug product-Pub","slug":"an-analytical-quality-by-design-guided-method-development-for-the-quantification-of-n-nitroso-fluoxetine-to-support-mitigation-strategies-for-a-fluoxetine-drug-product-pub","posts_count":3,"reply_count":1,"highest_post_number":3,"image_url":null,"created_at":"2026-08-05T22:20:41.700Z","last_posted_at":"2026-08-08T21:11:07.394Z","bumped":true,"bumped_at":"2026-08-08T21:11:07.394Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"https://www.sciencedirect.com/science/article/abs/pii/S0731708526003602 \nAbstract\nThis work focused on N-nitroso-fluoxetine, a N-nitrosamine drug substance-related impurity (NDSRI) formed in fluoxetine-containing product…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":12,"name":"NDSRI","slug":"ndsri"}],"tags_descriptions":{},"views":273,"like_count":8,"has_summary":false,"last_poster_username":"Yosukemino","category_id":23,"op_like_count":3,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":"latest","description":"Original Poster, Most Recent Poster","user_id":133,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":4802,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"N Nitroso Tadalfil","fancy_title_localized":false,"locale":null,"id":14307,"title":"N Nitroso Tadalfil","slug":"n-nitroso-tadalfil","posts_count":20,"reply_count":14,"highest_post_number":20,"image_url":null,"created_at":"2025-09-17T17:50:03.139Z","last_posted_at":"2026-08-07T12:24:57.290Z","bumped":true,"bumped_at":"2026-08-07T12:24:57.290Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Hello all, \nI am developing an LC–MS/MS method for N-nitroso tadalafil. Based on structure, I expected the [M+H]⁺ precursor around m/z 419, but in my scan I am seeing a strong signal at m/z 389. \nHas anyone else observed…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":1524,"like_count":22,"has_summary":false,"last_poster_username":"Hasan_T","category_id":23,"op_like_count":3,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":7542,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":8507,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":8079,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":5917,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":6903,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Nitrosamine Control Strategy for Products within the Scope of ICH S9","fancy_title_localized":false,"locale":null,"id":15675,"title":"Nitrosamine Control Strategy for Products within the Scope of ICH S9","slug":"nitrosamine-control-strategy-for-products-within-the-scope-of-ich-s9","posts_count":6,"reply_count":2,"highest_post_number":6,"image_url":null,"created_at":"2026-08-03T05:28:40.893Z","last_posted_at":"2026-08-07T07:40:22.683Z","bumped":true,"bumped_at":"2026-08-07T07:40:22.683Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"An assessment is required regarding the appropriate nitrosamine control strategy for products falling within the scope of ICH S9. According to the relevant guideline, nitrosamines should be evaluated in accordance with I…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":12,"name":"NDSRI","slug":"ndsri"},{"id":23,"name":"risk-assessment","slug":"risk-assessment"}],"tags_descriptions":{},"views":367,"like_count":11,"has_summary":false,"last_poster_username":"chrischar","category_id":23,"op_like_count":1,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":6903,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":2485,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":52,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":3947,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":4802,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Determination of Trace Nitrosamines in Plastic Pharmaceutical Packaging Materials","fancy_title_localized":false,"locale":null,"id":15685,"title":"Determination of Trace Nitrosamines in Plastic Pharmaceutical Packaging Materials","slug":"determination-of-trace-nitrosamines-in-plastic-pharmaceutical-packaging-materials","posts_count":3,"reply_count":1,"highest_post_number":3,"image_url":null,"created_at":"2026-08-04T08:02:12.347Z","last_posted_at":"2026-08-04T20:04:49.534Z","bumped":true,"bumped_at":"2026-08-04T20:04:49.534Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Could any teacher provide the PDF version of this literature?","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":210,"like_count":1,"has_summary":false,"last_poster_username":"jason.brown","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":7628,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":2485,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":146,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"N-Nitroso meglumine","fancy_title_localized":false,"locale":null,"id":12131,"title":"N-Nitroso meglumine","slug":"n-nitroso-meglumine","posts_count":35,"reply_count":30,"highest_post_number":38,"image_url":null,"created_at":"2024-12-18T11:43:24.430Z","last_posted_at":"2026-08-01T01:37:22.783Z","bumped":true,"bumped_at":"2026-08-01T01:37:22.783Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Struggling to develop the method of NDSRI N-Nitroso meglumine in Telmisartan Tablets. Impurity shows very notorious behavior. Any one having methods or feed back in regards please let me know.","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":3134,"like_count":13,"has_summary":false,"last_poster_username":"Koumine","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":5589,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":8149,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":8740,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":8772,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":2912,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"N-Nitroso Desmethyl Tramadol - Standard","fancy_title_localized":false,"locale":null,"id":15627,"title":"N-Nitroso Desmethyl Tramadol - Standard","slug":"n-nitroso-desmethyl-tramadol-standard","posts_count":4,"reply_count":0,"highest_post_number":4,"image_url":null,"created_at":"2026-07-22T14:26:04.970Z","last_posted_at":"2026-07-27T17:19:18.756Z","bumped":true,"bumped_at":"2026-07-27T17:19:18.756Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Hello, \nI have a situation regarding the N-Nitroso Desmethyl Tramadol. The EMA appendix describe this nitrosamine as “N-[[(1R,2R)-2-hydroxy-2-(3-methoxyphenyl)cyclohexyl]methyl]-N-methylnitrous amide”, so from this point…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":12,"name":"NDSRI","slug":"ndsri"}],"tags_descriptions":{},"views":287,"like_count":13,"has_summary":false,"last_poster_username":"lucas10mauriz","category_id":23,"op_like_count":1,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":5917,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":314,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Nitrosamines: Mass Spectrometry-Based Analytical Procedures Criterias","fancy_title_localized":false,"locale":null,"id":7394,"title":"Nitrosamines: Mass Spectrometry-Based Analytical Procedures Criterias","slug":"nitrosamines-mass-spectrometry-based-analytical-procedures-criterias","posts_count":13,"reply_count":10,"highest_post_number":13,"image_url":"https://nitrosamines.usp.org/uploads/db7259/original/2X/3/318cf5e1f87d350d7a007202992d7bf399d1ea41.png","created_at":"2023-08-23T14:40:31.109Z","last_posted_at":"2026-07-25T12:21:34.964Z","bumped":true,"bumped_at":"2026-07-25T12:21:34.964Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Are you facing significant challenges in your analytical methodology for quantifying nitrosamines? \nA collaborative effort involving various regulatory bodies occurred, including: US FDA, Health Canada, ANSM (France), Sw…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":[{"max_width":null,"max_height":null,"width":918,"height":553,"url":"https://nitrosamines.usp.org/uploads/db7259/original/2X/3/318cf5e1f87d350d7a007202992d7bf399d1ea41.png"},{"max_width":750,"max_height":750,"width":750,"height":451,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/3/318cf5e1f87d350d7a007202992d7bf399d1ea41_2_750x451.png"},{"max_width":500,"max_height":500,"width":500,"height":301,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/3/318cf5e1f87d350d7a007202992d7bf399d1ea41_2_500x301.png"},{"max_width":375,"max_height":375,"width":375,"height":225,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/3/318cf5e1f87d350d7a007202992d7bf399d1ea41_2_375x225.png"}],"tags":[{"id":9,"name":"FDA","slug":"fda"},{"id":61,"name":"confirmatory","slug":"confirmatory"},{"id":27,"name":"validation","slug":"validation"}],"tags_descriptions":{},"views":4757,"like_count":31,"has_summary":false,"last_poster_username":"NadeemSal","category_id":23,"op_like_count":7,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":314,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":4,"primary_group_id":null,"flair_group_id":42},{"extras":null,"description":"Frequent Poster","user_id":2480,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":45,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":8574,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"N-nitrosoproline","fancy_title_localized":false,"locale":null,"id":15617,"title":"N-nitrosoproline","slug":"n-nitrosoproline","posts_count":1,"reply_count":0,"highest_post_number":1,"image_url":null,"created_at":"2026-07-20T07:29:56.553Z","last_posted_at":"2026-07-20T07:29:56.643Z","bumped":true,"bumped_at":"2026-07-20T07:29:56.643Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"How to detect N-nitrosoproline in multi-amino acid systems？For the Compound Amino Acids Ihjection.Additionally, the N-nitrosotryptophan we obtained has a purity of only 45%（based on qNMR）; can it be used for analytical m…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":124,"like_count":0,"has_summary":false,"last_poster_username":"YixuanZhou","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":"latest single","description":"Original Poster, Most Recent Poster","user_id":6329,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Determining Low PPB Levels of Nitrite in Polymeric Excipients","fancy_title_localized":false,"locale":null,"id":11250,"title":"Determining Low PPB Levels of Nitrite in Polymeric Excipients","slug":"determining-low-ppb-levels-of-nitrite-in-polymeric-excipients","posts_count":3,"reply_count":1,"highest_post_number":3,"image_url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/1/1afcc2080e3888ec3b93337b8ad8a60a4a390c2f_2_1024x576.jpeg","created_at":"2024-09-10T19:06:59.871Z","last_posted_at":"2026-07-19T10:45:30.335Z","bumped":true,"bumped_at":"2026-07-19T10:45:30.335Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Abstract\nIn this paper, the authors introduce a method that combines ion exchange chromatography with a easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophoto…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":[{"max_width":null,"max_height":null,"width":1280,"height":720,"url":"https://nitrosamines.usp.org/uploads/db7259/original/2X/1/1afcc2080e3888ec3b93337b8ad8a60a4a390c2f.jpeg"},{"max_width":1024,"max_height":1024,"width":1024,"height":576,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/1/1afcc2080e3888ec3b93337b8ad8a60a4a390c2f_2_1024x576.jpeg"},{"max_width":750,"max_height":750,"width":750,"height":421,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/1/1afcc2080e3888ec3b93337b8ad8a60a4a390c2f_2_750x421.jpeg"},{"max_width":500,"max_height":500,"width":500,"height":281,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/1/1afcc2080e3888ec3b93337b8ad8a60a4a390c2f_2_500x281.jpeg"},{"max_width":375,"max_height":375,"width":375,"height":210,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/1/1afcc2080e3888ec3b93337b8ad8a60a4a390c2f_2_375x210.jpeg"}],"tags":[{"id":2,"name":"Excipients","slug":"excipients"}],"tags_descriptions":{},"views":429,"like_count":7,"has_summary":false,"last_poster_username":"jason.brown","category_id":23,"op_like_count":3,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":133,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":5702,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":146,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"Trace-level LC–MS/MS quantification of two nitrosamine impurities formed from terazosin-related impurities in pharmaceutical products and greenness assessment-Pub","fancy_title_localized":false,"locale":null,"id":15602,"title":"Trace-level LC–MS/MS quantification of two nitrosamine impurities formed from terazosin-related impurities in pharmaceutical products and greenness assessment-Pub","slug":"trace-level-lc-ms-ms-quantification-of-two-nitrosamine-impurities-formed-from-terazosin-related-impurities-in-pharmaceutical-products-and-greenness-assessment-pub","posts_count":3,"reply_count":0,"highest_post_number":3,"image_url":null,"created_at":"2026-07-13T16:11:17.870Z","last_posted_at":"2026-07-15T15:04:08.279Z","bumped":true,"bumped_at":"2026-07-15T15:04:08.279Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Abstract\nRecently, the focus of regulatory agencies has shifted to nitrosamine drug substance-related impurities (NDSRIs). Terazosin has two secondary amine impurities, impurity C and impurity N, that are potential precu…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[{"id":12,"name":"NDSRI","slug":"ndsri"}],"tags_descriptions":{},"views":225,"like_count":6,"has_summary":false,"last_poster_username":"ASrinivasan","category_id":23,"op_like_count":4,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":133,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":63,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":14,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"N-nitroso-Furosemide","fancy_title_localized":false,"locale":null,"id":14818,"title":"N-nitroso-Furosemide","slug":"n-nitroso-furosemide","posts_count":5,"reply_count":1,"highest_post_number":7,"image_url":null,"created_at":"2025-12-11T15:48:48.350Z","last_posted_at":"2026-07-06T07:54:05.283Z","bumped":true,"bumped_at":"2026-07-06T07:54:05.283Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Hi everyone, \nThe laboratory we commissioned the development of a method for determining N-nitroso-furosemide content in a Drug Product is encountering many difficulties and, even now, after more than a year of work, has…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":798,"like_count":6,"has_summary":false,"last_poster_username":"Phil","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":7881,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Frequent Poster","user_id":133,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":8134,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":4902,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"N-Nitroso Desethyl Amiodarone in Amiodarone HCl Tablets by LC-MS/MS Metodu","fancy_title_localized":false,"locale":null,"id":15427,"title":"N-Nitroso Desethyl Amiodarone in Amiodarone HCl Tablets by LC-MS/MS Metodu","slug":"n-nitroso-desethyl-amiodarone-in-amiodarone-hcl-tablets-by-lc-ms-ms-metodu","posts_count":6,"reply_count":3,"highest_post_number":6,"image_url":null,"created_at":"2026-05-08T12:08:42.387Z","last_posted_at":"2026-07-06T05:44:16.273Z","bumped":true,"bumped_at":"2026-07-06T05:44:16.273Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"N-Nitroso Desethyl Amiodarone için metot geliştirme çalışması yapmaya çalışıyorum. Limiti çok düşük olduğu için numuneye spike yaptığımı geri kazanım alamıyorum. Birçok kolon, mobil faz ve solvent denedim. Aynı sorunu ya…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":321,"like_count":2,"has_summary":false,"last_poster_username":"Phil","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":8134,"primary_group_id":null,"flair_group_id":null},{"extras":null,"description":"Recent Poster","user_id":8079,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":4902,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"NDBA interference on Parecoxib testing?","fancy_title_localized":false,"locale":null,"id":15544,"title":"NDBA interference on Parecoxib testing?","slug":"ndba-interference-on-parecoxib-testing","posts_count":4,"reply_count":0,"highest_post_number":4,"image_url":null,"created_at":"2026-06-15T18:59:26.813Z","last_posted_at":"2026-06-23T12:54:23.054Z","bumped":true,"bumped_at":"2026-06-23T12:54:23.054Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Hola grupo! \nTienen alguna referencia de un método para cuantificar NDBA en Parecoxib 40 mg? \nHe presentado interferencias con el método FDA. \nGracias!","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":182,"like_count":0,"has_summary":false,"last_poster_username":"Phil","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":5967,"primary_group_id":68,"flair_group_id":68},{"extras":null,"description":"Recent Poster","user_id":4,"primary_group_id":null,"flair_group_id":42},{"extras":"latest","description":"Most Recent Poster","user_id":4902,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"A Robust and Universal LC–MS/MS Method for Determination of N-Nitrosodimethylamine in Pharmaceuticals Using a C30 Column -Pub","fancy_title_localized":false,"locale":null,"id":15563,"title":"A Robust and Universal LC–MS/MS Method for Determination of N-Nitrosodimethylamine in Pharmaceuticals Using a C30 Column -Pub","slug":"a-robust-and-universal-lc-ms-ms-method-for-determination-of-n-nitrosodimethylamine-in-pharmaceuticals-using-a-c30-column-pub","posts_count":2,"reply_count":0,"highest_post_number":2,"image_url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/b/b77549ee69c0ced687cbb557845ced99bc4eccad_2_1024x523.jpeg","created_at":"2026-06-22T15:59:55.528Z","last_posted_at":"2026-06-22T16:00:36.459Z","bumped":true,"bumped_at":"2026-06-22T16:00:36.459Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"A Robust and Universal LC–MS/MS Method for Determination of N-Nitrosodimethylamine in Pharmaceuticals Using a C30 Column \n\nAbstract: \nSince the 2018 valsartan recall, the genotoxic impurity N- nitrosodimethylamine (NDMA)…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":[{"max_width":null,"max_height":null,"width":1200,"height":614,"url":"https://nitrosamines.usp.org/uploads/db7259/original/2X/b/b77549ee69c0ced687cbb557845ced99bc4eccad.jpeg"},{"max_width":1024,"max_height":1024,"width":1024,"height":523,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/b/b77549ee69c0ced687cbb557845ced99bc4eccad_2_1024x523.jpeg"},{"max_width":750,"max_height":750,"width":750,"height":383,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/b/b77549ee69c0ced687cbb557845ced99bc4eccad_2_750x383.jpeg"},{"max_width":500,"max_height":500,"width":500,"height":255,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/b/b77549ee69c0ced687cbb557845ced99bc4eccad_2_500x255.jpeg"},{"max_width":375,"max_height":375,"width":375,"height":191,"url":"https://nitrosamines.usp.org/uploads/db7259/optimized/2X/b/b77549ee69c0ced687cbb557845ced99bc4eccad_2_375x191.jpeg"}],"tags":[],"tags_descriptions":{},"views":229,"like_count":8,"has_summary":false,"last_poster_username":"Naiffer_Host","category_id":23,"op_like_count":4,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":"latest single","description":"Original Poster, Most Recent Poster","user_id":4,"primary_group_id":null,"flair_group_id":42}]},{"fancy_title":"N-Nitroso Vonoprazan impurity peak area variation observed during drug product analysis by LCMS","fancy_title_localized":false,"locale":null,"id":15515,"title":"N-Nitroso Vonoprazan impurity peak area variation observed during drug product analysis by LCMS","slug":"n-nitroso-vonoprazan-impurity-peak-area-variation-observed-during-drug-product-analysis-by-lcms","posts_count":2,"reply_count":0,"highest_post_number":2,"image_url":null,"created_at":"2026-06-08T06:36:27.541Z","last_posted_at":"2026-06-08T10:58:35.555Z","bumped":true,"bumped_at":"2026-06-08T10:58:35.555Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"N-Nitroso Vonoprazan impurity peak area variation observed during drug product sample analysis by LCMS. Anyone facing same problem during the sample analysis? The initial standard solution gives stable response (%C.V. of…","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":178,"like_count":0,"has_summary":false,"last_poster_username":"Phil","category_id":23,"op_like_count":0,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":8583,"primary_group_id":null,"flair_group_id":null},{"extras":"latest","description":"Most Recent Poster","user_id":4902,"primary_group_id":null,"flair_group_id":null}]},{"fancy_title":"MS Method Development Criterias?","fancy_title_localized":false,"locale":null,"id":15502,"title":"MS Method Development Criterias?","slug":"ms-method-development-criterias","posts_count":2,"reply_count":0,"highest_post_number":2,"image_url":null,"created_at":"2026-06-01T18:06:03.403Z","last_posted_at":"2026-06-02T14:21:32.263Z","bumped":true,"bumped_at":"2026-06-02T14:21:32.263Z","archetype":"regular","unseen":false,"pinned":false,"unpinned":null,"excerpt":"Posting in behalf of one of our community members! \n\nWe are currently working on a product containing nortriptyline, and we are in the process of developing/validating a quantification method for N-nitroso-nortriptyline …","visible":true,"closed":false,"archived":false,"bookmarked":null,"liked":null,"thumbnails":null,"tags":[],"tags_descriptions":{},"views":207,"like_count":5,"has_summary":false,"last_poster_username":"jason.brown","category_id":23,"op_like_count":1,"pinned_globally":false,"featured_link":null,"has_accepted_answer":false,"can_vote":false,"posters":[{"extras":null,"description":"Original Poster","user_id":4,"primary_group_id":null,"flair_group_id":42},{"extras":"latest","description":"Most Recent Poster","user_id":146,"primary_group_id":null,"flair_group_id":null}]}]}}