Dear all,
my name is Christos and i am from Greece.
I am working for more than 20 years in Pharmaceutical industry, initially in the synthesis of new active molecules and later on in the analytical development of RnD dpt.
The last two years i am running, among other things, the risk assessment reports of our company along with an external expert, mainly due to my origin in Organic chemistry, where my Ph.D. have been done.
Is a great pleasure for me to discover this very interesting group and i would like to thank you a lot for the acceptance.
Kind regards
Christos
Hello team. My name is Daniel John. I am a pharmacist and I’m now working as an external expert for Tanzania Medicines and Medical Devices Authority. I am particularly enthusiastic about nitrosamines and will learn a lot from you all. Of course I’ll also be sharing on here something about this pandemic in a pharmaceutical regulatory affairs world.
Hi Everyone,
I am Nainesh working in quality and regulatory department of Syngene, India. This is a CRAM business and I am looking for the recent developments and validation requirements of Geno and Nitrosamines. We want to keep ourselves abreast with the industry and regulatory requirements. Looking forward interacting with you all.
Hello Nitrosamines Exchange Community,
I’m Srinivas Birudukota, Sr. Manager in QC and ADL at Trroy Life Sciences Pvt Ltd, specializing in LCMS/MS method development for Genotoxic impurities. My interest extends to global perspectives on N-Nitrosamines. Eager to contribute and collaborate within the community.
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Hello, I am Werner and working as a Scientist a Johnson & Johnson and specialized in analytics. Through the past years I rolled in in the Nitrosamines, specially for the analytical part. I already developed analytical methods for Small Nitroso compounds (NDMA) and NDSRIs. Due to matrix and acceptance limit (or more 10% of the acceptance limit) analytical approach is sometimes challenging. My worst concern is creating false positives, due to the batch variabilities which is not picked up during method development.
Helllo All , My Name is Viraj parmar, currently working at Amoli Organics. I am working in analytical development laboratory. Performing analytical method development and method validation activities for General Nitrosamines and NDSRI in Drug substances and drug products. Based on CPCA calculations & MDD , we work on limits to perform risk assessment Study or to be entitled in spec. Proposal for the Routine batch screenings in Drug substances and Drug products. Using LC-MS/MS & GC-MS/MS methodology we can easily quantitate Nitrosamines to the PPB to PPT levels as well.
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Hello everyone,
I am already a member of this wothy community for 3 months now. So it is time to introduce myself:
My name is Heike Graf and I am working in QM of a pharmaceutical company specialized on liquid an semi-solid formulations for cutaneous and vaginal use.
Since the beginning of the nirosamine dilemma I am in charge of preparing risk assessments for our drug products. First I thought this would have to be done once and will then be finalized…
What a mistake!
Since then I have gained a lot of knowledge on the topic and the best information I got and get is from this community. Many, many thanks to the specialists all over the world who share their enormous expertise concerning all fields of the ongoing nitrosamine journey! Without you I would have been lost many times! Keep on doing such great work, I will follow and learn every day.
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@Wolffi @Viraj @Werner @Srinivasbirudukota @nainshiv Welcome to our Nitrosamine Exchange Community. I am happy you have found our community insightful and resourceful. We owe all that to the contributions of our members. Each of you probably has particular interests in Nitrosamines, so I encourage you to post and actively participate in our discussion. We welcome your expertise and insights here in the community!
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My name is Sydonna Tugwell, a Quality Safety Manager at the Caribbean Public Health Agency (CARPHA) Medicines Quality Control and Surveillance Department. As Quality Safety Manager, I am responsible for ensuring the maintenance of MQCSD quality management system as an ISO/IEC 17025 accredited laboratory by:
*Reviewing and revising standard operating procedures for continuing suitability and to improve productivity.
- Conducting internal audits of the MQCSD quality management system to confirm conformity
- Conduct assessment of two national medicines quality control laboratories against ISO/IEC 17025 Standard.
I also assist in performing quality control testing of finished pharmaceuticals using official methods of analysis.
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Hi,
Good morning.
We are looking for Carvedilol API Nitrosamine issues. How we can control in API itself. We have brand product , having increase in nitrosamine during stability.
Please share experience and thoughts.
Regards,
Sapna
Hi, I am Juan Camilo Henriquez, MSc. I am currently working in the development of analytical methodologies for nitrosamine identification and quantification in finished products in Eurofins Quasfar S.A. (Colombia). I am very happy to be part of this community.
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I am Dr. Srinivas Samudrala, and I operate as an independent GMP Consultant and third-party GMP Auditor from Hyderabad, India, boasting over three decades of experience within the pharmaceutical (API) sector. Throughout my career, I’ve navigated through various positions, including roles in Research and Development (R&D), Quality Assurance (QA), and Regulatory Affairs (RA). I’ve been entrusted with tasks ranging from process development and commercialization to establishing and implementing Quality Management Systems (QMS) in esteemed organizations such as Fleming Labs, Dr. Reddy’s, Inogent Labs, Symed Labs, and served as a Global Quality Auditor at Teva, India.
I’m thrilled to join this group, as I believe it will enrich my expertise and knowledge through the exchange of ideas and valuable insights shared by distinguished speakers and stakeholders.
Hello, I am Brayan Sanchez, a student in practice of pharmaceutical chemistry at Icesi University located in Cali, Colombia. I am in charge of the project related to the analysis of nitrosamine impurities for the Colombian pharmaceutical company Tecnoquimicas. I am interested in learning about this important topic and I am happy to be part of this great group.
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Hi, Everyone this Naved Here. Currently i am working on Quantification of Nitrosamine, NDSRI’S and Genotoxic impurities for formulation as well as API. Its a great time to be here. Thank you @Naiffer_Host for reaching me.
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Dear All… My name is Jesus Acedo. I have a lot experience in mass spectrometers (Agilent, and now Sciex). Happy to help if you have any concern about mass spectrometry.
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A lot of thanks again for the kind words! My name Is Georgi Tchernev and
I am dermatologist and Dermatologic surgeon , dealing and fighting with skin cancers pathogenesis and and surgical treatment since 1999!
I have joined the community with the only one reason or purpose- to have possibility to show to the colleagues and with thinkers the clinicopathologocal correlations after the intake of potentially nitrosamine contaminated drugs and the subsequent development of skin cancer!
Meanwhile it’s also a cry for help and appeal to the scientific community worldwide in order to check the Phototoxicity of all nitrosamines , currently identified in about 300 drugs/ listed in the fda list !
Phototoxicity and photocarcinogenicity of the nitrosamines currently identified in many drugs, might be seen as the most probable and valuable contribution / if confirmed regarding the pathogenesis of Skin cancer . At least as substantial co- factor !
Let’s hope that together we could be stronger when trying to
Find the answers of the questions, mentioned above!
Questions concerning the Nitrosogenesis of skin cancer in the context of oncopharmacogenesis !
Wishing all the best from one of the
Ancient parts of Eastern Europe -
Sofia , Bulgaria
Greetings. My name is Eric Hill, and I currently work at BA Sciences. BA Sciences is a contract analytical lab in the Pharma, Biopharma, and Med Device industries. Among other testing offerings, we perform Nitrosamines testing. I look forward to participating in the discussions on this forum.
Eric Hill
Chief Scientific Officer
BA Sciences
Hi, My name is Sachin Kamble. I am currently Sr Principal Scientist in Formulation Analytical method development at Centaur Pharmaceutical Pvt Ltd India. Happy to be part of this group.
Hello Everyone,
I am Devendra Pandey, working as Sr. Group Leader in Mankind Pharma R&D. Looking after the entire activities of LC-MS/MS especially want to mention burning topic Nitrosamines. Developed/evaluated Number of methods of wide range of Nitrosamines (General Nitrosamines and NDSRI as well). Thanks to all of you for giving me the opportunity to join this knowledgeful platform having a lot intellectual/experts over the topic.
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