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Lack of effect of antioxidants on Biopharmaceutics Classification System (BCS) Class III drug permeability -Pub
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1
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533
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March 13, 2024
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Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products
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3
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1263
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March 7, 2024
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MCC with nitrite levels of 0.1 ppm or less
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4
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1475
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March 4, 2024
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A quick (dumb) question
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10
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1418
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January 22, 2024
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Low nitrile crosscarmellose sodium
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0
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449
|
November 6, 2023
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Personal perspective on N-Nitrosamines and recent revision of guidelines
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7
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819
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October 27, 2023
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Variation requirements
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2
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471
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October 2, 2023
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Apixaban Drug Substance-Related Impurities (NDSRIs)
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3
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1714
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September 15, 2023
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Quantitation of Reactive Nitrosating Agents in Pharmaceutical Excipients for N‑Nitrosamine Risk Assessments
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4
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1426
|
September 7, 2023
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FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
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11
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4037
|
July 27, 2023
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Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations
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9
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806
|
July 21, 2023
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IPEC Nitrosamine Questionnaire Q&A Excipients
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6
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1238
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June 8, 2023
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A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products
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1
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1006
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June 5, 2023
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Prediction of Nitrosamine formation from Excipients
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19
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1868
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February 8, 2023
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Drug-Nitrite interaction products -Publication review
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2
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708
|
November 30, 2022
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Nitrite / Nitrosamine levels in Excipients
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0
|
550
|
November 17, 2022
|
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Risk of Nitrosamine Formation from Nitrites in Aqueous Systems
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0
|
687
|
June 27, 2022
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A Nitrite Excipient Database - Risk Assessment
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6
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2117
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June 15, 2022
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New webinar & Live Q&A May 24th by Naiffer Romero! Nitrosamine exchange – a USP’s knowledge community for all-things nitrosamine
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0
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411
|
April 22, 2022
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Mutagenic Impurities Strategies for Identification and Control - now published
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9
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513
|
March 2, 2022
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Results from survey on Nitrosamines in Excipients -Any thoughts?
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10
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798
|
September 23, 2021
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Challenges for API Raw Material & DP regarding Excipient / APIs / Packaging?
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12
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1477
|
August 17, 2021
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Many excipientsuppliers are using the IPEC Questionnaire for Excipient Nitrosamine Risk Evaluation to conduct nitrosamine risk assessments. Does FDA accept prepared questionnaires,such as the one developed by IPEC, as a valid risk assessment tool?
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0
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404
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July 20, 2021
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Developing Process for Nitrite-free Excipients?
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1
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566
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July 11, 2021
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