|
Parts per billion of nitrite in microcrystalline cellulose -Pub
|
|
3
|
1261
|
July 3, 2024
|
|
Risk analysis of nitrosamine impurities in liquid products (essences and flavors)
|
|
3
|
879
|
June 28, 2024
|
|
Insights from the Lhasa Limited and IPEC Europe Nitrites collaborative meeting
|
|
1
|
583
|
June 16, 2024
|
|
Lactose, Nitrosamine Risk?
|
|
35
|
3817
|
April 6, 2022
|
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Update: EFPIA workflows for Quality Risk management Jun 2024 v03
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2
|
1484
|
June 4, 2024
|
|
N-nitroso cyclamate
|
|
9
|
795
|
March 15, 2024
|
|
Lack of effect of antioxidants on Biopharmaceutics Classification System (BCS) Class III drug permeability -Pub
|
|
1
|
550
|
March 13, 2024
|
|
Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products
|
|
3
|
1350
|
March 7, 2024
|
|
MCC with nitrite levels of 0.1 ppm or less
|
|
4
|
1545
|
March 4, 2024
|
|
A quick (dumb) question
|
|
10
|
1490
|
January 22, 2024
|
|
Low nitrile crosscarmellose sodium
|
|
0
|
453
|
November 6, 2023
|
|
Personal perspective on N-Nitrosamines and recent revision of guidelines
|
|
7
|
857
|
October 27, 2023
|
|
Variation requirements
|
|
2
|
520
|
October 2, 2023
|
|
Apixaban Drug Substance-Related Impurities (NDSRIs)
|
|
3
|
1815
|
September 15, 2023
|
|
Quantitation of Reactive Nitrosating Agents in Pharmaceutical Excipients for N‑Nitrosamine Risk Assessments
|
|
4
|
1536
|
September 7, 2023
|
|
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
|
|
11
|
4290
|
July 27, 2023
|
|
Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations
|
|
9
|
854
|
July 21, 2023
|
|
IPEC Nitrosamine Questionnaire Q&A Excipients
|
|
6
|
1381
|
June 8, 2023
|
|
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products
|
|
1
|
1025
|
June 5, 2023
|
|
Prediction of Nitrosamine formation from Excipients
|
|
19
|
1998
|
February 8, 2023
|
|
Drug-Nitrite interaction products -Publication review
|
|
2
|
777
|
November 30, 2022
|
|
Nitrite / Nitrosamine levels in Excipients
|
|
0
|
553
|
November 17, 2022
|
|
Risk of Nitrosamine Formation from Nitrites in Aqueous Systems
|
|
0
|
708
|
June 27, 2022
|
|
A Nitrite Excipient Database - Risk Assessment
|
|
6
|
2311
|
June 15, 2022
|
|
New webinar & Live Q&A May 24th by Naiffer Romero! Nitrosamine exchange – a USP’s knowledge community for all-things nitrosamine
|
|
0
|
418
|
April 22, 2022
|
|
Mutagenic Impurities Strategies for Identification and Control - now published
|
|
9
|
584
|
March 2, 2022
|
|
Results from survey on Nitrosamines in Excipients -Any thoughts?
|
|
10
|
813
|
September 23, 2021
|
|
Challenges for API Raw Material & DP regarding Excipient / APIs / Packaging?
|
|
12
|
1586
|
August 17, 2021
|
|
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?
|
|
0
|
409
|
July 20, 2021
|
|
Developing Process for Nitrite-free Excipients?
|
|
1
|
595
|
July 11, 2021
|