|
Low nitrite excipients
|
|
9
|
1092
|
April 12, 2024
|
|
N-nitroso cyclamate
|
|
9
|
342
|
March 15, 2024
|
|
Lack of effect of antioxidants on Biopharmaceutics Classification System (BCS) Class III drug permeability -Pub
|
|
1
|
301
|
March 13, 2024
|
|
MEGLUMINE (Methylglucamine)
|
|
15
|
1738
|
March 12, 2024
|
|
Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products
|
|
3
|
587
|
March 7, 2024
|
|
MCC with nitrite levels of 0.1 ppm or less
|
|
4
|
701
|
March 4, 2024
|
|
A quick (dumb) question
|
|
10
|
780
|
January 22, 2024
|
|
Risk analysis of nitrosamine impurities in liquid products (essences and flavors)
|
|
2
|
358
|
November 14, 2023
|
|
Nitrosamnes in PMs & Excipients Questions
|
|
4
|
629
|
November 6, 2023
|
|
Low nitrile crosscarmellose sodium
|
|
0
|
276
|
November 6, 2023
|
|
Parts per billion of nitrite in microcrystalline cellulose -Pub
|
|
2
|
650
|
October 28, 2023
|
|
Personal perspective on N-Nitrosamines and recent revision of guidelines
|
|
7
|
631
|
October 27, 2023
|
|
Variation requirements
|
|
2
|
365
|
October 2, 2023
|
|
Apixaban Drug Substance-Related Impurities (NDSRIs)
|
|
3
|
953
|
September 15, 2023
|
|
Quantitation of Reactive Nitrosating Agents in Pharmaceutical Excipients for N‑Nitrosamine Risk Assessments
|
|
4
|
986
|
September 7, 2023
|
|
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
|
|
11
|
2686
|
July 27, 2023
|
|
Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations
|
|
9
|
610
|
July 21, 2023
|
|
IPEC Nitrosamine Questionnaire Q&A Excipients
|
|
6
|
916
|
June 8, 2023
|
|
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products
|
|
1
|
650
|
June 5, 2023
|
|
Prediction of Nitrosamine formation from Excipients
|
|
19
|
1276
|
February 8, 2023
|
|
Drug-Nitrite interaction products -Publication review
|
|
2
|
603
|
November 30, 2022
|
|
Nitrite / Nitrosamine levels in Excipients
|
|
0
|
430
|
November 17, 2022
|
|
Risk of Nitrosamine Formation from Nitrites in Aqueous Systems
|
|
0
|
555
|
June 27, 2022
|
|
A Nitrite Excipient Database - Risk Assessment
|
|
6
|
1335
|
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
|
293
|
April 22, 2022
|
|
Lactose, Nitrosamine Risk?
|
|
35
|
2166
|
April 6, 2022
|
|
Mutagenic Impurities Strategies for Identification and Control - now published
|
|
9
|
402
|
March 2, 2022
|
|
Results from survey on Nitrosamines in Excipients -Any thoughts?
|
|
10
|
599
|
September 23, 2021
|
|
Challenges for API Raw Material & DP regarding Excipient / APIs / Packaging?
|
|
12
|
943
|
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
|
287
|
July 20, 2021
|