|
Apixaban Drug Substance-Related Impurities (NDSRIs)
|
|
3
|
1697
|
September 15, 2023
|
|
Considerations for high-risk unit operations
|
|
2
|
562
|
August 18, 2023
|
|
Nitrosamines from tertiary amines in azabicycles
|
|
4
|
458
|
June 9, 2023
|
|
IPEC Nitrosamine Questionnaire Q&A Excipients
|
|
6
|
1229
|
June 8, 2023
|
|
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products
|
|
1
|
998
|
June 5, 2023
|
|
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis
|
|
2
|
1601
|
May 23, 2023
|
|
Indigo carmine as secondary amine?
|
|
7
|
787
|
May 16, 2023
|
|
The true role of NitrXtes in NDSRIs?
|
|
2
|
467
|
April 3, 2023
|
|
A Survey of Industrial N-nitrosamine Discharges in Switzerland -Pub
|
|
0
|
335
|
March 1, 2023
|
|
Prediction of Nitrosamine formation from Excipients
|
|
19
|
1859
|
February 8, 2023
|
|
Nitrosamine risks that may arise from the filters
|
|
2
|
861
|
January 4, 2023
|
|
Calcium Phosphate- Opadry-Lhasa
|
|
0
|
438
|
December 21, 2022
|
|
E&L challenges and pitfalls in connection with NAs & NDRSIs
|
|
0
|
375
|
December 12, 2022
|
|
Drug-Nitrite interaction products -Publication review
|
|
2
|
706
|
November 30, 2022
|
|
Nitrocellulose blister material as a source of N-nitrosamine (peer-review-article)
|
|
2
|
1295
|
September 1, 2022
|
|
API seem to form N-nitrosamines upon oxidation (e.g. air) and without the presence of nitrosonium ions
|
|
1
|
709
|
August 4, 2022
|
|
Exact Root causes for NDMA in Metformin & NDSRI's Impurities in Varenicline, Quinapril & Orphenadrine
|
|
4
|
1089
|
July 7, 2022
|
|
Risk of Nitrosamine Formation from Nitrites in Aqueous Systems
|
|
0
|
684
|
June 27, 2022
|
|
A Nitrite Excipient Database - Risk Assessment
|
|
6
|
2091
|
June 15, 2022
|
|
Drug substance-related impurities (NDSRIs) in Drug product and Drug substances
|
|
7
|
3328
|
June 8, 2022
|
|
Anybody dealing with Nitrosopiparazines?
|
|
1
|
442
|
June 7, 2022
|
|
FDA Root Causes of Nitrosamines Formation Fellowship
|
|
0
|
310
|
April 14, 2022
|
|
Risk of Nitrosamine in packaging materials, risk or control?
|
|
2
|
1818
|
April 1, 2022
|
|
NDMA in German Beer - A success Story
|
|
1
|
341
|
January 25, 2022
|
|
Excipients, morpholine?
|
|
4
|
379
|
October 18, 2021
|
|
Nitrosamines - Elastomers perspective (PDA publication)
|
|
8
|
758
|
October 16, 2021
|
|
Results from survey on Nitrosamines in Excipients -Any thoughts?
|
|
10
|
798
|
September 23, 2021
|
|
Excipient & Nitrosamines -Q&A session
|
|
0
|
336
|
September 16, 2021
|
|
Challenges for API Raw Material & DP regarding Excipient / APIs / Packaging?
|
|
12
|
1469
|
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
|
404
|
July 20, 2021
|