Nitrite in Pharmaceutical Manufacturing Water: Development of an Ultra-Sensitive Analytical Method, Typical Data, and Discussion of Potential Nitrosamine Formation in Drug Substance and Drug Product from Water-Reference-Cited by-同舟云学术

Nitrite in Pharmaceutical Manufacturing Water: Development of an Ultra-Sensitive Analytical Method, Typical Data, and Discussion of Potential Nitrosamine Formation in Drug Substance and Drug Product from Water

Published:2024-06-12 Issue:7 Volume:28 Page:2614-2622
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Suresh Kumar A. B.¹,Dey Debasis¹^ORCID,Balaji T. S.¹,Karthik Haridoss¹,Sathishkumar K.¹,McDaid Paul²^ORCID,Fitzpatrick Brian³,Awasthi Atul¹,Davies Simon²,Dirat Olivier⁴^ORCID

Affiliation:

1. Pfizer Healthcare India PVT Ltd., Synergy, IITM Research Park, Kanagam Road, Chennai 600113, India

2. Pfizer Process Development Centre, RCMF, Shanbally, Ringaskiddy, Cork P43 X336, Ireland

3. Pfizer Grange Castle, Grange Castle, Clondalkin, Co., Dublin D02, Ireland

4. Pfizer Global Regulatory Sciences, CMC Advisory Office, Sandwich CT13 9NJ, U.K.

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.4c00037

Reference24 articles.

1. Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products

2. The contamination of valsartan and other sartans, part 1: New findings

3. The contamination of valsartan and other sartans, Part 2: Untargeted screening reveals contamination with amides additionally to known nitrosamine impurities

4. CHMP Assessment Report of Article 5 (3) ‘Nitrosamines Impurities in Human Medicinal Products’ and Related Guidance, EMA/369136/2020 European Medicines Agency, June 25, 2020. https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-assessment-report_en.pdf (accessed April 26, 2024).

5. Temporary Interim Limits for NMBA, DIPNA and EIPNA Impurities in Sartan Blood Pressure Medicines, EMA/351053/2019 rev 1; European Medicines Agency, 2020. https://www.ema.europa.eu/en/medicines/human/referrals/angiotensin-ii-receptor-antagonists-sartans-containing-tetrazole-group (accessed April 26, 2024).