A multianalyte LC-MS/MS method for accurate quantification of Nitrosamines in Olmesartan tablets

Author:

Pawar Namdev,Bhardwaj AparnaORCID,Vora Amisha,Sharma Sanjay

Publisher

Elsevier BV

Reference37 articles.

1. N-Nitrosodimethylamine (NDMA) in food and beverages: a comparison in context to drinking water;Chowdhury;Hum. Ecol. Risk Assess.,2014

2. European Medicines Agency (2020); Nitrosamine impurities in human medicinal products; EMEA/H/A-5(3)/1490 https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-assessment-report_en.pdf.

3. IPA Guidance on Nitrosamines. (2022). Published by Indian Pharmaceutical Alliance available at: https://www.ipa-india.org/wp-content/uploads/2023/07/guideline-05072023c.pdf.

4. U.S. Food and Drug Administration,2021

5. Understanding the molecular-pharmaceutical basis of Sartan recalls focusing on valsartan;Ray;Glob. Cardiol. Sci. Practice,2021

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