Parts per billion of nitrite in microcrystalline cellulose by ion chromatography mass spectrometry with isotope labeled internal standard

Author:

Zhu KoudiORCID,Kerry Michael,Serr Barbara,Mintert Markus

Funder

Ian's Friends Foundation

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference26 articles.

1. The effects of nitrate, nitrite and N-nitroso compounds on human health: a review;Bruning-Fann;Vet. Hum. Toxicol.,1993

2. ECA academy, Valsartan: what caused the contamination? 〈https://www.gmp-compliance.org/gmp-news/valsartan-what-caused-the-contamination/〉, 2018 (accessed 26 July 2018).

3. FDA news release, FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications December 11, 2018. 〈https://www.fda.gov/news-events/press-announcements/fda-warns-api-manufacturer-involved-valsartan-recall-provides-information-patients-taking-these〉.

4. Critical analysis of drug product recalls due to nitrosamine impurities;Bharate;J. Med. Chem.,2021

5. Health Canada, Guidance on nitrosamine impurities in medications. 〈https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/medications-guidance.html/〉, 2022 (accessed 1 Sep 2022).

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