Regulatory Highlights-Reference-Cited by-同舟云学术

Regulatory Highlights

Published:2024-02-27 Issue:3 Volume:28 Page:661-665
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Teasdale Andrew¹²^ORCID,Owen Stewart F.¹²

Affiliation:

1. Chemical Development, Pharmaceutical Technology and Development, Operations, AstraZeneca, Macclesfield SK10 2NA, United Kingdom

2. Environmental Protection, Global Sustainability and SHE, Operations, AstraZeneca, Macclesfield SK10 2NA, United Kingdom

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.4c00055

Reference22 articles.

1. EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity: some valsartan medicines being recalled across the EU. European Medicines Agency, July 5, 2018. https://www.ema.europa.eu/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity-some.

2. N-Nitrosamines Impurities in Pharmaceuticals The Abrupt Challenges that Resulted, the Evolving Science, and the Regulatory Framework

3. Reflections on the Impact of Nitrosamine Drug Substance Related Impurities

4. The Nitrosamine “Saga”: Lessons Learned from Five Years of Scrutiny

5. Potential for the Formation of N-Nitrosamines during the Manufacture of Active Pharmaceutical Ingredients: An Assessment of the Risk Posed by Trace Nitrite in Water

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1. Regulatory Highlights;Organic Process Research & Development;2024-08-20