Impurities in Active Pharmaceutical Ingredients and Drug Products: A Critical Review-Reference-Cited by-同舟云学术

Impurities in Active Pharmaceutical Ingredients and Drug Products: A Critical Review

Published:2024-07-26 Issue: Volume: Page:1-21
ISSN:1040-8347
Container-title:Critical Reviews in Analytical Chemistry
language:en
Short-container-title:Critical Reviews in Analytical Chemistry

Author:

Finotti Cordeiro Cleydson¹,Lopardi Franco Lucas¹,Teixeira Carvalho Diogo¹,Bonfilio Rudy¹^ORCID

Affiliation:

1. Faculty of Pharmaceutical Sciences, Federal University of Alfenas (UNIFAL-MG), Alfenas, Minas Gerais, Brazil

Funder

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brazil

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/10408347.2024.2384046

Reference81 articles.

1. ‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances

2. World Health Organization. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials: Volume 2: Good Manufacturing Practices and Inspection 10th ed. https://www.who.int/publications/i/item/9789240086081 (accessed Jul 19 2024).

3. International Conference on Harmonization (ICH). Impurities in New Drug Substances Q3A (R2). https://www.ich.org/page/quality-guidelines (accessed Jul 10 2023).

4. International Conference on Harmonization (ICH). Impurities in New Drug Products Q3B (R2). https://www.ich.org/page/quality-guidelines (accessed Jul 10 2023).

5. International Conference on Harmonization (ICH). Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7 (R2). https://www.ich.org/page/multidisciplinary-guidelines (accessed Jul 13 2023).