Identification of Pharmaceutical Impurities in Formulated Dosage Forms-Reference-Cited by-同舟云学术

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Identification of Pharmaceutical Impurities in Formulated Dosage Forms

Published:2011-04 Issue:4 Volume:100 Page:1228-1259
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Pan Changkang,Liu Frances,Motto Michael

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference137 articles.

1. Guidance for Industry, Q3A Impurities in New Drug Substance;US Food and Drug Administration,2003

2. Guidance for Industry, Q3B Impurities in New Drug Products;US Food and Drug Administration,2006

3. Guidance for Industry, Q3C Impurities: Residual Solvents;US Food and Drug Administration,1997

4. Draft Guidance for Industry, AND As: Impurities in Drug Substances;US Food and Drug Administration,2005

5. Draft Guidance for Industry, ANDAs: Impurities in Drug Products;US Food and Drug Administration,2005

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2. Analytical Methodologies to Detect N-Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices;Chemical Research in Toxicology;2024-08-19

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