Relationship between HPLC precision and number of significant figures when reporting impurities and when setting specifications-Reference-Cited by-同舟云学术

Relationship between HPLC precision and number of significant figures when reporting impurities and when setting specifications

Published:2006-05 Issue:2 Volume:41 Page:442-448
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Agut Christophe,Segalini Audrey,Bauer Michel,Boccardi Giovanni

Publisher

Elsevier BV

Subject

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

Reference21 articles.

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3. Q3A(R): Impurities in New Drug Substances (Revised Guideline), International Conference of Harmonization, 2002, www.ICH.org, accessed June 3rd, 2005.

4. Q3B: Impurities in New Drug Products (Revised Guideline), International Conference of Harmonization, 2002, www.ICH.org, accessed June 3rd, 2005.

5. Reviewer Guidance, Validation of Chromatographic Methods, November;Center for Drug Evaluation and Research (CDER),1994

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