Validation of impurity methods, part I

LC-GC North America

Volumn 21, Issue 7, 2003, Pages 626-633

  Orr, John D ^a   Krull, Ira S ^b   Swartz, Michael E ^c  

^a EISAI RESEARCH INSTITUTE   (United States)

^b NORTHEASTERN UNIVERSITY   (United States)

^c WATERS CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETONITRILE; BENZENE DERIVATIVE; CARBON TETRACHLORIDE;

ACCURACY; DRUG IMPURITY; DRUG INDUSTRY; DRUG LABELING; DRUG MANUFACTURE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; POLICY; PRACTICE GUIDELINE; QUALITY CONTROL; REPRODUCIBILITY; REVIEW; STANDARDIZATION; TERATOGENICITY; VALIDATION PROCESS;

EID: 0037662136     PISSN: 15275949     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (14)

1. Draft Guidance for Industry: Analytical Procedures and Methods Validation (U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Division of Research, Rockville, Maryland, August 2000).
2. ICH Q2B Validation of Analytical Procedures: Methodology (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, May 1997).
3. ICH Q2A Text on Validation of Analytical Procedures (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, March 1995).
4. "Reviewer Guidance: Validation of Chromatographic Methods" (U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland, November 1994).
5. ICH Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, November 2000).
6. United States Pharmacopeia 26 - National Formulary 21 (United States Pharmacopeial Convention, Inc., Rockville, Maryland, 2002).
7. L. Huber, in Validation and Qualification in Analytical Laboratories (Interpharm/CRC Press, Boca Raton, Florida, 1998).
8. ICH Q3A(R) Impurities in New Drug Substances (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, February 2002).
9. O. Repič, in Principles of Process Research and Development in the Pharmaceutical Industry (John Wiley & Sons, Inc., New York, 1998), pp. 1-54.
10. United States Pharmacopeia 24 - National Formulary 19 (United States Pharmacopeial Convention, Inc., Rockville, Maryland, 1999), pp. 1862.
11. ICH Q3C Impurities: Guideline for Residual Solvents (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, July 1997).
12. United States Pharmacopeia 24 - National Formulary 19 (United States Pharmacopeial Convention, Inc., Rockville, Maryland, 1999), pp. 1877-1878.
13. United States Pharmacopeia 24 - National Formulary 19 (United States Pharmacopeial Convention, Inc., Rockville, Maryland, 1999), pp. 3-4.
14. ICH Q3A(R) Impurities in New Drug Substances (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, February 2002), attachment 1, pp. 8.