Validation of Impurity Methods, Part II

LC-GC North America

Volumn 21, Issue 12, 2003, Pages 1146-1152

  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

ACCURACY; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; POLICY; PRACTICE GUIDELINE; REGISTRATION; REPRODUCIBILITY; REVIEW; VALIDATION PROCESS;

EID: 0347418280     PISSN: 15275949     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (9)

1. J.D. Orr, I.S. Krull, and M.E. Swartz, LCGC 21(7), 626 (2003).
2. 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).
3. 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).
4. Draft Guidance for Industry: Analytical Procedures and Methods Validation (U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Division of Research, Rockville, Maryland, August 2000).
5. Reviewer Guidance: Validation of Chromatographic Methods (U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland, November 1994).
6. ICH Q1A(R2) Stability Testing of New Drug Substances and Products (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, February 2003).
7. ICH Q1B Stability Testing. Photastability Testing of New Drug Substances and Products (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, November 1996).
8. C.H. Dubin, Pharm. Form. Qual. 4(6), 22 (December 2002-January 2003).
9. The United States Pharmacopeia 24-National Formulary 19, General Information, (1225) Validation of Compendial Methods (United States Pharmacopeial Convention, Inc., Rockville, Maryland, 1999) pp. 2150-2151.