Validation and implementation of in-process control HPLC assays for active pharmaceutical ingredients

LC-GC North America

Volumn 22, Issue 10, 2004, Pages 1006-1009

  Wrezel, P W ^a   Chion, I ^a   Hussain, M S ^a  

^a REGIS TECHNOLOGIES INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANALYTIC METHOD; ANALYTICAL PARAMETERS; ARTICLE; CHEMICAL REACTION; DRUG INDUSTRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PHARMACEUTICAL ENGINEERING; QUANTITATIVE ANALYSIS; REACTION ANALYSIS; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

EID: 5444268053     PISSN: 15275949     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (2)

1. International Conference on Harmonization Guideline for Industry, "Q2A Text on Validation of Analytical Procedures," October 1994.
2. International Conference on Harmonization Guideline for Industry, "Q2B Validation of Analytical Procedures: Methodology," November 1996.