Guidelines for the design, implementation, and interpretation of validations for chromatographic methods used to quantitate leachables/ extractables in pharmaceutical solutions

Journal of Liquid Chromatography and Related Technologies

Volumn 27, Issue 20, 2004, Pages 3141-3176

  Jenke, Dennis R ^a  

^a BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Chromatographic methods; Design; Extractables; Implementation; Interpretation; Leachables; Pharmaceutical solutions; Validation

Indexed keywords

DRUG PRODUCTS; EXTRACTION; SOLUTIONS;

CHROMATOGRAPHIC METHODS; PHARMACEUTICAL SOLUTIONS;

CHROMATOGRAPHIC ANALYSIS;

ANALYTIC METHOD; CHROMATOGRAPHY; DRUG FORMULATION; EXPERIMENTAL DESIGN; PRACTICE GUIDELINE; REVIEW; SOLUTION AND SOLUBILITY; SYSTEM ANALYSIS; VALIDATION PROCESS;

EID: 8844231740     PISSN: 10826076     EISSN: None     Source Type: Journal    
DOI: 10.1081/JLC-200034862     Document Type: Review

References (3)

1. Validation of Compendial Methods. In USP 27; United States Pharmacopeial Convention, Inc.: Rockville, Maryland, 2003; 2622-2625.
2. Guideline for Industry. Q2A Text on Validation of Analytical Procedures; US Dept. of Health and Human Services: Rockville, Maryland, 1995 (Published in the Federal Register, 60 FR 11260, on March 1, 1995.).
3. Guideline for Industry. Q2B Validation of Analytical Procedures: Methodology; US Dept. of Health and Human Services: Rockville, Maryland, 1996 (Published in the Federal Register, 62 FR 27464, on May 19, 1997).