Content uniformity and assay requirements in current regulations

Journal of Chromatography A

Volumn 1156, Issue 1-2 SPEC. ISS., 2007, Pages 206-212

  Bánfai, Balázs ^a   Ganzler, Katalin ^b   Kemény, Sándor ^a  

^a BUDAPEST UNIVERSITY OF TECHNOLOGY AND ECONOMICS   (Hungary)

^b GEDEON RICHTER LTD   (Hungary)

Author keywords

Acceptance criteria; Assay; Content uniformity; Pharmacopoeia; Random effects ANOVA; Taguchi's quadratic loss function; Tolerance range

Indexed keywords

CHROMATOGRAPHY; PHARMACODYNAMICS; REGULATORY COMPLIANCE;

ACCEPTANCE CRITERIA; CONTENT UNIFORMITY; CURRENT REGULATIONS; PHARMACOPOEIA; RANDOM EFFECTS ANOVA;

BIOASSAY;

ANALYSIS OF VARIANCE; ARTICLE; CALCULATION; MATHEMATICAL ANALYSIS; MEDICAL LITERATURE; METHODOLOGY; PRIORITY JOURNAL;

MATHEMATICS; PHARMACEUTICAL PREPARATIONS; PHARMACOPOEIAS; TABLETS;

EID: 34250680185     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chroma.2006.10.067     Document Type: Article

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