Precision from drug stability studies: Investigation of reliable repeatability and intermediate precision of HPLC assay procedures

Journal of Pharmaceutical and Biomedical Analysis

Volumn 38, Issue 4, 2005, Pages 653-663

  Ermer, Joachim ^a   Arth, Christoph ^b   De Raeve, Phillippe ^c   Dill, Donald ^d   Friedel, Horst Dieter ^e   Höwer Fritzen, Heidi ^f   Kleinschmidt, Gerd ^a   Köller, Gerhard ^g   Köppel, Heidi ^h   Kramer, Mathias ⁱ   Maegerlein, Markus ^j   Schepers, Udo ^h   Wätzig, Hermann ^h  

^a SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

^b Schwarz Pharma AG   (Germany)

^c Quality Assistance ^*  (Belgium)

^d AandM StabTest GmbH   (Germany)

^e BAYER PHARMA AG   (Germany)

^f Analytical Development and Stability Testing   (Germany)

^g BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^h TECHNICAL UNIVERSITY OF BRAUNSCHWEIG   (Germany)

ⁱ QA Stability   (Switzerland)

^j ABBOTT GMBH AND CO KG   (Germany)

more..

Author keywords

Analysis of variances; Analytical variability; Drug product; Drug substance; Regression; Reproducibility

Indexed keywords

REAGENT;

ACCURACY; AEROSOL; ANALYSIS OF VARIANCE; ARTICLE; CALCULATION; CREAM; DRUG DEGRADATION; DRUG SOLUTION; DRUG STABILITY; GEL; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; OINTMENT; OPERATOR; PRIORITY JOURNAL; REGRESSION ANALYSIS; RELIABILITY; REPRODUCIBILITY; STATISTICAL SIGNIFICANCE; SUSPENSION; TABLET FORMULATION;

ALGORITHMS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; GERMANY; LINEAR MODELS; OINTMENTS; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; SPECTROPHOTOMETRY, ULTRAVIOLET; TABLETS;

EID: 20644433545     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2005.02.009     Document Type: Article

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