Defining drug purity through chromatographic and related methods: Current status and perspectives

Journal of Chromatography B: Biomedical Applications

Volumn 689, Issue 1, 1997, Pages 137-153

  Krstulovic, A M ^a   Lee, C R ^a  

^a SANOFI   (France)

Author keywords

Drug purity; Drugs

Indexed keywords

ELIPRODIL; FLUPAROXAN; MIZOLASTINE;

CHIRALITY; CONFERENCE PAPER; DRUG CONTROL; DRUG DEGRADATION; DRUG IDENTIFICATION; DRUG IMPURITY; DRUG PURITY; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PRIORITY JOURNAL; QUALITY CONTROL; SOLID STATE; TECHNIQUE; THERMAL ANALYSIS; THIN LAYER CHROMATOGRAPHY; ULTRAVIOLET SPECTROPHOTOMETRY; X RAY DIFFRACTION;

CHROMATOGRAPHY; ELECTROPHORESIS; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL;

EID: 0031557148     PISSN: 15726495     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-4347(96)00439-2     Document Type: Conference Paper

References (3)

1. [1] ICH Harmonized Tripartite Guideline, Q3A: Impurity Testing Guidelines, Impurities in New Drug Substances (step 4).
2. [2] ICH Harmonized Tripartite Guideline, Q3B: Impurities in New Drug Products (step 2).
3. [3] K.D. Altria, J. Chromatogr., 636 (1993) 125-132.