Differentiating organic carbon analysis for characterization of purified water and identification and quantification of residues in aqueous rinses from cleaning validation;Differenzierende TOC-bestimmung zur charakterisierung von reinstwasser und ruckstandsprufung im verlauf der reinigungsvalidierung

Pharmazeutische Industrie

Volumn 62, Issue 5, 2000, Pages 377-381

  Woiwode, Wolfgang ^a   Huber, Stefan ^b  

^a TECHPharm Woiwode GmbH   (Germany)

^b DOC Labor   (Germany)

Author keywords

Fingerprint; Gesamtkohlenstoff; Kohlenstoffdetektor; Kontamination; LC OCD; Post Final Rinse; Reinigungvalidierung; TOC gesamt; Wasseruntersuchungen

Indexed keywords

ORGANIC COMPOUND; WATER;

AQUEOUS SOLUTION; ARTICLE; CLEANING; DRUG INDUSTRY; LIQUID CHROMATOGRAPHY; QUANTITATIVE ASSAY; RESIDUE ANALYSIS; TOTAL ORGANIC CARBON; VALIDATION PROCESS; WATER ANALYSIS; WATER CONTAMINATION; WATER SUPPLY; WATER TREATMENT;

EID: 0033933250     PISSN: 0031711X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (5)

1. Europäisches Arzneibuch 1997, Änderung 2.2.44 Total Organic Carbon in Water for Pharmaceutical Use (1999) -
2. U.S. Pharmacopeia, National Formulary, Fifth Supplement, <643> Total Organic Carbon -
3. Huber, S. A., Frimmel, F. H., A Liquid Chromatographic System with Multi-Detection for the direct Analysis of Hydrophilic Organic Compounds in Natural Waters, Fresen, J. Anal. Chem. 342, 198 (1991) -
4. Huber, S. A., Frimmel, F. H., Flow Injection Analysis of Organic and Inorganic Carbon in the Low-ppb range, Anal. Chem. 63, 2122 (1991) -
5. Validation of Analytical Procedures, Dokument ICH-Q2A, März 1995 -