Impurities in drug products;Verunreinigungen in pharmazeutischen produkten

Pharmazeutische Industrie

Volumn 69, Issue 5, 2007, Pages 624-628

  Zeine, Christian ^a  

^a LGC   (United Kingdom)

Author keywords

Analysenzertifikat; Guidelines; ICH leitlinien; Referenzstandards; Verunreinigungen

Indexed keywords

ALCOHOL;

ARTICLE; DRUG IMPURITY; DRUG MANUFACTURE; QUALITY CONTROL; QUANTITATIVE ANALYSIS; VALIDATION PROCESS;

EID: 34447544561     PISSN: 0031711X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. ICH-Guideline Q3A(R1) - Impurities in New Drug Substances. http://www. ich.org/LOB/media/MEDIA422.pdf
2. ICH-Guideline Q3B(R2) - Impurities in New Drug Products. http://www.ich.org/LOB/media/MEDIA421.pdf
3. Richtlinie 2001/83/EG vom 6. November 2001 zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel. Amtsblatt der Europäischen Gemeinschaften. S. L311/105. http://europa.eu.int/eur-lex/pri/de/oj/dat/ 2001/l_311/l_ 31120011128de00670128.pdf
4. st Annual Scientific Meeting. 28. September 2004. Iselin (New Jersey).
5. LGC Promochem. Interne Mitteilung.
6. European Pharmacopoeia. Suppl. 5.5 (English version). General text 5.10. S. 4145 ff.
7. European Pharmacopoeia 5.0. Vol. 1 (English version). General monograph (2034). S. 586 ff.
8. ICH-Guideline Q3C(R3) - Impurities: Guideline for Residual Solvents. http://www.ich.org/LOB/media/MEDIA423.pdf
9. FDA-Draft Guidance for Industry - ANDAs: Impurities in Drug Substances. http://www.fda.gov/CDER/guidance/6422dft.pdf
10. European Pharmacopoeia 5.0. Vol. 2 (English version). Ibuprofen-Monographie (0721). S. 1785 ff.
11. LGC Promochem. Interne Mitteilung.