Organic impurities in chemical drug substances

Pharmaceutical Technology Europe

Volumn 17, Issue 10, 2005, Pages 24-32

  Grekas, Nikolaos ^a  

^a ELPEN Pharmaceuticals   (Greece)

Author keywords

[No Author keywords available]

Indexed keywords

AMLODIPINE BESYLATE; BENZENE DERIVATIVE; BENZENESULFONIC ACID; BUDESONIDE; CEFAMANDOLE; CEFAMANDOLE NAFATE; CHLORIDE; CIPROFLOXACIN; CLARITHROMYCIN; ENALAPRIL MALEATE; LEVDROPROPIZINE; MALIC ACID; ORGANIC COMPOUND; RANITIDINE; UNCLASSIFIED DRUG;

ARTICLE; DRUG IMPURITY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SYNTHESIS; ENANTIOMER; GAS CHROMATOGRAPHY; GOOD MANUFACTURING PRACTICE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MASS SPECTROMETRY; MATRIX ASSISTED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY; MEDICAL LITERATURE; MEDICAL TECHNOLOGY; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; QUALITY CONTROL; QUANTITATIVE ANALYSIS; STEREOISOMERISM; THIN LAYER CHROMATOGRAPHY;

EID: 26444518779     PISSN: 01646826     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (12)

1. www.ich.org/cache/compo/363-272-1.html #Q3A(R)
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4. S. Görög, Anal. Bioanal. Chem. 377, 852-862 (2003).
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8. J. Bertram, Pharmeuropa 15.2, (April) 280-289 (2003).
9. R. Nageswara Rao and V. Nagaraju, J. Pharm. Biomed. Anal. 33(3), 335-377 (2003).
10. General chapters <466>, "Ordinary impurities" and <1086>, "Impurities in official articles," in USP 28 - NF 23 (US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland 20852, USA, 2004).
11. USP Guideline for Submitting a Request for Revision of the USP/NF, Chapter One, Non-Complex Drug Substances and Products, http://www.usp.org
12. General chapter 5.10, Control of impurities in substances for pharmaceutical use and general monograph 01/2005:2034, Substances for pharmaceutical use, in European Pharmacopoeia, 5th Edition (EDQM, 226 avenue de Colmar BP 907, F-67029 Strasbourg, France, 2004), pp 559-561 and 586-587.