Residual solvent analysis in pharmaceuticals

Pharmaceutical Technology Europe

Volumn 14, Issue 12, 2002, Pages 26-28

  Dwivedi, Anil M ^a  

^a West Pharmaceutical Services Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

1,1,1 TRICHLOROETHANE; 1,1,2 TRICHLOROETHANE; 1,2 DICHLOROETHANE; 2 ETHOXYETHANOL; 2 HEXANONE; 2 METHOXYETHANOL; ACETIC ACID; ACETONITRILE; BENZENE; CARBON TETRACHLORIDE; CHLOROBENZENE; CHLOROFORM; CUMENE; CYCLOHEXANE; DICHLOROMETHANE; DIOXANE; DRUG SOLVENT; ETHYLENE GLYCOL; EXCIPIENT; FORMAMIDE; HEXANE; METHANOL; N,N DIMETHYLACETAMIDE; N,N DIMETHYLFORMAMIDE; NITROMETHANE; PYRIDINE; TETRAHYDROFURAN; TOLUENE; UNINDEXED DRUG; XYLENE;

ANALYTIC METHOD; CARCINOGENICITY; DRUG CLASSIFICATION; DRUG INDUSTRY; DRUG MANUFACTURE; GOOD MANUFACTURING PRACTICE; HEALTH HAZARD; HUMAN; MEDICAL LITERATURE; PRACTICE GUIDELINE; REFERENCE VALUE; RESIDUE ANALYSIS; RESPONSIBILITY; RISK BENEFIT ANALYSIS; SHORT SURVEY; TOXICITY; VOLATILIZATION;

EID: 0036897889     PISSN: 01646826     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (7)

1. J.T. Rubino and S.H. Yalkowsky, "Effects of cosolvents on solubilization drugs," Pharm. Res. 4, 220-229 (1987).
2. L. Borka and J.K. Habelian, "Polymorphs, solvates and solubility," Acta Pharm. Jugosl. 40, 71-83 (1990).
3. S.R. Byrn, Solid-State Chemistry of Drugs (Academic Press, New York, New York, USA, 1982) pp. 79-148.
4. ICH Harmonized Tripartite Guideline for Residual Solvents, Step 4, 17 July 1997.
5. USP 25-NF 20 (US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland 20852, USA, 2002).
6. Section 5.4, European Pharmacopoeia, 4th Edition (EDQM, 226, avenue de Colmar BP 907, F-67029 Strasbourg, France, 2002).
7. Section 5.1, "Residual solvents test," Japanese Pharmacopoeia, Edition XIV (National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo 158, Japan, 2001).