Impurities and its importance in pharmacy

International Journal of Pharmaceutical Sciences Review and Research

Volumn 3, Issue 2, 2010, Pages 66-71

  Prabu, S Lakshmana ^a   Suriyaprakash, T N K ^b  

^a ANNA UNIVERSITY   (India)

^b Periyar College of Pharmaceutical Sciences for Girls   (India)

Author keywords

ICH; Impurities; Pharmaceutical products; Pharmaceutical substance

Indexed keywords

ACETONITRILE; ALCOHOL; AMMONIA; CARBON DIOXIDE; CARBON TETRACHLORIDE; CHLOROFORM; DICHLOROMETHANE; ETHER; EXCIPIENT; FORMAMIDE; HEXANE; METHANOL; N,N DIMETHYLFORMAMIDE; PENTANE; TOLUENE; WATER;

AGING; CHEMICAL STRUCTURE; COLUMN CHROMATOGRAPHY; CRYSTALLIZATION; DECARBOXYLATION; DISTILLATION; DRUG FORMULATION; DRUG IMPURITY; DRUG INDUSTRY; DRUG PACKAGING; DRUG SAFETY; ENVIRONMENTAL FACTOR; EXCIPIENT COMPATIBILITY; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMIDITY; HYDROLYSIS; INFRARED SPECTROSCOPY; IONIZATION; LIQUID LIQUID EXTRACTION; MEDICAL SOCIETY; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; OPTICAL ROTATION; PH; PHARMACEUTICAL CARE; PRACTICE GUIDELINE; REVIEW; SOLUBILITY; SUPERCRITICAL FLUID EXTRACTION; THIN LAYER CHROMATOGRAPHY; ULTRAVIOLET SPECTROSCOPY; WATER ABSORPTION;

EID: 79952031372     PISSN: None     EISSN: 0976044X     Source Type: Journal    
DOI: None     Document Type: Review

References (12)

1. U.S. Food and Drug Administration. Guidance for Industry, Q3A Impurities in New Drug Substances. February 2003.
2. U.S. Food and Drug Administration. Guidance for Industry, Q3B Impurities in New Drug Products. July 2006.
3. Gorog S (Ed.), Identification and Determination of Impurities in Drugs, Elsevier Science B.V, Amsterdam, 2000.
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7. ICH Harmonised Tripartite Guidelines: Impurities in New Drug Substances Q3A(R), 10 February 2003; Impurities in New Drug Products Q3B(R), November 2003; Impurities: Guideline for Residual Solvents, 24 December 1997; Stability Testing of New Drug Substances and Products Q1A(R2), November 2003 (http://www.fda.gov/cder/guidance/guidance.htm).
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9. Guidance for Industry, ANDAs: Impurities in Drug Substances, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, January 2005 (http://www.fda.gov/cder/guidance/6422dft.htm).
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