Forced degradation studies to assess the stability of drugs and products

TrAC - Trends in Analytical Chemistry

Volumn 49, Issue , 2013, Pages 71-88

  Singh, Saranjit ^a   Junwal, Mahendra ^a   Modhe, Gajanan ^a   Tiwari, Harsita ^a   Kurmi, Moolchand ^a   Parashar, Neha ^a   Sidduri, Padmaja ^a  

^a NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH NIPER   (India)

Author keywords

Degradation product; Drug substance; Forced degradation; Guideline; Pharmacopoeia; Quality by Design (QbD); Regulatory agency; Stability; Stress testing; World wide regulatory requirements

Indexed keywords

CONVERGENCE OF NUMERICAL METHODS; DEGRADATION; DRUG PRODUCTS; STABILITY;

DEGRADATION PRODUCTS; DRUG SUBSTANCES; FORCED DEGRADATION; GUIDELINE; PHARMACOPOEIA; QUALITY BY DESIGNS; REGULATORY AGENCIES; REGULATORY REQUIREMENTS; STRESS TESTING;

PRODUCT DESIGN;

ATORVASTATIN; BENAZEPRIL; BIOLOGICAL PRODUCT; DRUG; EPERISONE; EXCIPIENT; GENERIC DRUG; OSELTAMIVIR; ROSUVASTATIN; THIOCOLCHICOSIDE; ZIPRASIDONE;

AEROSOL; DRUG DEGRADATION; DRUG DETERMINATION; DRUG ELUTING STENT; DRUG FORMULATION; DRUG PACKAGING; DRUG RESEARCH; DRUG SENSITIVITY; DRUG STABILITY; DRUG STRUCTURE; MEDICAL LITERATURE; METERED DOSE INHALER; PHARMACOLOGIC STRESS TESTING; PHOTOSENSITIVITY; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; TRANSDERMAL PATCH; WORLD HEALTH ORGANIZATION;

EID: 84881224460     PISSN: 01659936     EISSN: 18793142     Source Type: Journal    
DOI: 10.1016/j.trac.2013.05.006     Document Type: Review

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