The role of degradant profiling in active pharmaceutical ingredients and drug products

Advanced Drug Delivery Reviews

Volumn 59, Issue 1, 2007, Pages 29-37

  Alsante, Karen M ^a   Ando, Akemi ^a   Brown, Roland ^b   Ensing, Janice ^a   Hatajik, Todd D ^a   Kong, Wei ^a   Tsuda, Yoshiko ^a  

^a PFIZER INC   (United States)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Acid base hydrolysis; CAMEO; Forced degradation; Humidity; Oxidation; Stability indicating; Thermal

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENT (API); FORCED DEGRADATION; STABILITY INDICATING;

ATMOSPHERIC HUMIDITY; DEGRADATION; HYDROLYSIS; INFORMATION RETRIEVAL; OXIDATION; PUBLISHING; REGULATORY COMPLIANCE;

DRUG PRODUCTS;

ACID; BASE;

DATA BASE; DEGRADATION; DRUG IMPURITY; DRUG LEGISLATION; DRUG MARKETING; DRUG STABILITY; HUMIDITY; HYDROLYSIS; OXIDATION; PHOTOLYSIS; PHYSICAL CHEMISTRY; PREDICTION; PRIORITY JOURNAL; REVIEW; SOLID STATE; STEREOCHEMISTRY; TEMPERATURE SENSITIVITY; THERMOSTABILITY;

ALGORITHMS; DRUG CONTAMINATION; DRUG STABILITY; FORECASTING; PHARMACEUTICAL PREPARATIONS;

EID: 33846785326     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.addr.2006.10.006     Document Type: Review

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