Identification of drug- excipient interaction products using a stress testing assisted approach

American Pharmaceutical Review

Volumn 9, Issue 5, 2006, Pages

  Qiu, Fenghe ^a  

^a BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EXCIPIENT;

DRUG DEGRADATION; DRUG FORMULATION; DRUG HYDROLYSIS; DRUG IDENTIFICATION; DRUG IMPURITY; DRUG OXIDATION; DRUG PACKAGING; DRUG QUALITY; REVIEW;

EID: 33947120767     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. Guidance for Industry ICH Q3B(R) Impurities in New Drug Products, November 2003.
2. Steven W. Baertschi and Karen M. Alsante, Stress Testing: The Chemistry of Drug Degradation, P51, in Pharmaceutical Stress Testing, edited by Steven W. Baertschi, Taylor and Francis, 2005.
3. 3: Giovanni Boccardi, Oxidative Susceptibility Testing, P205, in Pharmaceutical Stress Testing, edited by Steven W. Baertschi, Taylor and Francis, 2005.
4. Sean X. Peng, Hyphenated HPLC-NMR and its Applications in Drug Discovery, Biomedical Chromatography, 14, 430-441, 2000.
5. Guidance for Industry ICH Q1A(R2) Stability Testing of New Drug Substances and Products, November 2003.
6. Dan W. Reynolds, Kevin L. Facchnie, June F. Mullaney, Karen M. Alsante, Todd D. hatajik, and Michael G. Motto, Available Guidance and Best Practices for Conducting Forced Degradation Studies, Pharmaceutical Technology, 26(2), 48-54, 2002.