Forced degradation as an integral part of HPLC stability-indicating method development

Drug Delivery Technology

Volumn 10, Issue 5, 2010, Pages 56-59

  Ngwa, George ^a,b  

^a Particle Sciences Inc   (United States)

^b ORASURE TECHNOLOGIES INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EXCIPIENT;

DRUG DEGRADATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG PACKAGING; DRUG SCREENING; DRUG SPECIFICITY; DRUG STABILITY; DRUG STORAGE; DRUG SYNTHESIS; EXPERIMENTAL DESIGN; FORCED DEGRADATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HYDROLYSIS; HYDROXYLATION; OXIDATION; PHOTOLYSIS; QUANTITATIVE ANALYSIS; SHORT SURVEY; SOLID STATE; STABILITY INDICATING METHOD; THERMAL DIFFUSION; VALIDATION STUDY;

EID: 77953274805     PISSN: 15372898     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Short Survey

References (9)

1. FDA Guidance for Industry. Analytical Procedures and Methods Validation (draft guidance), August 2000.
2. ICH guidelines Q1A (R2). Stability Testing of New Drug Substances and Products (revision 2), November 2003.
3. Reynolds DW, Facchine KL, Mullaney JF, Alsante KM, Hatajik TD, Motto MG. Available guidance and best practices for conducting forced degradation studies. Pharm Tech. 2002:48-56.
4. FDA Guidance for Industry. INDs for Phase II and III Studies - Chemistry, Manufacturing, and Controls Information. May 2003.
5. Kats M. Forced degradation studies: regulatory considerations and implementation. BioPharm Int. July 2005.
6. Szepesi G. Selection of high-performance liquid chromatographic methods in pharmaceutical analysis. J Chromatogr. 1989;464:265-278.
7. Carr GP, Wahlich JC. A practical approach to method validation in pharmaceutical analysis. J Pharm Biomed Anal. 1990;86:613-618.
8. Jenke DR. Chromatographic method validation: a review of common practices and procedures II. J Liq Chromat. 1996;19:737-757.
9. Banker GS, Rhodes CT. Modern Pharmaceutics - Fourth Edition. Revised and Expanded. 2002:152.