Leachables evaluation for bulk drug substance

PDA Journal of Pharmaceutical Science and Technology

Volumn 63, Issue 2, 2009, Pages 168-183

  Tsui, Victor ^a   Somma, Maria S ^b   Zitzner, Linda A ^b  

^a VaxGen Inc   (United States)

^b APPLIED MATERIALS INC   (United States)

Author keywords

Bulk drug substance; Disposable; Extractable; Final drug product; Formaldehyde; International Conference on Harmonisation; Leachable; Risk evaluation; Silicon; Volatile organic compounds

Indexed keywords

ANION; BULK DRUG SUBSTANCE; CATION; DRUG; FORMALDEHYDE; ORGANIC COMPOUND; RESIN; SILICON; TRACE METAL; UNCLASSIFIED DRUG; VOLATILE ORGANIC COMPOUND; WATER; ION;

ARTICLE; CONTROLLED STUDY; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; LEACHING; RISK ASSESSMENT; DRUG CONTAMINATION; PHARMACEUTICS;

DRUG CONTAMINATION; FORMALDEHYDE; IONS; ORGANIC CHEMICALS; SILICON; TECHNOLOGY, PHARMACEUTICAL; VOLATILE ORGANIC COMPOUNDS;

EID: 68349104991     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (3)

1. Biopharmaceutical Process Extractables Core Team, Evaluation of extractables from product-control surfaces. BioPharm Int. 2002, December, 22-34.
2. International Committee on Harmonisation (ICH); Food and Drug Administration. Guidance for Industry, Q3C "Impurities: Residual Solvents", December 1997.
3. The United States Pharmacopeia. 〈88〉 Biological Reactivity Tests, In Vivo, USP30-NF25, 20852; United States Pharmacopeial Convention, Inc.: Rockville, MD, 2007.