Extractables and leachables: A biopharmaceutical perspective

American Pharmaceutical Review

Volumn 8, Issue 3, 2005, Pages 24-29

  Green, Stuart ^a  

^a CENTOCOR INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

KETONE; POLITEF; POLYETHER; POLYETHYLENE; SILICONE;

ANALYTIC METHOD; DRUG IDENTIFICATION; DRUG MANUFACTURE; DRUG PURITY; DRUG QUALITY; DRUG SAFETY; REVIEW; TEMPERATURE; TIME; VALIDATION PROCESS;

EID: 33745677538     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (2)

1. Code of Federal Regulations, Food and Drugs Title 21, Part 211.65 (U.S. Government Printing Office, Washington, DC, revised 1 April 2004).
2. USP 26-NF 21 (2003) sections 〈87〉 Biological Reactivity Tests In-Vitro, 〈88〉 Biological Reactivity Tests In-Vivo, 〈661〉 Physicochemical Tests.