Document Detail

Linking extractables and leachables in container/closure applications.
MedLine Citation:
PMID:  16218205     Owner:  NLM     Status:  MEDLINE    
Establishing a link between extractables and leachables may be necessary to understand, interpret, assess, quantify, or control the interaction between a drug product and its container/closure system. This paper considers the various factors that affect the rigor with which such a linkage is established and justified. Such an assessment considers the origin and/or genesis of the leachable or extractable, enumerates situations in which extractables/leachables linkages are useful, ties such situations to the drug product's lifecycle, defines a hierarchy of linkages based on the rigor with which the linkages are established and justified, and establishes guidelines for how to determine what kind of linkage is appropriate for certain circumstances and situations. Additionally, this paper gives several examples of linkages relevant to flexible plastic drug product containers.
Dennis R Jenke
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  PDA journal of pharmaceutical science and technology / PDA     Volume:  59     ISSN:  1079-7440     ISO Abbreviation:  PDA J Pharm Sci Technol     Publication Date:    2005 Jul-Aug
Date Detail:
Created Date:  2005-10-12     Completed Date:  2005-10-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9439538     Medline TA:  PDA J Pharm Sci Technol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  265-81     Citation Subset:  IM    
Technology Resources Division, Baxter Healthcare Corporation, Round Lake, IL 60073, USA.
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MeSH Terms
Drug Contamination*
Drug Packaging / standards*
Drug Stability
Drug Storage
Models, Chemical*
Pharmaceutical Preparations / chemistry*,  standards
Reg. No./Substance:
0/Pharmaceutical Preparations

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