| Linking extractables and leachables in container/closure applications. | |
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MedLine Citation:
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PMID: 16218205 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Dennis R Jenke |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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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:
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Created Date: 2005-10-12 Completed Date: 2005-10-28 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9439538 Medline TA: PDA J Pharm Sci Technol Country: United States |
Other Details:
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Languages: eng Pagination: 265-81 Citation Subset: IM |
Affiliation:
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Technology Resources Division, Baxter Healthcare Corporation, Round Lake, IL 60073, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Drug Contamination* Drug Packaging / standards* Drug Stability Drug Storage Models, Chemical* Pharmaceutical Preparations / chemistry*, standards Solubility |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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