| Determination of the moisture content of bromobutyl rubber stoppers as a function of processing: implications for the stability of lyophilized products. | |
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MedLine Citation:
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PMID: 14674509 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The purpose of the present study is to apply and contrast several analytical techniques to understand the change in moisture content of 20 mm diameter bromobutyl rubber stoppers as a function of typical stopper processing conditions. Three separate methods were examined and Karl-Fischer titration and techniques based on capacitance measurements at a thin-film sensor were found to provide comparable results. Stopper moisture levels were examined in stoppers: (i) as received from the manufacturer, (ii) following steam sterilization, (iii) as a function of various drying cycles, and (iv) during simulated hold conditions prior to use. Finally, the transfer of moisture from stopper to an actual product is examined on storage and general agreement observed between stopper drying conditions and cake moisture levels. |
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Authors:
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Allen C Templeton; Jiri Placek; Hui Xu; Rajiv Mahajan; William A Hunke; Robert A Reed |
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Publication Detail:
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Type: Comparative Study; Journal Article |
Journal Detail:
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Title: PDA journal of pharmaceutical science and technology / PDA Volume: 57 ISSN: 1079-7440 ISO Abbreviation: PDA J Pharm Sci Technol Publication Date: 2003 Mar-Apr |
Date Detail:
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Created Date: 2003-12-16 Completed Date: 2004-02-23 Revised Date: 2008-11-21 |
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: 75-87 Citation Subset: IM |
Affiliation:
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Pharmaceutical Analysis and Control, Merck Research Laboratories, West Point, PA 19486, USA. allen_templeton@merck.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Elastomers Freeze Drying / methods Hot Temperature Pharmaceutical Preparations / analysis Rubber / chemistry* Titrimetry / methods Water / analysis* |
| Chemical | |
Reg. No./Substance:
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0/Elastomers; 0/Pharmaceutical Preparations; 7732-18-5/Water; 9006-04-6/Rubber; 9010-85-9/butyl rubber |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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