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Research ArticleRESEARCH

Impact of Different Elastomer Formulations on Moisture Permeation through Stoppers Used for Lyophilized Products Stored under Humid Conditions

Hitoshi Sasaki, Jun Kikuchi, Terutoshi Maeda and Hitoshi Kuboniwa
PDA Journal of Pharmaceutical Science and Technology January 2010, 64 (1) 63-70;
Hitoshi Sasaki
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Jun Kikuchi
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Terutoshi Maeda
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Hitoshi Kuboniwa
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References

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    1. Pikal M. J.,
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    Moisture transfer from stopper to product and resulting stability implications. Dev. Biol. Stand. 1992, 74, 165– 177.
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    Water permeability of elastomers. J. Biol. Stand. 1977, 5 ( 2), 111– 119.
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    1. Donovan P. D.,
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    Effect of stopper processing conditions on moisture content and ramifications for lyophilized products: comparison of “low” and “high” moisture uptake stoppers. PDA J. Pharm. Sci. Technol. 2007, 61 ( 1), 51– 58.
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    1. Earle J. P.,
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    The effects of stopper drying on moisture levels of Haemophilus influenzae conjugate vaccine. Dev. Biol. Stand. 1992, 74, 203– 210.
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    1. Templeton A. C.,
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    Determination of the moisture content of bromobutyl rubber stoppers as a function of processing: implications for the stability of lyophilized products. PDA J. Pharm. Sci. Technol. 2003, 57 ( 2), 75– 87.
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    ICH Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision); International Conference on Harmonisation (ICH), 2003.
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PDA Journal of Pharmaceutical Science and Technology: 64 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 1
January/February 2010
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Impact of Different Elastomer Formulations on Moisture Permeation through Stoppers Used for Lyophilized Products Stored under Humid Conditions
Hitoshi Sasaki, Jun Kikuchi, Terutoshi Maeda, Hitoshi Kuboniwa
PDA Journal of Pharmaceutical Science and Technology Jan 2010, 64 (1) 63-70;

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Impact of Different Elastomer Formulations on Moisture Permeation through Stoppers Used for Lyophilized Products Stored under Humid Conditions
Hitoshi Sasaki, Jun Kikuchi, Terutoshi Maeda, Hitoshi Kuboniwa
PDA Journal of Pharmaceutical Science and Technology Jan 2010, 64 (1) 63-70;
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