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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

Applications of Headspace Moisture Analysis for Investigating the Water Dynamics within a Sealed Vial Containing Freeze-dried Material

Isobel Ann Cook and Kevin Richard Ward
PDA Journal of Pharmaceutical Science and Technology January 2011, 65 (1) 2-11;
Isobel Ann Cook
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Kevin Richard Ward
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References

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    Thermogravimetry and vapour pressure moisture. Applications to determination of residual moisture in BCG vaccine. Journal of Thermal Analysis and Calorimetry 2006, 83 (1), 31–33.
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    Using laser based headspace moisture analysis for rapid non-destructive moisture determination of sterile freeze-dried product. White paper, 2009.
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    Application of frequency-modulated spectroscopy in vacuum seal integrity of lyophilized biological products. PDA J. Pharm. Sci. Technol. 2004, 58 (2), 106–115.
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    1. Sasaki H.,
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    Impact of different elastomer formulations on moisture permeation through stoppers used for lyophilized products stored under humid conditions. PDA J. Pharm. Sci. Technol. 2010, 64 (1), 63–70.
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    1. Mahajan R.,
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    A novel, non-destructive approach for measuring moisture activity in pharmaceutical samples. J. Pharmaceutical Technology, Data and Review 2005, 83.
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    1. Donovan P. D.,
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    3. Burton M. 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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    Time-dependence of pressure in lyophilisation vials. PDA J. Pharm. Sci. Technol. 1994, 48 (4), 189–196.
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    Moisture sorption behaviour of selected bulking agents used in lyophilized products. PDA J. Pharm. Sci. Technol. 2000, 54 (2), 144–149.
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    1. Rambhatla S.,
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    Heat and mass transfer scale-up issues during freeze-drying, I: Atypical radiation and edge vial effect. AAPS PharmSciTech 2003, 4 (2), article 14.
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    1. Izutsu K.,
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    Increased stabilizing effects of amphiphilic excipients on freeze-drying of lactate dehydrogenase (LDH) by dispersion into sugar matrices. Pharm. Res. 1995, 12 (6), 838–843.
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    1. Franks F.,
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    Freeze-drying of Pharmaceuticals and Biopharmaceuticals, 1st ed.; The Royal Society of Chemistry: Cambridge, 2007; p 125.
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PDA Journal of Pharmaceutical Science and Technology: 65 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 1
January/February 2011
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Applications of Headspace Moisture Analysis for Investigating the Water Dynamics within a Sealed Vial Containing Freeze-dried Material
Isobel Ann Cook, Kevin Richard Ward
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 2-11;

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Applications of Headspace Moisture Analysis for Investigating the Water Dynamics within a Sealed Vial Containing Freeze-dried Material
Isobel Ann Cook, Kevin Richard Ward
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 2-11;
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Cited By...

  • The Application of Noninvasive Headspace Analysis to Media Fill Inspection
  • Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at -80 {degrees}C
  • Headspace Moisture Mapping and the Information That Can Be Gained about Freeze-Dried Materials and Processes
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