Document Detail

Methodology for in-process determination of residual water in freeze-dried products.
MedLine Citation:
PMID:  1592164     Owner:  NLM     Status:  MEDLINE    
The integrity of freeze-dried biological products after reconstitution, as well as their stability during storage, is often more sensitive to small variations in residual moisture level than traditional low molecular weight drugs. Susceptibility to over-drying has also been documented for biological products. This places additional demands on the quality of in-process monitoring to achieve the desired level of residual water. This discussion is a critical overview of methodology for in-process moisture determination, including product temperature measurement, comparative pressure measurement, pressure rise, and residual gas analysis. Advantages and limitations of these methods are discussed.
S L Nail; W Johnson
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Publication Detail:
Type:  Comparative Study; Journal Article; Review    
Journal Detail:
Title:  Developments in biological standardization     Volume:  74     ISSN:  0301-5149     ISO Abbreviation:  Dev. Biol. Stand.     Publication Date:  1992  
Date Detail:
Created Date:  1992-07-02     Completed Date:  1992-07-02     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0427140     Medline TA:  Dev Biol Stand     Country:  SWITZERLAND    
Other Details:
Languages:  eng     Pagination:  137-50; dicussion 150-1     Citation Subset:  IM    
Department of Industrial and Physical Pharmacy, Purdue University, West Lafayette, IN 47907.
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MeSH Terms
Biological Products / isolation & purification*
Freeze Drying / instrumentation,  methods*
Gases / analysis
Water / analysis
Reg. No./Substance:
0/Biological Products; 0/Gases; 7732-18-5/Water

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