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Drug substances frozen

Endothermic Fusion Vaporization Sublimation Desorption Desolvation Melting of drug substances purity evaluations Evaporation of liquid or semisolid excipients Removal of frozen water during lyophilization Drying of wet granulated formulations Removal of stoichiometric water from crystalline hydrates... [Pg.394]

APPENDIX A DECISION TREE FOR DATA EVALUATION FOR RETEST PERIOD OR SHELF LIFE ESTIMATION FOR DRUG SUBSTANCES OR PRODUCTS (EXCLUDING FROZEN PRODUCTS)... [Pg.73]

Bulk drug substance storage Freeze-thawing Commercial bnlk protein drug substances are often stored as frozen solntions at -70 °C... [Pg.397]

Ikeda [3.36] presented a two stage freezing process for an antibiotic (Panipenem), which reacts with another component of the drug (Betamipron) and has therefore to be separated until its use. The first substance is filled into the vials and frozen. The precooled second substance is filled then into cooled vials and frozen. By this process, the amount of undesirable reaction product could limited to 0.5 % during a 6-months storage at 40 °C. If the two products were frozen simultaneously the amount of reaction product was 1.2%. [Pg.219]

See other pages where Drug substances frozen is mentioned: [Pg.32]    [Pg.97]    [Pg.1007]    [Pg.445]    [Pg.445]    [Pg.960]    [Pg.354]    [Pg.361]    [Pg.237]    [Pg.56]    [Pg.245]    [Pg.107]    [Pg.33]    [Pg.329]    [Pg.851]    [Pg.373]    [Pg.238]   
See also in sourсe #XX -- [ Pg.8 ]



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