Critical factors of the vacuum-oven technique which influence the estimation of moisture in veterinary biologics.
When striving toward standardization of lyophilized products, it is often difficult to correlate biological characteristics and residual-moisture content because of the great variety of assay procedures being used to estimate residual moisture. Even when moisture assays are performed according to the same general assay procedure, there are often subtle differences that cause large variations in results. Critical factors of the vacuum-oven technique such as: homogeneity and number of samples, size of samples, moisture adsorption of dry weighing dishes, efficacy of disiccator jars, influence of ambient conditions, controlling time-sequence of the test, tolerances of the test, etc. are discussed and data presented to demonstrate how some of these factors can strongly influence the results of the assay. The validity of the assay and the subsequent judgement about the quality of the final product are greatly dependent upon how well these factors are controlled.
D006516:Adenoviruses, Canine / Q000276:immunology; D001688:Biological Products / Q000032:analysis* / Q000592:standards; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D004217:Distemper Virus, Canine / Q000276:immunology; D005612:Freeze Drying; D014618:Vacuum; D014730:Veterinary Medicine; D014765:Viral Vaccines / Q000032:analysis; D014867:Water / Q000032:analysis*
D001688:Biological Products; D014765:Viral Vaccines; D014867:Water