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Index
»
QUALITY CONTROL 2 LEC
»
Compendial Requirements for Parenterals
»
Level 4
level: Level 4
Questions and Answers List
level questions: Level 4
Question
Answer
the most important and Absolutely Essential characteristics of Parenteral products. means complete absence of all viable Microorganism.
Sterility
it is an traditional sterility test method which involves a direct inoculation of required volume of a sample in two tests tube containing a culture medium
Direct Transfer method
It is official in U.S.P. 1970. involves filtration of Sample through membrane filters of porosity 0.22 micron and Diameter 47mm with hydrophobic characteristics.
Membrane Filtration method
Since these dosage forms are constituted at the time of use by the health care practitioner, tests and standards pertaining to the solution as constituted for administration are not included in the individual monographs on __
sterile dry solids or liquid concentrates.
Constitute the solution as directed in the labeling supplied by the manufacturer for the sterile dry dosage form
Completeness and Clarity of Solution
Constitute the solution as directed in the labeling supplied by the manufacturer for the sterile dry dosage form: the solution is essentially free from particles of foreign matter that can be observed on visual inspection.
Particulate Matter