30 Questions
What method can be used to distinguish between flocculated and non-flocculated particles?
Photo Microscopic Examination
What does a variation in color often indicate in terms of the properties of a suspension?
Poor distribution and/or differences in particle size
What is a possible reason for changes in taste of active constituents in a suspension?
Changes in particle size
What does a decrease in density of a suspension often indicate?
Entrapped air within the structure
Which method should be used for density measurements at a given temperature?
Hydrometer Archimedes principle
What property can Photo Microscopic Examination help detect in a suspension?
Particle size distribution changes
Why is it important to use the same type of filter for preparing stability samples as will be used for production-size batches?
To prevent the filter medium from absorbing ingredients from the solution.
Which characteristic is NOT typically observed during stability testing of pharmaceutical products?
Acidity
What should be observed in dry-packaged formulations reconstituted prior to use as part of their stability profile?
Moisture content and reconstitution rate
Why is it necessary to inspect both the original dry material and the reconstituted preparation of dry-packaged formulations?
To verify the stability following reconstitution.
What role does surface tension play in pharmaceutical stability testing?
Influencing gas evolution rates.
Which parameter is NOT typically evaluated during stability testing of pharmaceutical products?
Vapor contamination
How is the apparent viscosity of a suspension typically measured?
Using a Cup and Bob Viscometer
In the Cup and Bob Viscometer, how is the sample accommodated between the cup and bob?
The sample is placed in the cup and the bob is placed in the up to an appropriate height
What is one of the key purposes of using a Cone and Plate Viscometer?
To measure the shear stress produced on the cone
How is the sample sheared in a Cone and Plate Viscometer?
In the narrow gap between a stationary plate and a rotating cone
What field of science is concerned with the flow of liquids and the deformation of solids?
Rheology
What instrument is typically used to evaluate rheological properties and behavior of settling suspensions?
Brookfield viscometer
What is the purpose of purity tests for a drug substance?
To estimate the level of impurities and contaminants
Why is the leakage test employed for sterile dosage forms?
To test the package integrity
What could happen if an opening exists in a package during storage?
Interchange of package contents
Which tests estimate the quantity of an active ingredient in a drug?
Potency tests
What does a leaker test detect in an ampoule?
Incompletely sealed ampoules
What is the purpose of clarity tests for drugs?
To ensure clear solutions without visible particles
What is the purpose of the dye test mentioned in the text?
To visually detect the presence of dye in containers
Why is a surfactant or low viscosity fluid used to optimize the dye test?
To reduce the formation of bubbles during the test
Which method uses high voltage and frequency to detect residual gas in containers?
Vacuum Ionization
What is a disadvantage of the Pump Down Test mentioned in the text?
It is a slow process
In what types of containers is the dye test usually used?
Ampoules and vials
What happens if residual gas is present during the Vacuum Ionization test?
The containers glow
This quiz covers various tests and observations conducted on pharmaceutical products to assess their stability, chemical properties, and microbial presence. Topics include changes in odor, color, taste, viscosity, specific gravity, and more.
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