Pharmaceutical Product Testing Methods
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Questions and Answers

What method can be used to distinguish between flocculated and non-flocculated particles?

  • Titration
  • Photo Microscopic Examination (correct)
  • Chromatography
  • Gravimetric analysis
  • What does a variation in color often indicate in terms of the properties of a suspension?

  • Uniform particle size
  • Improved particle distribution
  • Poor distribution and/or differences in particle size (correct)
  • Increased stability
  • What is a possible reason for changes in taste of active constituents in a suspension?

  • Crystal shape consistency
  • Uniform particle size
  • Changes in particle size (correct)
  • Variation in odor
  • What does a decrease in density of a suspension often indicate?

    <p>Entrapped air within the structure</p> Signup and view all the answers

    Which method should be used for density measurements at a given temperature?

    <p>Hydrometer Archimedes principle</p> Signup and view all the answers

    What property can Photo Microscopic Examination help detect in a suspension?

    <p>Particle size distribution changes</p> Signup and view all the answers

    Why is it important to use the same type of filter for preparing stability samples as will be used for production-size batches?

    <p>To prevent the filter medium from absorbing ingredients from the solution.</p> Signup and view all the answers

    Which characteristic is NOT typically observed during stability testing of pharmaceutical products?

    <p>Acidity</p> Signup and view all the answers

    What should be observed in dry-packaged formulations reconstituted prior to use as part of their stability profile?

    <p>Moisture content and reconstitution rate</p> Signup and view all the answers

    Why is it necessary to inspect both the original dry material and the reconstituted preparation of dry-packaged formulations?

    <p>To verify the stability following reconstitution.</p> Signup and view all the answers

    What role does surface tension play in pharmaceutical stability testing?

    <p>Influencing gas evolution rates.</p> Signup and view all the answers

    Which parameter is NOT typically evaluated during stability testing of pharmaceutical products?

    <p>Vapor contamination</p> Signup and view all the answers

    How is the apparent viscosity of a suspension typically measured?

    <p>Using a Cup and Bob Viscometer</p> Signup and view all the answers

    In the Cup and Bob Viscometer, how is the sample accommodated between the cup and bob?

    <p>The sample is placed in the cup and the bob is placed in the up to an appropriate height</p> Signup and view all the answers

    What is one of the key purposes of using a Cone and Plate Viscometer?

    <p>To measure the shear stress produced on the cone</p> Signup and view all the answers

    How is the sample sheared in a Cone and Plate Viscometer?

    <p>In the narrow gap between a stationary plate and a rotating cone</p> Signup and view all the answers

    What field of science is concerned with the flow of liquids and the deformation of solids?

    <p>Rheology</p> Signup and view all the answers

    What instrument is typically used to evaluate rheological properties and behavior of settling suspensions?

    <p>Brookfield viscometer</p> Signup and view all the answers

    What is the purpose of purity tests for a drug substance?

    <p>To estimate the level of impurities and contaminants</p> Signup and view all the answers

    Why is the leakage test employed for sterile dosage forms?

    <p>To test the package integrity</p> Signup and view all the answers

    What could happen if an opening exists in a package during storage?

    <p>Interchange of package contents</p> Signup and view all the answers

    Which tests estimate the quantity of an active ingredient in a drug?

    <p>Potency tests</p> Signup and view all the answers

    What does a leaker test detect in an ampoule?

    <p>Incompletely sealed ampoules</p> Signup and view all the answers

    What is the purpose of clarity tests for drugs?

    <p>To ensure clear solutions without visible particles</p> Signup and view all the answers

    What is the purpose of the dye test mentioned in the text?

    <p>To visually detect the presence of dye in containers</p> Signup and view all the answers

    Why is a surfactant or low viscosity fluid used to optimize the dye test?

    <p>To reduce the formation of bubbles during the test</p> Signup and view all the answers

    Which method uses high voltage and frequency to detect residual gas in containers?

    <p>Vacuum Ionization</p> Signup and view all the answers

    What is a disadvantage of the Pump Down Test mentioned in the text?

    <p>It is a slow process</p> Signup and view all the answers

    In what types of containers is the dye test usually used?

    <p>Ampoules and vials</p> Signup and view all the answers

    What happens if residual gas is present during the Vacuum Ionization test?

    <p>The containers glow</p> Signup and view all the answers

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