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 (B)</p> Signup and view all the answers

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

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

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

<p>Particle size distribution changes (C)</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. (A)</p> Signup and view all the answers

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

<p>Acidity (B)</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 (D)</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. (C)</p> Signup and view all the answers

What role does surface tension play in pharmaceutical stability testing?

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

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

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

How is the apparent viscosity of a suspension typically measured?

<p>Using a Cup and Bob Viscometer (B)</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 (B)</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 (C)</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 (D)</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 (C)</p> Signup and view all the answers

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

<p>Brookfield viscometer (B)</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 (A)</p> Signup and view all the answers

Why is the leakage test employed for sterile dosage forms?

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

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

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

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

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

What does a leaker test detect in an ampoule?

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

What is the purpose of clarity tests for drugs?

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

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

<p>Vacuum Ionization (A)</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 (B)</p> Signup and view all the answers

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

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

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

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

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