Pharmaceutical Impurities Quiz
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Questions and Answers

What are impurities in pharmaceutical products?

  • Unwanted chemicals that can affect drug efficacy and safety. (correct)
  • Stabilizers added to improve shelf life.
  • Essential chemicals that enhance drug potency.
  • Inactive ingredients used in drug formulation.
  • What does the International Conference on Harmonization (ICH) define as an impurity?

  • Any component intended to improve drug formulation.
  • Any component in a drug substance that is not the intended chemical entity. (correct)
  • Any active ingredient that has been modified.
  • Any component added to increase stability.
  • Why is controlling impurities critical in the pharmaceutical industry?

  • To reduce production costs.
  • To improve the visual appeal of drugs.
  • To speed up the drug approval process.
  • To ensure the efficacy and safety of drugs. (correct)
  • Which of the following statements about chemically pure compounds is true?

    <p>They are free from foreign matter.</p> Signup and view all the answers

    What might be a consequence of trace amounts of impurities in drug formulations?

    <p>Decreased drug stability.</p> Signup and view all the answers

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