Podcast
Questions and Answers
What are impurities in pharmaceutical products?
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?
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?
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?
Which of the following statements about chemically pure compounds is true?
What might be a consequence of trace amounts of impurities in drug formulations?
What might be a consequence of trace amounts of impurities in drug formulations?
Flashcards
Impurities in drugs
Impurities in drugs
Unwanted chemicals in pharmaceutical ingredients.
Impact of impurities
Impact of impurities
Can reduce a drug's effectiveness and safety.
ICH guidelines
ICH guidelines
Rules for managing drug impurities.
Impurity definition (ICH)
Impurity definition (ICH)
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Chemically pure compound
Chemically pure compound
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