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Related Experiment Videos

Rational limits for drug impurities.

B B Hubert1

  • 1Drugs Standards Division, United States Pharmacopeial Convention Inc., Rockville, Maryland.

Drug Safety
|January 1, 1990
PubMed
Summary
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The development of USP dissolution and drug release standards.

Pharmaceutical researchยท1990
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The United States Pharmacopeia (USP) sets standards for drug purity and volatile impurities. This paper explores the scientific basis and historical context of these USP policies, illustrating their application in drug testing.

Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Regulatory Science

Background:

  • The United States Pharmacopeia (USP) has established critical policies concerning drug substance purity.
  • Policies also address the control of organic volatile impurities in pharmaceutical products.
  • These standards are essential for ensuring drug safety and efficacy.

Purpose of the Study:

  • To provide the historical background and scientific rationale behind USP policies on drug purity.
  • To illustrate how these policies are implemented in USP monograph testing.
  • To present data on analytical methodologies used for assessing compendial article purity.

Main Methods:

  • Review of historical development of USP purity policies.
  • Analysis of the scientific principles underpinning USP impurity standards.

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  • Examination of analytical methods employed in USP monographs for purity assessment.

    • Main Results:

    • Detailed explanation of the scientific basis for USP's drug substance purity requirements.
    • Examples demonstrating the practical application of USP policies in monograph testing.
    • Overview of various analytical techniques utilized for evaluating compendial article purity.

    Conclusions:

    • USP policies on drug substance purity and organic volatile impurities are scientifically grounded.
    • USP monographs effectively translate these policies into practical quality control tests.
    • Understanding these policies and methods is crucial for pharmaceutical quality assurance.