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Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
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[Study on the proficiency testing program of pharmaceutical preparation analysis].

Lin-Bo Wang1, Mei-Cheng Yang, Zhu-Kang Chen

  • 1Shanghai Institute for Food and Drug Control, Shanghai 201203, China.

Yao Xue Xue Bao = Acta Pharmaceutica Sinica
|August 25, 2012
PubMed
Summary
This summary is machine-generated.

This international proficiency testing program assessed pharmaceutical analysis capabilities across 18 economies. Most participating laboratories demonstrated satisfactory performance in analyzing hydrochlorothiazide and captopril preparations.

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Area of Science:

  • Pharmaceutical Analysis
  • Laboratory Proficiency Testing
  • Quality Control

Context:

  • International collaboration involving 18 countries and economies.
  • Proficiency testing program authorized by Asia Pacific Laboratory Accreditation Cooperation (APLAC).
  • Organized by Shanghai Institute for Food and Drug Control (SIFDC) and China National Accreditation Service for Conformity Assessment (CNAS).

Purpose:

  • To evaluate the pharmaceutical preparation analysis capacity of laboratories.
  • To assess the homogeneity and stability of proficiency testing samples using the 0.3sigma test.
  • To benchmark laboratory performance in pharmaceutical analysis.

Summary:

  • 33 laboratories participated, submitting results for hydrochlorothiazide and captopril analysis.
  • Laboratory results were assessed using Z-scores, with performance evaluated by robust statistics.
  • 24 laboratories achieved satisfactory results, while 9 reported questionable or unsatisfactory results.

Impact:

  • Identifies strengths and weaknesses in global pharmaceutical analysis capabilities.
  • Provides data for improving laboratory quality and accreditation standards.
  • Contributes to ensuring the quality and safety of pharmaceutical preparations worldwide.