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Related Experiment Videos

Ranitidine preparations on the Belgian market: a comparative study.

J Saevels1, K De Braekeleer, J Corthout

  • 1Service de Contrôle des Médicaments, rue Stévin 137, B-1000 Bruxelles.

Journal De Pharmacie De Belgique
|February 22, 2005
PubMed
Summary

Ranitidine tablets and granules met all quality standards in dissolution and assay tests. These pharmaceutical preparations are considered equivalent based on rigorous analytical method validation.

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry

Background:

  • Ranitidine is a widely used medication for gastrointestinal issues.
  • Ensuring pharmaceutical equivalence of generic drug products is crucial for patient safety and therapeutic efficacy.

Purpose of the Study:

  • To evaluate the pharmaceutical equivalence of ranitidine preparations.
  • To confirm compliance with established pharmacopeial standards.

Main Methods:

  • In vitro dissolution testing of ranitidine tablets and granules.
  • Assay testing to determine active ingredient content.
  • Utilized validated analytical methods according to European network of Official Medicines Control Laboratories (OMCLs) guidelines.

Main Results:

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  • All tested ranitidine preparations (tablets and granules) successfully passed in vitro dissolution tests.
  • Assay results confirmed that all products met the required ranitidine content specifications.
  • The analytical methods used were previously validated, ensuring reliable results.

    • Conclusions:

    • The evaluated ranitidine preparations demonstrate pharmaceutical equivalence.
    • Products comply with European, British, and US Pharmacopoeia standards.
    • This confirms their suitability for therapeutic use.