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[Studies on residue on ignition test in JP].
Teruyuki Kitagawa1, Yumi Umeyama, Kaoru Hirata
1Fujisawa Pharmaceutical Co., Ltd., Analytical Research Laboratories, 2-1-6, Kashima, Yodogawa-ku, Osaka 532-8514, Japan. teruyuki_kitagawa@po.fujisawa.co.jp
Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan
|February 7, 2002
Summary
The Residue on Ignition Test quantifies inorganic impurities or components in organic substances. Validation studies established a 0.50 mg quantitation limit, crucial for quality control in drug development.
Area of Science:
- Pharmaceutical Analysis
- Analytical Chemistry
- Quality Control
Context:
- The Japanese Pharmacopeia's Residue on Ignition Test measures non-volatile inorganic residues after sample ignition.
- This test is vital for assessing inorganic impurities or components in organic substances.
- It is widely applied in quality control for drug substances, intermediates, and starting materials during drug development.
Purpose:
- To validate the Residue on Ignition Test for quality control applications in pharmaceutical development.
- To determine the quantitation limit for impurity analysis.
- To assess the trueness and precision of the method for determining inorganic components.
Summary:
- Validation studies defined the quantitation limit at approximately 0.50 mg.
- Sample size determination should consider this limit and desired quantitation or specification limits.
- The test method demonstrates good trueness and precision for determining alkaline salts of organic compounds when performed carefully.
Impact:
- Provides critical data for ensuring the quality and safety of pharmaceutical products.
- Establishes a reliable analytical method for inorganic content determination in drug development.
- Guides appropriate sample handling and test execution for accurate results.