[Procedure Validation of Elemental Impurities and Observation in Crude Drugs and Kampo Extracts]
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View abstract on PubMed
Summary
This summary is machine-generated.The Japanese Pharmacopoeia
Area Of Science
- Pharmacology and Toxicology
- Analytical Chemistry
Background
- The 18th edition of the Japanese Pharmacopoeia introduced General Tests 〈2.66〉 for Elemental Impurities.
- This shift moves from colorimetric methods to instrumental analyses for individual element control, considering toxicological risks.
Purpose Of The Study
- To evaluate the applicability of General Tests 〈2.66〉 to crude drugs and Kampo Extracts.
- To further understand the risks associated with elemental impurities in these herbal products.
Main Methods
- Quantification of seven Class 1 and 2A elemental impurities (Cd, Pb, As, Hg, Co, V, Ni) based on 〈2.66〉 principles.
- Analysis of ten crude drugs (roots and rhizomes) and twelve Kampo Extracts using validated analytical methods.
Main Results
- The analytical procedures in General Tests 〈2.66〉 are applicable to the tested herbal medicines and Kampo Extracts.
- Controlling elemental concentrations to permitted levels is challenging for crude drugs due to administration routes.
Conclusions
- Elemental impurities in herbal medicines and Kampo Extracts can be assessed using the Japanese Pharmacopoeia's 〈2.66〉 methods.
- Individual control of elements in Official Monographs, considering measured contents, is recommended over fixed permitted concentrations for crude drugs.
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