As the USP <231> analytical method is only suitable for control of 10 elemental impurities and not able to detect all elemental impurities, it is suggested that specific analytical method (i.e., ICP-MS) to analyze elemental impurities. Analytical procedures and method validation data should be provided in order to confirm the suitability of the analytical method. In addition, the acceptance criteria for the elemental impurities may be established based on USP <232> and ICH Q3D.

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