We are a manufacturer of active pharmaceutical ingredients(API) and testing the elemental impurities as per ICHQ3D guide line.In ICHQ3D there is list of 24 elements they have to be tested with some recommendation and apart from that if any elements is used as a catalyst or as a raw material has to be also tested.If we talk about Calcium ,Sodium and Phosphorus they are abandoned in nature and are being in primary stages of manufacturing process.
No, they are not in the list in ICH Q3D. In addition the requirement is for the drug product at the NDA stage. Some buyers request that your API be tested for the 24 elemental impurities and is a good practice for business. Also, it they are controlled at the API (and excipient) stage, it could be included in the justification not to control it for the drug product. The sponsor of the NDA is responsible to provide information of the elemental impurities and a justification for the levels outside the ICH limits, Also, if some metal ions like Ca2+ could change the performance of the drug product it has to have specification limits, but not as per ICH Q3D.
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