元素杂质在最终原料药中的限度会根据CE P持有人实施的情况包括在CEP上。
Limits for elemental impurities in the final substance, as implemented by the CEP holder will be included on the CEP.
原料药的粒度分布和表面面积可能会影响药品的溶出度与生物利用度。
Particle size distribution and surface area of the drug substance may affect the dissolution and bioavailability of the drug product.
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