The same drug substance may also exist in a noncrystalline ( amorphous ) form.

同样的原料药也存在于 非晶 形态中.

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The specific identity test should be capable of distinguishing the new drug substance from related compounds.

鉴别检查应该能够区别新原料药和相关化合物.

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These limits are normally applied to related substances in the drug substance or drug product.

这些检测通常适用于原料药或制剂中有关物质的检测.

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