当时间有限时，这对国外无菌原料药的生产厂家特别重要。

This is particularly important for the foreign sterile bulk drug substance manufacturer where time is limited.

在原料药生产工业，尤其是非肠道用药的原料，在水系统中通常用到超滤和反渗透系统。

In the bulk drug substance industry, particularly for parenteral grade substances, it is common to see Ultrafiltration and Reverse Osmosis systems in use in water systems.

该公司是多用途原料药制药工厂。

This firm was a multi-use bulk pharmaceutical facility.

对原料药工艺所作的预验证的结果，必须在用该原料药制成的制剂产品销售前完成。

Prospective validation for an API process should be completed before the commercial distribution of the final drug product manufactured from that API.

鉴别检查应该能够区别新原料药和相关化合物.

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

本文件适用于人用药品（医疗用品）所含原料药的生产。

This guidance applies to the manufacture of APIs for use in human drug (medicinal) products.

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.

属医药业的制药行业,为各抗癌原料药生产厂家提供最基本的原料.

Raw materials for pharmaceutical factories which provide medicines fighting against cancer.

齐鲁安替比奥制药有限公司专业生产头孢菌素原料药,年生产能力600吨.

Qilu Antibioticos is specialized in Cephalosporin bulk production with annual output of 600 tons.

原料药样品必须保存在与市场上销售的原料药贮存的容器包装系统相当或更具保护性的容器包装系统内。

API Sample containers must be stored in the same Packaging System in which the API is stored or in one that is equivalent to or more protective than the marketed Packaging System.