b第二章 杂质检查.pptVIP

第二章 杂质检查Chapter 2 Limit Test 药物的纯度是指药物纯净的程度。它是判定药品质量优劣的一个重要指标。 The level of purity which can be attained in the manufacture of pharmaceutical products depends partly on the cost-effectiveness of the process and the purification methods available and partly on the stability of the product. Section 2. The sources of impurities 1. The manufacturing process The majority of modern pharmaceutical chemicals are prepared by organic synthesis from starting materials which are, themselves, either synthetic organic chemicals or natural products isolated from biological sources.