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1. Introduction The objective of this guideline is to recommend acceptable amounts of residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends the use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. Residual solvents in pharmaceuticals are defined here as organic volatile chemicals that are used or produced in the manufacture of active substances or excipients, or in the preparation of medicinal products. The solvents are not completely removed by practical manufacturing techniques. Appropriate selection of the solvent for the synthesis of active substance may enhance the yield, or determine characteristics such as crystal form, purity, and solubility. Therefore, the solvent may sometimes be a critical parameter in the synthetic process. This guideline does not address solvents deliberately used as excipients nor does it address solvates. However, the content of solvents in such products should be evaluated and justified. Since there is no therapeutic benefit from residual solvents, all residual solvents should be removed to the extent possible to meet product specifications, good manufacturing practices, or other quality-based requirements. Medicinal products should contain no higher levels of residual solvents than can be supported by safety data. Some solvents that are known to cause unacceptable toxicities (Class 1, Table 1) should be avoided in the production of active substances, excipients, or medicinal products unless their use can be strongly justified in a risk-benefit assessment. Some solvents associated with less severe toxicity (Class 2, Table 2) should be limited in order to protect patients from potential adverse effects. Ideally, less toxic solvents (Class 3, Table 3) should be used where practical. The complete list of solvents included in this guideline is given in Appendix 1. The lists are not exhaustive and other solvents can be used and later added to the lists. Recommended limits of Class 1 and 2 solvents or classification of solvents may change as new safety data becomes available. Supporting safety data in a marketing application for a new medicinal product containing a new solvent may be based on concepts in this guideline or the concept of qualification of impurities as expressed in the guideline for active substances (Q3A, Impurities in New Active Substances) or medicinal products (Q3B, Impurities in New Medicinal Products), or all three guidelines. |
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1.介绍 这篇指南的目的是为了病人的安全而推荐中残留溶剂的合理用量。此指南推荐使用低毒性溶剂，并且描述了一些溶剂人体能够接受的毒性水平。 药品中的残留溶剂在此定义为有机挥发性物质，用于合成活性化合物或辅料，或用于制备原料药。由于在生产过程中溶剂很难完全除去，因此合适溶剂的选择可能增加产量，决定化合物的性质如晶型、纯度和溶解度。因而溶剂有时会成为合成过程的关键因素。此指南并没有详细说明溶剂的如何使用而是评价和解释药物中溶剂的选择使用。 既然残留溶剂没有治疗效果，因此溶剂必须控制在合理水平才能达到药品规格、GMP或其他质量标准。药品中含有的残留溶剂必定不能高于安全数据的要求。一些溶剂(图1、表1)已知在活性物质、辅料和药品生产过程中能致不可接受的毒性应尽量避免使用，除非它们能够通过风险－效益评价。为了避免病人的潜在不良副反应，一些低严重毒性的溶剂(图2、表2)也应该限制使用。最理想的是使用低毒性的试剂(图3、表3)。指南中所有溶剂列表在附录1中给出。 此列表并不完全，其他溶剂会在以后陆续增补。表1和2溶剂推荐使用量或溶剂的分类可能也会随新的安全标准而改变。基于这个指南、此指南中为了活性物质(Q3A新活性物质中的杂质)或药品(Q3B新药物中的杂质)而表述的杂质评定或所有三个指南，新化合物和新溶剂在市场运作过程支持安全数据的使用。 |
2楼2008-11-07 09:46:27