Category I---- Analytical procedures for quantitation of major components of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products. 第一类：对成药中原料药或活性成分（包括防腐剂）的主要组分进行定量测定的分析规程。
Category II---- Analytical procedures for determination of impurities in bulk drug substances or degradation compounds in finished pharmaceutical products. These procedures include quantitative assays and limit tests. 第二类：对成药中原料药或降解物质中杂质进行测定的分析规程。这些规程包括定量测定和限度测定。
Category III---- Analytical procedures for determination of performance characteristics (e.g., dissolution, drug release). 第三类：对工作特性（例如，溶出度、药物释放）进行测定的分析规程。
Category IV---- Identification tests. 第四类：鉴别测试。
For each category, different analytical information is needed. Listed in Table 2 are data elements that are normally required for each of these categories. 每一个类别均需要不同的分析信息。每个种类通常所需要的数据要素在表2 中列出。
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