几个英文单词的准确翻译，谢谢
DRUG SUBSTANCEGeneral Information
Nomenclature
Structure
General Properties
Manufacture
Manufacturer Information
[color=red]Characterization[/color]
Elucidation of structure and other characteristics
Impurities
Control of drug substance
[color=red]Specifications [/color]
Analytical Procedures
Validation of Analytical Procedures
Batch Analysis
Reference Standard or Materials
Container Closure System
Material Safety Data Sheet
Stability
Stability Summary and Conclusions
Post Approval Stability Protocol
Stability Data
请高手们帮忙看一下，红色部分的单词的准确译文
谢谢！
Specifications应该是质量标准，对么？ Characterization:特性，鉴别，特征等
Specifications：质量标准（说明书：package insert）
你能给一个具体的全文吗？这样才能翻译更加准确 谢谢wuhuiwolf
Glossary of Terms
1.0 INTRODUCTION
2.1.S DRUG SUBSTANCE
2.1.S.1 General Information
2.1.S.1.1 Nomenclature
2.1.S.1.2 Structure
2.1.S.1.3 General Properties
2.1.S.2 Manufacture
2.1.S.2.1 Manufacturer
2.1.S.2.2 Description of Manufacturing Process and Process Controls
Process A
Process B
2.1.S.2.3 Control of Materials
2.1.S.2.4 Control of Critical Steps and Intermediates
2.1.S.2.5 Process Validation and/or Evaluation
2.1.S.2.6 Manufacturing Process Development
2.1.S.3 Characterisation
2.1.S.3.1 Elucidation of Structure and Other Characteristics
2.1.S.3.2 Impurities
2.1.S.4 Control of Drug Substance
2.1.S.4.1 Specifications
2.1.S.4.2 Analytical Procedures
2.1.S.4.3 Validation of Analytical Procedures
2.1.S.4.4 Batch Analyses
2.1.S.4.5 Justification of Specification
这是某种药品的INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER前面的目录部分，我查了一下，觉得Specifications应该就是国内所说的质量标准，但是对于Characterisation却始终没有找到合适的词汇，而这一单词在以后的正文当中多次（或者以动词形式）出现，比如：
Both reference standards have undergone complete specification testing and have been well characterized.
恳请大家帮忙！ Specifications:鉴别
Characterisation：性状。
Both reference standards have undergone complete specification testing and have been well characterized：意思是：两种标准品都要经过完整的鉴别试验和性状检查。
应该没有错的。 Specifications:质量标准
Characterisation：性状(物理、化学的） Characterization 鉴定
Specifications 规范
英汉医学词典 it is the content of DMF; you may check the file BELOW; it is prepared by somebody else:
3.2.S.1 General Information 一般信息
3.2.S.1.1 Nomenclature 化学名
3.2.S.1.2 Structure 结构式
3.2.S.1.3 General Properties 物理特性，溶解性，多形性，熔点，药理学，药代动力学，毒理学数据等等
3.2.S.2 Manufacture 生产
3.2.S.2.1 Manufacturer生产厂家
3.2.S.2.2 Description of Manufacturing Process and Process Controls
生产过程及工艺控制
3.2.S.2.3 Control of Materials 原料控制
3.2.S.2.3.1 Raw materials: specification and analytical method
原料规格和检验方法
3.2.S.2.3.2 Process water: specifications and analytical method
工艺用水和检验方法
3.2.S.2.4 Controls of Critical Steps and Intermediates
关键步骤和中间体控制
3.2.S.2.4.1 In – process Specifications 中间控制规格
3.2.S.2.4.2 In – process control method 中间控制方法
3.2.S.2.5 Process Validation and/or Evaluation 工艺验证
3.2.S.3 Characterization 产品特性
3.2.S.3.1 Elucidation of Structure and other Characteristics
结构确证和其它特性
3.2.S.3.2 Impurities杂质
3.2.S.3.2.1 Related substances 相关物质
3.2.S.3.2.2 Inorganic impurities有机杂质
3.2.S.3.2.3 Solvents溶剂
3.2.S.3.2.4 Summary Method Validation for Residue solvent test in Spiramycin
溶剂残留方法验证
3.2.S.4 Control of Drug Substance 成品控制
3.2.S.4.1 Batch system 批号系统
3.2.S.4.2 Specification 规格
3.2.S.4.2 Analytical Procedures 检验方法
3.2.S.4.3 Batch Analyses批检验结果（3批）
3.2.S.5 Reference Standards or Materials 对照品
3.2.S.6 Container Closure System 包装物
3.2.S.7 Stability 稳定性 Characterization 特性
Specifications 规格 弄清楚了！
specification 质量标准
characterizition 表征 特性
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