滴定液管理规程要点.doc

1、目的 PURPOSE 建立滴定液管理规程，使滴定液配制、标定、使用规范化。 Establish the management regulation for volumetric solutions to regulate the preparation, standardization and use of volumetric solutions. 2、适用范围 SCOPE 滴定液Volumetric Solutions 3、依据及参考文件 REFERENCES 3.1《中华人民共和国国家标准》GB 601－88 GB 601－88 of National Standards of Peoples Republic of China 3.2《中国药品检验标准操作规范》2010年版 Standard Operation Norm of Chinas Drug Inspection, 2010 3.3《中华人民共和国药典》2010年版附录XVF Appendix XVF of Pharmacopoeia of Peoples Republic of China, 2010 3.4 SOP-QC-020《溶液配制标准管理规程》“SOP for Management of Solution Preparation” 3.5 SOP-QC-001《QC实验室管理规程》“SOP for QC Laboratory Management” 3.6《中华人民共和国药典》2010年版增补本 First Supplemental Amended Volume of Pharmacopoeia of Peoples Republic of China, 2010 4、职责 RESPONSIBILITIES 4.1滴定液管理员Volumetric Solutions Administrator： 4.1.1根据使用量及库存量，及时配制、标定滴定液。 Prepare and standardize volumetric solutions according to usage and inventory timely; 4.1.2负责过有效期滴定液销毁。 Responsible for destruction of invalid volumetric solutions 4.2 QC检验员QC Analyst： 按照此操作规程执行。 Implement this SOP 4.3 QC经理QC Manager： 保证检验员按照此文件的要求执行。 Assure the analyst implement this SOP 内容 CONTENT 5.1简述Resume 5.1.1滴定液系指在容量分析中用于滴定被测物质含量的标准溶液，具有准确的浓度 (取4位有效数字)。 Volumetric solutions are the standard solutions with precise concentration (with 4 significant digits) which are used to titrate measured matter content in capacity analysis. 5.1.2滴定液的浓度以“mol/L”表示，其基本单位应根据药典规定。 The concentration of the titrate is expressed by ‘mol/L’, its basic unit should be based on the regulations of Chinese Pharmacopoeia. 5.1.3滴定液的浓度值以其名义值之比，称为“F”值，常用于容量分析的计算。 The ‘F’ value often used in the calculation of capacity analysis is defined as the ratio of the concentration of volumetric solutions and its nominal value. 5.2仪器与用具Instruments and appliances 5.2.1分析天平Analytical balance 其分度值应为0.1mg或小于0.1mg：毫克组砝码需经校正，并列有校正表备用。 Its value of a scale division should be 0.1 mg or less than 0.1 mg; weights of mg group require correction, and list the correction table for a rainy day.