USP标准品的使用和储存

USP标准品的使用和储存

2014-07-08 美药典USP

                               
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To serve its intended purpose, each USP Reference Standard must be properly stored, handled, and used.

    为了实现标准品的使用目的，每个USP标准品必须妥善储存，处理和使用。

1.Suitability for Use (标准品是否适合使用)

Users must ascertain that the Reference Standards they are using are a"Current lot" or a "Previous lot" within the valid use date. Current and previous lot information is available in the Reference Standards listings and catalog.

Users must determine the suitability of Reference Standards for applications and uses not in the USP–NF, Food Chemicals Codex, or Dietary Supplements Compendium. Any other non-specified compendial use is at the User’s sole risk and expense. USP Reference Standards are not intended for use as drugs, dietary supplements, or medical devices.

     用户必须确认正在使用的标准品是“当前批次”还是在有效使用日期之内的“先前批次”。了解批次的相关信息可通过官方网站的“标准品列表和目录”。

     用户必须确认在除《美国药典-国家处方集》，《食品化学法典》或《膳食补充剂法典》之外使用USP标准品的适用性。任何其他非指定药典的使用需由用户承担全部风险和费用。USP标准品不作为药物，膳食补充剂，或医疗设备使用。

2.Directions on the Label of the Reference Standard (标准品标签说明)

Directions for storage and use are on the label of each Reference Standard. These directions are lot-specific and take precedence over any other indications in the corresponding documentary standards. The label includes safety warnings,required information for controlled substances, and calculation values for standards with quantitative applications. For calibrators, acceptance ranges are provided. Where necessary, USP Reference Standards are shipped with additional technical data sheets.

     在每个标准品的标签上均有储存和使用说明。这些说明针对指定批次，优先于在相应的文件标准中的其他说明。标签包括安全警告，受控物质所需信息，应用于定量标准的计算值。对于校正用物质会提供可接受范围。必要时，USP标准品运输时会附加技术数据表。新的标准品标签格式信息已于2014年4月发布，了解详情请微信发送数字1。

3.Directions in USP–NF(USP-NF中的说明)

Refer to the list of revisions, additions, and deletions of individual USP Reference Standards in the official edition of USP–NF. Individual USP or NF monographs specify the USP Reference Standards required for assay and test procedures. The USP–NF General Test Chapter <11> USP Reference Standards provides additional information and instructions for proper use and storage.

    请参考USP-NF生效版本中的USP标准品的修改、添加以及删除列表。单个USP或NF各论中指定含量测定和测试所需的USP标准品。USP-NF通则< 11> USP标准物质提供了更多正确使用和储存标准品的信息和指导。

4.Storage(储存)

Ensure that USP Reference Standards are stored in their original stoppered containers away from heat and humidity and protected from light. Follow any special label directions. (View USP's policy statement on the storage and usage of Reference Standards).

     确保USP标准品储存在原始密封容器中，防止高温高湿且注意避光。遵守产品标签上的指示。(查看USP标准品储存和使用的政策声明)。

5.Weighing(称量)

Ensure that Reference Standard substances are accurately weighed—taking due account of relatively large errors potentially associated with weighing small masses—where it is directed that a standard solution or a standard preparation be prepared for a quantitative determination. See USP–NF General Chapters <41> Weights and Balances and <31> Volumetric Apparatus,and USP–NF General Notices for additional information on the appropriate use of USP Reference Standards.

     确保标准品的准确称定-在定量测试需配制标准溶液等时，应考虑称量值较小时潜在的相对大的偏差。请见USP-NF通则< 41 >称量和天平和< 31 >容量仪器，更多信息，请见USP-NF凡例中有关USP标准品的合理使用部分。

6.Dry(干燥)

• Where a USP Reference Standard is required to be dried before being used, use a clean and dry vessel—and not the original container—as the drying vessel.
        当USP标准品被要求在使用前干燥时，使用洁净和干燥的器皿作为干燥器皿-而不是原始容器。
• Make sure not to dry a specimen repeatedly at temperatures above 25 degrees Celsius.
  确保不在高于25摄氏度以上反复干燥标准品。
• Follow any special drying requirements specified on the Reference Standard label or in specific sections of monographs. (Note that any specific instructions on the label or in the monograph supersede the usual instructions in Procedures under Tests and Assays in USP–NF General Notices).
        遵守标准品标签中或各论某部分明确规定的干燥要求。(注意标签上的 具体说明或在各论中取代USP-NF凡例中测试和测定项下的一般说明)。
• Follow Method I under USP–NF General Chapter <921> Water Determination where the titrimetric determination of water is required at the time a Reference Standard is to be used. Instrumental or microanalytical methods are acceptable for this purpose. When using typical amounts, about 50 mg of the Reference Standard, titrate with a fourfold dilution of the reagent.
        当使用的标准品需做滴定测试时，应遵守USP-NF通则< 921 >水分测定的方法1的规定。仪器或微量分析方法是可以接受的。通常需使用大约50mg的标准品，用稀释4倍的滴定液滴定。
  
  

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