供应WHO11/184可溯源高分子量尿激酶国际标准物质

供应WHO11/184可溯源高分子量尿激酶国际标准物质

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The potency of the Standard was determined by International Collaborative Study and found to be 3200 IU per ampoule in comparison with the 1st International Standard for High Molecular Weight Urokinase (87/594) (1). The Standard was established by the Expert Committee on Biological Standardisation of the World Health Organisation (WHO) in October 2012 and full details of the calibration study can be found in document WHO/BS/2012.2205. The potency of 3200 IU per ampoule was assigned using fibrin-based clot lysis assay methods. Caution is advised when interpreting results using alternative assay methods. This Standard is intended for use as an activity standard in enzymatic assays.Active site titration of the bulk material provided an estimate for active enzyme in the ampoule, after reconstitution with 1 ml water, of 380 nM,equivalent to approximately 21 µg urokinase per ampoule. However this value is only an estimate from one laboratory and should be treated as a guide only. The Standard has not been assigned a value for antigen.

This preparation is not for administration to humans or animals in the human food chain. WHO11/184

The preparation contains material of human origin, and either the final product or the source materials, from which it is derived, have been tested and found negative for HBsAg, anti-HIV and HCV RNA. As with all materials of biological origin, this preparation should be regarded as potentially hazardous to health. It should be used and discarded according to your own laboratory’s safety procedures. Such safety procedures should include the wearing of protective gloves and avoiding the generation of aerosols. Care should be exercised in opening ampoules or vials, to avoid cuts. 可溯源高分子量尿激酶国际标准物质

该标准品的效力通过国际合作研究确定,与第一个高分子量尿激酶国际标准品(87/594)(1)相比,每安瓿为3200 IU。该标准由世界卫生组织(WHO)生物标准化专家委员会于2012年10月制定,校准研究的详细信息见文件世界卫生组织/BS/2012.2205。使用基于纤维蛋白的凝块溶解测定方法分配每安瓿3200IU的效力。当使用替代分析方法解释结果时,建议谨慎。本标准旨在用作酶测定中的活性标准。散装材料的活性位点滴定提供了用1毫升水重构后安瓿中活性酶的估计值380 nM,相当于每安瓿约21µg尿激酶。然而,该值仅为一个实验室的估计值,应仅作为指南。本标准未指定抗原值。

该制剂不适用于人类或人类食物链中的动物。

该制剂含有人类来源的材料,其最终产物或来源材料经过测试,发现HBsAg、抗HIV和HCV RNA呈阴性。与所有生物来源的材料一样,这种制剂应被视为对健康有潜在危害。应根据您自己实验室的安全程序使用和丢弃它。此类安全程序应包括佩戴防护手套和避免产生气溶胶。打开安瓿或小瓶时应小心,以避免割伤。