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Urokinase|UK-141118-18

2017-05-23 15:54:36 Wanhua Biochem Products Read

Certificate of Analysis

 

Product:  Urokinase                           产品名称:  尿激酶

Batch NO.: UK-141118-18                      批号:UK-141118-18

Net weight: 18.7 克                           净重量:18.7

Batch qty.: 2000 MIU                          批数量:2000 百万单位

Manufacture Date: 2014-11-02                   生产日期:2014-11-02

Expiry Date: 2016-11-01                                             有效期:2016-11-01

Date of Analysis2014-11-15                                                                                 检验日期:2014-11-15

Date of Report: 2015-02-27                     报告日期:2015-02-27

 

 

TEST

检验项目

SPECIFICATIONS

规格

FOUND

结果

Description

性状

A white or almost white, amorphous powder.

应为白色或类白色粉末

almost white, amorphous powder.

为类白色粉末

Indentification

鉴别

Positive

应为阳性

Conforms

阳性

Color and clarity of solution

溶液澄清度与颜色

Colorless and clear

应澄清无色

Colorless and clear

澄清无色

HBs-Ag(ELISA)

乙肝表面抗原

Negative

应为阴性

Negative

阴性

Abnormal toxicity

异常毒性

The mouse should not have dyspoea and convulsion in 30mins after the administration

30分钟内小鼠无呼吸困难和抽搐

Conforms

合格

Thromboplastic contaminants

凝血样活性物质

NLT150 IU / ml

不小于150 IU / ml

Conforms

合格

Bacterial endotoxins

细菌内毒素

N.M.T 0.002 EU / IU

IU尿激酶的内毒素不超过0.002EU

Conforms

合格

HMW UK

高分子尿激酶

N.L.T 90%(HPLC)

不小于90%(液相色谱)

92%

Potency

效价

N.L.T 70000 IU / mg

不小于70000 IU / mg

106681.2 IU/mg

106681.2 单位/毫克

Protein

蛋白质

Valu on determination

测得值

0.65 mg.pr/mg

0.65毫克蛋白/毫克

Specific activity

比活

N.L.T 100,000 IU/mg.protein

不少于100000单位/毫克蛋白

164124.9IU/mg.pr

164124.9单位/毫克蛋白

 

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