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Hyaluronidase

2019-05-07 03:32:56 Wanhua Biochem Products Read

           

CERTIFICATE OF ANALYSIS

品名Product

玻璃酸酶Hyaluronidase

批号Lot No.

HA-190301

毛重Gross Weight

---- g

生产日期Mfg date

2019-03-08

净重Net Weight

2.5g

有效期Exp date

2021-03-07

总效价Total activity

7.85 MIU

检测日期Test date

2019-03-22

 

项目Test Items

规格Specifications

结果Results

性状

Appearance

白色至微黄色粉末;无臭。

White or yellowish-white , amorphous powder . 

符合规定

Conform

溶解性

Solubility

水中易溶,在乙醇、丙酮或乙醚中不溶

Soluble in water , insoluble in ethanol , acetone or ether .

符合规定

Conform

鉴别1

Identification 1

Positive

符合规定

Conform

鉴别 2

Identification 2

Positive

符合规定

Conform

酸碱度

pH

4.5 ~ 7.5 (3 mg / mL)

6.05

干燥失重

Loss on drying

≤ 5.0 %

3.25%

溶液澄清度与颜色

Appearance of solution

应澄清无色,如显色,应比黄色4号更浅 (0.1g → 10 mL)

Clear and colorless , or yellow Ref . (0.1g → 10 mL)

符合规定

conform

吸光度

Absorbance

280 nm ≤ 0.6 260nm ≤ 0.42

( 300 IU / mL)

280nm : 0.048

260nm : 0.031

酪氨酸

Tyrosine

≤ 0.1 µg / IU (540 nm )

符合规定

Conform

异常毒性

Abnormal toxicity

Non toxic at 10 000 IU / ml

符合规定

Conform

细菌内毒素

Bacterial endotoxins

≤ 0.20 EU / IU

符合规定

Conform

效价

Potency

3000 IU / mg

3140 IU / mg

Conclusion

Comply to CP 2015


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