产品名称

Products

来源

Origin

规格

Specifications

标准

Standard basis

抑肽酶粗品

Crude 

Aprotinin

牛肺

Bovine lungs

效价（Potency)：≥60 KIU/mg      

抑肽酶半成品Semipurified Aprotinin

牛肺

Bovine lungs

效价（Potency）：3.0 ≥ EPU/mg 

高分子蛋白质 Aprotinin oligomers：≤1.0%         

细菌内毒素（Bacterial endotoxins）：conform

抑肽酶成品

Purified Aprotinin

牛肺

Bovine lungs

效价potency：3.0 ≥ EPU/mg                   

高分子蛋白质Aprotinin oligomers：≤1.0%

N-抑肽酶和有关物（Impurity C）：≤1.0%；

单个杂质峰（Any other impurity）：≤0.5%;

杂质峰和（sum）：≤1.0%                        

细菌内毒素（Bacterial endotoxins）：conform

CP2020

EP11.0

尿激酶粗品

Crude Urokinase

男性尿

Human male urine

效价（Potency）:≥30 IU/mg

比活（Specific activity）:≥ 300 IU/mg.p

尿激酶成品Purified Urokinase

男性尿

Human male urine

Specific activity: ≥ 80 000 IU/mg.p

HMW: ≥85%

EP11.0

尿激酶成品Purified Urokinase

男性尿

Human male urine

比活（Specific activity）:≥ 120 000 IU/mg.p

大分子含量（HMW）: ≥90%

CP2020

EP11.0

尿激酶成品Purified Urokinase

男性尿

Human male urine

比活（Specific activity）:≥ 120 000 IU/mg.p

大分子含量（HMW）: ≥95%

CP2020

EP11.0

玻璃酸酶粗品

crude Hyaluronidase

羊/牛睾丸

Sheep/Bovine Testes

 效价（Potency）：≥300 IU/mg,

玻璃酸酶成品

Purified Hyaluronidase

羊/牛睾丸

Sheep/Bovine Testes

 效价（Potency）：≥300 IU/mg

CP2020

EP11.0

玻璃酸酶成品

Purified Hyaluronidase

羊/牛睾丸

Sheep/Bovine Testes

 效价（Potency）：≥1000 IU/mg

CP2020

EP11.0

玻璃酸酶成品

Purified Hyaluronidase

羊/牛睾丸

Sheep/Bovine Testes

 效价（Potency）：≥3000IU/mg

CP2020

EP11.0

Test Items

Specifications

Appearance

Deep yellow to yellow wet paste

Identification

Positive

Activity

≥60 KIU /mg

Test Items

Specifications

Appearance

Almost white hygroscopic powder 

Solubility

Soluble in water and isotonic solution , practically insoluble in organic solvents .

Identification

Positive

Appearance of solution

Solution is clear (15 Ph.Eur.U./ ml)

Absorbance

A ≤ 0.80 ( 277nm ± 2nm ; 3.0 Ph.Eur.U. / ml)

Aprotinin oligomers

Max. 1.0%

Pyroglutamyl-aprotinin and related compounds

Pyroglutamyl-aprotinin max. 1.0%

Any other impurity max. 0.5%

Sum of impurity other than pyroglutamyl-aprotinin max. 1%

Loss on drying

≤ 6.0 % (0.100 g , drying in vacuo)

Bacterial endotoxins

≤ 0.14 EE / Ph.Eur.U.

Activity

≥3.0 Ph.Eur.U. /mg

Microbial Limit

TAMC : ≤ 10²  CFU/g API

TYMC : ≤ 10²  CFU/g API

escherobacteriaceae , Pseudomonas aeruginose and Staphylococcus aureus should be absent .

Histamine

0.2 μg histamine / 3 Ph.Eur.U.

Standard basis

CP2020   EP11.0

Item

Specification

Appearance

Slight yellow to yellow wet paste

Identification

Positive

Potency

>20 IU/mg

 HBs Ag

Negative

 Anti-HCV

Negative

 Anti-HIV 1/2

Negative

Test Items

Specifications

Appearance  

White or almost white, amorphous powder

Solubility

Soluble in water

Identification

Positive

Appearance of solution

Clear and colourless (10 mg/10ml)

Thromboplastic contaminants

≤ 150 IU / ml

Specific activity

≥  80,000 IU/mg. Protein

Molecular fraction

HMW UK > 85%

Bacterial endotoxin

< 2EU/20,000 IU

HBs-Ag  

Negative(50,000 IU/ml)

Anti-HIV 1/2

Negative(50,000 IU/ml)

Anti-HCV

Negative (50,000 IU/ml)

Standard basis

CP2020   EP11.0

Test Items

Specifications

Appearance  

White or almost white, amorphous powder

Solubility

Soluble in water

Identification

Positive

Appearance of solution

Clear and colourless (10 mg/10ml)

Thromboplastic contaminants

≤ 150 IU / ml

Specific activity

≥  100,000 IU/mg. Protein

Molecular fraction

HMW UK > 90%

Bacterial endotoxin

< 2EU/20,000 IU

HBs-Ag  

Negative(50,000 IU/ml)

Anti-HIV 1/2

Negative(50,000 IU/ml)

Anti-HCV

Negative (50,000 IU/ml)

Standard basis

CP2020   EP11.0

Test Items

Specifications

Appearance

White or almost white, amorphous powder

Solubility

Soluble in water

Identification

Positive

Appearance of solution

Clear and colourless (10 mg/10ml)

Thromboplastic contaminants

≤ 150 IU / ml

Specific activity

≥  100,000 IU/mg. Protein

Molecular fraction

HMW UK >95%

Bacterial endotoxin

< 2EU/20,000 IU

HBs-Ag  

Negative(50,000 IU/ml)

Anti-HIV 1/2

Negative(50,000 IU/ml)

Anti-HCV

Negative (50,000 IU/ml)

Standard basis  

CP2020   EP11.0

Item

Specification

Appearance

Slight yellow to yellow solid powder

Identification

Positive

pH

4.5 ~ 7.5

Bacterial endotoxin

≤ 0.2EU/IU

Potency

≥ 200 IU/mg

Test Items

Specifications

Apprearance

White or yellowish-white , amorphous powder .

Solubility

Soluble in water , practically insoluble in acetone and anhydrous ethanol

Identification

Positive

Appearance of solution

Clear (0.1 g/10ml)

pH

4.5 to 7.5

Loss on drying

≤ 5.0 % (60℃ , ≤ 670 Pa for 2 h)

Bacterial endotoxin

< 0.2EU/ IU

Potency

≥ 300 IU / mg

Standard basis  

CP2020   EP11.0

Test Items

Specifications

Apprearance

White or yellowish-white , amorphous powder .

Solubility

Soluble in water , practically insoluble in acetone and anhydrous ethanol

Identification

Positive

Appearance of solution

Clear (0.1 g/10ml)

pH

4.5 to 7.5

Loss on drying

≤ 5.0 % (60℃ , ≤ 670 Pa for 2 h)

Bacterial endotoxin

< 0.2EU/ IU

Potency

≥ 1000 IU / mg

Standard basis  

CP2020   EP11.0

Test Items

Specifications

Apprearance

White or yellowish-white , amorphous powder .

Solubility

Soluble in water , practically insoluble in acetone and anhydrous ethanol

Identification

Positive

Appearance of solution

Clear (0.1 g/10ml)

pH

4.5 to 7.5

Loss on drying

≤ 5.0 % (60℃ , ≤ 670 Pa for 2 h)

Bacterial endotoxin

< 0.2EU/ IU

Potency

≥ 3000 IU / mg

Standard basis  

CP2020   EP11.0