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抑肽酶|Apro-170306-06

2017-05-23 16:32:19 万华生化制品 阅读

CERTIFICATE OF ANALYSIS

Product

Aprotinin

Lot No.

Apro-170306-06

Gross Weight

---- g

Mfg date

     2017-03-01

Net Weight

1578.30 g

Exp date

2019-02-28

Total activity

10000 MKIU

Test date

2017-03-28

 

Test Items

Specifications

Results

Appearance

Almost white powder, hygroscopic 

conform

Solubility

Soluble in water and  0.9% NaCl solution practically insoluble in organic solvents (5 mg / ml)

Conform

Clarity of solution

Ref . (15 Ph.Eur.U./ ml)

conform

Absorbance

A 0.80 (absoption-max. : 277nm ± 2nm ; 3.0 Ph.Eur.U. / ml)

0.65

Identification A

Positive

Conform

Identification B

Positive

Conform

Aprotinin oligomers

Max. 1.0%

0.61%

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%

Pyroglutamyl-aprotinin : 0.25%

Any other impurity : 0.35%

Sum of impurity : 0.35%

Loss on drying

≤ 6.0 % (0.100 g , drying in vacuo)

5.0%

Activity

3.0 Ph.Eur.U. /mg

3.52EPU / mg (6336KIU / mg)

PH

5.5-7.0  

6.4

Endotoxin

≤ 0.14 EE / Ph.Eur.U.

Conform

Pyrogens

Absent at 15Ph.Eur.U./ kg / rabbit

Conform

Microbial Limit

TAMC : 102  CFU/g API

TYMC : 102  CFU/g API

Conform

escherobacteriaceae , Pseudomonas aeruginose and Staphylococcus aureus should be absent .

Conform

Abnormal toxicity

Non toxic at 2 Ph.Eur.U. / ml

Conform

Histamine

0.1 μg histamine base / 3 Ph.Eur.U.

Conform

Conclusion

Comply to consult specification

 

Analyst


Checker


Supervisor of QA




标签:   抑肽酶
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