Gross Weight

---- g

Mfg date

     2017-03-07

Net Weight

120 g

Exp date

2019-03-06

Total activity

672 M KIU

Test date

2017-03-24

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 . Ⅲ (15 Ph.Eur.U./ ml)

conform

Absorbance

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

0.61

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 : 0.38%

Any other impurity : 0.41%

Sum of impurity : 0.41%

Loss on drying

≤ 6.0 % (0.100 g , drying in vacuo)

5.1%

Activity

≥3.0 Ph.Eur.U. /mg

3.11EPU / mg (5600KIU / mg)

PH

5.5-7.0  

6.2

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 EP 8