Aprotinin|Apro-170306-06
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 . Ⅲ (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 | |