Organoleptic characteristics
|
| Appearance |
Fine, hygroscopic powder |
| Colour |
White |
|
Identifications
|
| Sodium |
Positive |
| Electrophoresis |
Same mobility as the standard |
| Specific Rotation |
≥ +35º |
|
Assay |
≥ 150 UI/mg |
Physical-chemical parameters
|
| Appearance in solution |
≤ 2.5 NTU |
| Colour in solution (5000 UI/ml) |
J5, B5, JB5 |
| pH (1% H2O) |
5.5-8.0 |
| Proteic impurities (260 nm) |
≤ 0.15 |
| Nucleotidic impurities (280 nm) |
≤ 0.10 |
| Nitrogen |
≤ 2.5% |
| Loss on drying (60ºC, 3h, 5 Torr) |
≤ 3.5% ≤ 8.0% (calcium) |
| Heavy metals |
≤ 20 ppm |
| Sulphated ash |
30-41% |
|
Microbiological Data
|
| Total aerobic count |
≤ 50 cfu/g |
| Pathogens |
Absence/g |
| Bacterial endotoxins |
0.01 EU/IU |
|
Specifications according to Ph. Eur. Monograph. |
