| 1. |
Description |
A White or yellowish-white crystalline powder,
Slightly hygroscopic.
|
| 2. |
Identification |
A. Determine by IR |
| B. Determine by HPLC |
| 3. |
Appearance of solution |
Sample solution is clear and not more intensely colored than
reference solution BYS7.
|
| 4. |
Specific optical rotation |
Between -20° to -17° |
| 5. |
Related substances |
Individual impurities: NMT 2.5 % |
| other impurities: NMT 1.0 % |
| Total Impurities: NMT 5.0 % |
| 6. |
Water |
NMT 1.0 % |
| 7. |
Assay |
H2B1a + H2B1b : 95.0 % to 102.0 %
H2B1a / (H2B1a + H2B1b) : NLT 90 %
|
| 8. |
Sulphated Ash |
NMT 0.1 % |
| 9. |
Ethanol and Formamide by gas chromatography
|
| Ethanol |
NMT 5.0 % |
| Formamide |
NMT 3.0 % |
| 10. |
Heavy metals |
NMT 20 ppm |
