| ITEM | STANDARD | RESULTS |
| Appearance | White or Yellowish-white crystalline powder | Qualified |
| Solubility | Practically insoluble in water, freely soluble in methylene chloride, soluble in alcohol | Qualified |
| Identification | IR:Corresponds with that of CRS Standard HPLC:The retention time for H2BIa and H2BIb corresponds with that of Standard preparation |
Qualified Qualified |
| Appearance of Solution | Clear and not more intensely colored than BY7 | Qualified |
| Specific Optical Rotation ( anhydrous and ethanol-free substance ) |
-17~-20 | -18.1 |
| Specific Optical Rotation | Individual Impurities ( RRT 1.3-1.5 )≤ 2.5 | 1-1<0.05 K:2.2 |
| Any other individual impurities≤ 1 | C:0.1 A:0.3 J:0.2 H:0.3 D:0.1 F:0.2 E:0.6 1-2:0.2 |
|
| Total≤5 | 4.2 | |
| Disregard limit≤0.05 | 0.05 | |
| Ethanol and Formamide ( % ) | Ethanol≤5.0 Formamide≤3.0 |
3.82 2.81 |
| Heavy Metal ( % ) | ≤ 0.002 | <0.002 |
| Water ( % ) | ≤ 1.0 | 0.21 |
| Sulphated ash ( % ) | ≤ 0.1 | 0.07 |
| Residue of solvent ( toluene ) | ≤ 890ppm | <890ppm |
| Assay ( % ) ( HPLC, Basis on drying ) |
H2BIa/( H2BIa+H2BIb )≥90.0 95.0≤ H2BIa+H2BIb≤102.0 |
97.6 95.8 |
| Conclusion | Complies with the requirements of EP7 | |
