| Item |
Requirement |
Result |
| Description |
White to yellowish-white powder, slightly hygroscopic |
Yellowish-white powder, slightly hygroscopic |
Identification
(IR, UV, HPLC)
|
Conform to the structure |
Comply |
| Solubility |
Soluble in water, very soluble in acetonitrile, in ethanol(96%) and in methylene chloride |
Comply |
| Appearance of Solution |
Clear and not more intensely colured than reference solution Y7 |
Comply |
| Methyl benzenesulphonate |
Not more than 10ppm |
6ppm |
| Water |
Not more than 5.0% |
1.47% |
| Heavy Metals |
Less than 20ppm |
Comply |
| Sulphated ash |
Not more than 0.2% |
0.13% |
Isomer ratio
trans-trans
cis-trans
cis-cis |
5.0%~6.5%
34.5%~38.5%
55.0%~60.0%
|
5.88%
35.54%
55.38% |
| Related Substances (HPLC, Area %) |
Individual: Not more than 1.0%
Total: Not more than 3.5%
|
Comply
3.2% |
| Assay
(anhydrous substance)
|
96.0%~102.0% |
96.7% |
| Conclusion: |
Complies with requirements of BP 2005 |
