| I tems | S tandards | R esults |
| C haracteristics | White to o ff- w hite crystalline powder | White crystalline powder |
| I dentification | By IR | Complies |
| By HPLC | Complies | |
| Melting Point | 166 .0 ºC~169 .0 ºC | 16 7.0 ºC~16 8.0 ºC |
| Loss on Drying | ≤ 0.50 % | 0.12% |
| H eavy M etal | ≤ 2 0ppm | Complies |
| Residue on Ignition | ≤ 0. 10 % | 0.03% |
| Chloride | ≤ 0. 014 % | Complies |
| Related Substances | Any single impurity : ≤ 0.10% | 0.04% |
| Total i mpurities : ≤ 0.50% | 0.08% | |
|
A
ssay
(HPLC basis on drying) |
≥ 99.0% | 99.60 % |
| Reference Standard | In-house Standard | |
| Conclusion | The product complie d to In-house standard . | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |