| I tems | S tandards | R esults |
| Appearance | Off-white to white solid powder | Complies |
| I dentification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Soluble in DMSO, slightly soluble in water | Complies |
| Loss on Drying | ≤ 1.00 % | 0. 55 % |
| H eavy M etal s | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 0. 10 % | 0.0 5 % |
| Residual Solvent | Dichloromethane: ≤ 600 ppm | ND |
| Methanol: ≤ 3000 ppm | ND | |
| Ethyl Acetate: ≤ 5000 ppm | ND | |
| Toluene: ≤ 890 ppm | ND | |
| Acetone: ≤ 5000 ppm | ND | |
| Related Substances | Any single impurity : ≤ 0. 2 0% | Complies |
| Total Impurities : ≤ 1.00% | 0. 25 % | |
|
A
ssay
(HPLC basis on drying) |
98.0% ~ 102.0% | 99. 80 % |
| Particle Size | D90: ≤ 150 μ m | Complies |
| 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 | |