| I tems | S tandards | R esults |
| Appearance | Orange- r ed c rystalline p owder, h ygroscopic, n o v isible e vidence o f c ontamination b y f oreign m aterial | Complies |
| I dentification | B y IR | Complies |
| By HPLC | Complies | |
| Solubility | Soluble in w ater; s lightly soluble in m ethanol;Practically insoluble in c hloroform and d iethyl e ther | Complies |
| pH | 4.0~5.5 | 5. 15 |
| Water Content | ≤ 4.00 % | 1. 35 % |
| H eavy M etals | ≤20ppm | Complies |
| Residual Solvents | Acetone: ≤ 5000ppm | 8 00ppm |
| Acetone & alcohol: ≤ 25000ppm | 4 2 00ppm | |
| R elated S ubstances | Any single unknown impurity : ≤ 1.00% | Complies |
| Total impurities : ≤ 2.00% | 0. 38 % | |
|
A
ssay
(HPLC basis on drying) |
98.0% ~102.0% | 99. 72 % |
| Reference Standard | USP Standard | |
| Conclusion | The product complie d to USP standard . | |
| Storage |
Preserve in tight,light-resistant containers in a cool place
under 2 ºC to 8 ºC temperature. |
|