 |
| Cantidad: | |
|---|---|
DY2604
2392-39-4
219-243-0
C22H30FO8P.2Na
Dexamethasone sodium phosphate
| Index Name | Specifications |
| Appearance | White to off-white hygroscopic powder |
| Identification | 1) Complies by IR 2) Complies by TLC |
| Appearance of solution | Clear and not more intensely colured than reference soution B7 |
| PH | 7.5 to 9.5 |
| Specific optical rotation | +75 to +83 degree |
| Related substances | Principal impurity not more than 0.5% Total impurities not more than 1.0% |
| Inorganic phosphates | 1.0%Max |
| Ethanol | 5000 ppm Max |
| Ethanol and water | 13.0%Max |
| Total aerobic microbial count | 900 cfu/g Max |
| Total combined molds and yeasts count | 90 cfu/gMax |
| Assay | 97.0 to 103.0% on dried basis |
| Index Name | Specifications |
| Appearance | White to off-white hygroscopic powder |
| Identification | 1) Complies by IR 2) Complies by TLC |
| Appearance of solution | Clear and not more intensely colured than reference soution B7 |
| PH | 7.5 to 9.5 |
| Specific optical rotation | +75 to +83 degree |
| Related substances | Principal impurity not more than 0.5% Total impurities not more than 1.0% |
| Inorganic phosphates | 1.0%Max |
| Ethanol | 5000 ppm Max |
| Ethanol and water | 13.0%Max |
| Total aerobic microbial count | 900 cfu/g Max |
| Total combined molds and yeasts count | 90 cfu/gMax |
| Assay | 97.0 to 103.0% on dried basis |