 |
| Cantidad: | |
|---|---|
DY13516
43229-80-7
C42H52N4O12
Formoterol fumarate
| Index name | Specifications |
| characteristics | A White or almost white or slightly yellow powder |
| Identification | IR Comparison to Formoterol Fumarate Dihydrate CRS |
| PH | NLT5.5 NMT6.5 |
| Optical rotation | -0.10 to +0.10degree |
| Related Substance | |
| Impurity A | Not more than 0.3% |
| Impurity B | Not more than 0.2% |
| Impurity C | Not more than 0.2% |
| Impurity D | Not more than 0.2% |
| Impurity E | Not more than 0.2% |
| Impurity F | Not more than 0.1% |
| Impurity G | Not more than 0.1% |
| Impurity H | Not more than 0.1% |
| Any other unknown impurity | Not more than 0.1% |
| Total impurity | Not more than 0.5% |
| Impurity I | Not more than 0.3% |
| Water | 4.0 to 5.0%.The method of K.F. |
| Assay | 98.5 to 101.5%(anhydrous substance)of C19H24N2O4.1/2C4H4O4 |
| Index name | Specifications |
| characteristics | A White or almost white or slightly yellow powder |
| Identification | IR Comparison to Formoterol Fumarate Dihydrate CRS |
| PH | NLT5.5 NMT6.5 |
| Optical rotation | -0.10 to +0.10degree |
| Related Substance | |
| Impurity A | Not more than 0.3% |
| Impurity B | Not more than 0.2% |
| Impurity C | Not more than 0.2% |
| Impurity D | Not more than 0.2% |
| Impurity E | Not more than 0.2% |
| Impurity F | Not more than 0.1% |
| Impurity G | Not more than 0.1% |
| Impurity H | Not more than 0.1% |
| Any other unknown impurity | Not more than 0.1% |
| Total impurity | Not more than 0.5% |
| Impurity I | Not more than 0.3% |
| Water | 4.0 to 5.0%.The method of K.F. |
| Assay | 98.5 to 101.5%(anhydrous substance)of C19H24N2O4.1/2C4H4O4 |