 |
| Cantidad: | |
|---|---|
74103-07-4
C19H24N2O6
Toradol
| Index Name | Specifications |
| Appearance | White to almost white crystalline powder |
| Identification | UV: Maximum absorption: respectively at 243nm, 318nm Minimum absorption: at 268nm |
| IR :Concordant with the spectrum obtained with Ketrolac tormethamine CRS | |
| TLC :Color and position of principal spot obtained with test solution consistent with that of the reference solution | |
| PH | 5.7 to 6.7 |
| Melting point | 165 to 170 Deg C with decomposition |
| Clarity and color | The solution should be clear and colorless, if not, not more intensely turbid than No. 1 reference solution and not more intensely colored than reference solution of yellow-1 |
| Related substances | 1-ketone-ketorolac acid: 0.1% max |
| 1-hydroxyl-ketorolac acid: 0.1% max | |
| Other single impurity: 0.5% max | |
| Total impurities: 1.0% max | |
| Loss on drying | 0.5% max |
| Residue on ignition | 0.1% max |
| Heavy metals | 0.002% max |
| Microorganism limits | Bacteria amount: 1000cfu/g max |
| Mould and yeast amount: 100cfu/g | |
| Escheriohia coil: undetectable | |
| Aassay(on dried basis) | 98.5% to 101.5% |
| Index Name | Specifications |
| Appearance | White to almost white crystalline powder |
| Identification | UV: Maximum absorption: respectively at 243nm, 318nm Minimum absorption: at 268nm |
| IR :Concordant with the spectrum obtained with Ketrolac tormethamine CRS | |
| TLC :Color and position of principal spot obtained with test solution consistent with that of the reference solution | |
| PH | 5.7 to 6.7 |
| Melting point | 165 to 170 Deg C with decomposition |
| Clarity and color | The solution should be clear and colorless, if not, not more intensely turbid than No. 1 reference solution and not more intensely colored than reference solution of yellow-1 |
| Related substances | 1-ketone-ketorolac acid: 0.1% max |
| 1-hydroxyl-ketorolac acid: 0.1% max | |
| Other single impurity: 0.5% max | |
| Total impurities: 1.0% max | |
| Loss on drying | 0.5% max |
| Residue on ignition | 0.1% max |
| Heavy metals | 0.002% max |
| Microorganism limits | Bacteria amount: 1000cfu/g max |
| Mould and yeast amount: 100cfu/g | |
| Escheriohia coil: undetectable | |
| Aassay(on dried basis) | 98.5% to 101.5% |