| Sl. No. |
Test Parameter |
Specification |
| 1 |
Description |
White or almost white powder |
| 2 |
Solubility |
Water : Practically insoluble
MDC : Freely soluble
Acetone : Sparingly soluble
Alcohol : Slightly soluble
|
| 3 |
Identification
IR Absorption
Spectrum
|
IR absorption Spectrum matches the Standard Spectrum.
UV absorption Spectrum matches the Standard Spectrum.
The RT of main peak in sample preparation matches with that of working standard. |
| 4 |
Loss on drying |
144OC-150OC |
| 5 |
Heavy metals |
NMT 0.5% |
| 6 |
Sulphated ash |
NMT 0.1% |
| 7 |
Assay (on dry basis) |
NMT 300 ppm |
| 8 |
Related Substances
By HPLC
|
Impurity F NMT 0.1%
Unspecified Impurity NMT 0.10%
Sum of impurities other than F NMT 0.2%
Impurity B NMT 2ppm
|
