| 01. |
Description |
A White or almost white Powder |
| 02. |
Identification |
| A) By Infra-red spectrophotometer |
The Infra-red absorption spectrum of the sample should exhibit maxima only at the same wavelengths as that of a similar preparation of standard. |
| B) By TLC |
The principal spot in the chromatogram obtained with test solution (b) is similar in position, color and size to principal spot in chromatogram obtained with reference solution (a). |
| C) By Chemical |
The suspension obtained is greenish blue. |
| 03. |
Melting Point |
Melts at about 202ºC |
| 04. |
Solubility |
Practically insoluble in water, freely soluble in ethanol (96%), slightly soluble in acetone, practically insoluble in methylene chloride. |
| 05. |
Specific Optical Rotation (On dried basis) |
Between +58.0º and +62.0º (On dried basis) |
| 06. |
Impurity C by TLC |
Not more than 0.1% |
| 07. |
Related substances by HPLC |
1) Impurity A |
Not more than 1.0% |
| 2) Unspecified single impurity |
Not more than 0.1% |
| 3) Total impurity |
Not more than 1.5% |
| 08. |
Heavy Metals |
Not more than 20 ppm |
| 09. |
Sulphated Ash |
Not more than 0.1% w/w |
| 10. |
Loss on Drying |
Not more than 1.0% w/w |
| 11. |
Assay (By Titration) |
Between 99.0% and 101.0% w/w (On Dried basis) |