Appearance |
A white or greyish-white, crystalline powder; odourless. It darkens on exposure to air and light, decomposition being faster in the presence of moisture and athigher temperatures. |
Assay (on anhydrous basis) |
98.0-101.0% |
Solubility |
Freely soluble in water, slightly soluble in ethanol(95%), practically insoluble in chloroform and in |
Appearance of solution |
To comply IP test |
Identification A (IR spectrum) |
To confirm the structure |
Identification ‘B’ |
Absorption maxima at 279 nm, about 0.4 absorbance |
Identification 'C' |
It gives reaction of tartrate |
Related substance (by HPLC) |
|
Impurity A |
Max 0.3% |
Impurity B, C |
Max 0.2% each |
Total unspecified impurities |
Max 0.1% each |
Total impurities |
Max 0.6% |
Phenones (by UV) |
Max 0.1 absorbance at 310 nm |
Loss on drying |
Max 0.5% |
Sulphated ash |
Max 0.1% |
pH (1% w/v solution) |
2.8 - 4.0 |
Specific optical rotation ([α]20/D) |
-50.0° to -54.0° |