TESTS | SPECIFICATION |
Description | A white to almost white powder |
Solubility | Practically insoluble in water, freely soluble in methylene chloride, soluble in methanol, sparingly soluble in Ethanol (96%). |
Melting point | Between 1480C to 1520C. |
Infrared absorption | Infrared absorption spectrum of sample should be concordant with that of working standard spectrum. |
Specific Rotation | Between -1.00 and +1.00 (T= 200C) |
Heavy Metals | NMT 0.002% |
Loss on drying | NMT 0.5%w/w |
Residue on ignition | NMT 0.1%w/w |
Related substances by TLC | The principal spot obtained from the test solution has about the same size and Rf value as that obtained from the standard solution and the sum of the intensities of any secondary spots obtained from the test solution does not exceed the intensity of the principal spot obtained from the diluted standard solution. (NMT: 0.5%) |
Assay by titrimetry (on dried basis) | NLT 98.0% w/w & NMT 102.0%w/w |
Residual Solvents Methanol Acetone Ethyl Acetate | NMT 3000 ppm MNT 5000 ppm NMT 5000 ppm |
Bulk Density | |
Untapped Density | For your information |
Tapped Density | For your information |