|
Item |
Standard |
Results |
|
Appearance |
A white or almost white crystalline powder or colorless crystals |
Conforms |
|
Solubility |
Freely soluble in water and in anhydrous ethanol, slightly soluble in methylene chloride |
Conforms |
|
Identification |
IR TEST: Their absorption spectrum is concordant with the spectrum obtained with Nicotinamide CRS |
Conforms |
|
TLC: The main spot in the chromatogram are similar in position and size to those in chromatograms obtained with reference solution |
Conforms |
|
|
Appearance of 5% w/v solution: Not more intensely colored than reference solution |
Conforms |
|
|
Assay |
99.0~101.0% |
99.6% |
|
Melting Point |
128℃-131℃ |
129.8-129.9℃ |
|
pH(in 5% w/v solution) |
6.0-7.5 |
7.4 |
|
Loss on drying |
≤0.5% |
0.12% |
|
Sulphated ash |
≤0.1% |
0.06% |
|
Heavy Metal |
≤20 ppm |
Conforms |
