PARAMETER | U.S.P. | Result |
Appearance | White powder | White powder |
pH | 5.5 -7.0 | 6.4 |
Moisture | 7%max | 6.7% |
Loss on drying | 5%max | 4.1% |
Water Insoluble Substances | 0.25max | 0.18% |
Residue on ignition | 0.5%max | 0.2% |
Heavy metals | 10ppm max | 40ppm |
Arsenic | 2ppm max | 1.6ppm |
Assay | 97%- 102% | 97.5% |
Conductivity | NMT-75 µs/cm | 50µs/cm |
Starch | Negative | Negative |
aerobic bacteria
|
1000CFU/G max | 90CFU/G |
molds and yeast
|
100CFU/G max | 90CFU/G |
Escherichia coli
|
Non detected | Non detected |