| Appearance |
White hydroscopic, crystalline powder with clear colourless liquid in solution . |
| Assay (on anhydrous basis) |
99.0 - 100.5% |
| Melting point |
148 - 153°C |
| pH |
3.0 - 4.0 |
| Water (H2O) |
Max. 0.5% |
| Residue on ignition |
Max. 0.1% |
| Arsenic (As) |
Max. 0.0002% |
| Lead (Pb) |
Max. 0.00003% |
| Heavy metals (as Pb) |
Max. 0.001% |
| Limits of total amines |
Max. 0.001% |
| Chromatographic purity (by HPLC) |
|
| A) Individual impurity |
Max. 0.3% |
| B) Total impurities |
Max. 2.0% |
| Organic volatile impurities (By GC) |
|
| A) Chloroform |
Max. 600µg/g |
| B) 1,4-Dioxane |
Max. 10µg/g |
| C) Methylene chloride |
Max. 600µg/g |
| D) Trichloroethylene |
Max. 80µg/g |
