| Appearance |
White hydroscopic, crystalline powder with clear colourless Liquid in solution,melt between 148°C & 153°C is odorless, or may have faint trimethylamine odor |
| Assay (on anhydrous basis) |
99.0 to 100.5% |
| Solubility |
To comply |
| Identification 'A' ( by IR) |
To comply |
| Identification 'B' |
To comply |
| Specific optical rotation ([α]20/D) |
Between + 17.5° and + 18.5° |
| pH |
3.0 to 4.0 |
| Water (H2O) |
Max 0.5% |
| Residue on ignition |
Max 0.1% |
| Arsenic (As) |
Max 0.0002% |
| Lead (Pb) |
Max 0.00003% |
| Heavy metal |
Max 0.001% |
| Limit 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 |
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