1 | Description | A white, crystalline powder; odourless. | A white, crystalline powder; odourless. |
2 | Solubility | Passes | Soluble in water, practically insoluble in ethanol (96%) |
3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard |
4 | Identification B (By Chemical test) | Complies | No precipitate should produce. |
5 | Identification C (By Chemical test) | Complies | No precipitate should produce. |
6 | Identification D (Sodium 1) | Complies | A dense white precipitate should form. |
7 | Identification D (Sodium 2) | Complies | No precipitate should form. |
8 | Appearance of Solution | Passes | A 5% w/v solution in carbon dioxide-free water should be clear and colourless |
9 | pH of 5%w/v solution | 4.37 | 4.0-5.5 |
10 | Impurity A (Nitrilotriacetic acid) | Not detected | 0.1% max |
11 | Heavy metals | Less than 20ppm | 20ppm max |
12 | Iron (Fe) | Less than 80ppm | 80ppm max |
13 | Assay | 99.52% | 98.5%- 101.0% |