1 | Appearance | White crystalline powder | White or almost white, crystalline powder. |
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 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 (By Chemical test) | Complies | A dense white precipitate should form . |
7 | Appearance of Solution | Passes | Solution should be clear and colorless. |
8 | pH | 4.55 | 4.0-5.5 |
9 | Impurity A (Nitrilotriacetic acid) | Less than 0.1% | 0.1% max |
10 | Iron (Fe) | Less than 80ppm | 80ppm max |
11 | Assay | 98.83% | 98.5%- 101.0% |