1 | Appearance | White crystalline powder. | White crystalline powder. |
2 | Solubility | Complies | 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 1) | Complies | No yellow precipitate should form. |
5 | Identification B (By Chemical test 2) | Complies | No precipitate should form. |
6 | Identification B (By Chemical test 3) | Complies | The red color should discharge, leaving a yellowish solution. |
7 | Identification C (By Chemical test) | Complies | No precipitate should form. |
8 | Identification(Sodium) | Complies | A dense white precipitate should form. |
9 | Appearance of Solution | Complies | Solution should be clear and colorless. |
10 | pH | 4.4 | 4.0-5.5 |
11 | Impurity A (Nitrilotriacetic acid) | 0.02% | NMT 0.1% |
12 | Calcium (Ca) | Complies | No precipitate should form. |
13 | Iron (Fe) | Less than 80ppm | NMT 80ppm |
14 | Assay (on dried basis) | 99.8% | 99.0% - 101.0% |
15 | Loss on drying at 150° for 6 Hr | 9.8% | 8.7%-11.4% |