1 | Appearance | Colorless crystals | Colorless crystals. |
2 | Solubility | Passes. | Very soluble in water, soluble in ethanol (96%) |
3 | Identification A (By Chemical test) | Complies | It should comply with the test for sodium (USP) |
4 | Identification B (By Chemical test) | Complies | It should comply with the test for acetate (USP) |
5 | Identification C (By Loss on drying) | 39.22% | 39.0% - 40.50% |
6 | Appearance of solution | Passes | Solution S should be clear and colorless. |
7 | pH(5% aq soln) | 8.53 | 7.5-9.0 |
8 | Insoluble matter | 0.007% | 0.05% max |
9 | Reducing substances | Passes | The pink color should persist for at least 1 hour. |
10 | Chloride(Cl) | NMT 200ppm | Not more than 200ppm (Ph.Eur) |
11 | Sulphate(SO4) | NMT 50ppm | Not more than 50ppm (USP) |
12 | Arsenic(As) | NMT 2ppm | Not more than 2ppm |
13 | Calcium(Ca)&Magnesium(Mg) | Passes | No turbidity should be produced within 5 minutes. (USP) |
14 | Potassium(K) | Passes | No precipitate should be formed. |
15 | Heavy metals | NMT 10ppm | Not more than 10ppm |
16 | Iron(Fe) | NMT 10ppm | Not more than 10ppm |
17 | Loss on drying,120°C | 39.22% | 39.00%-40.50% |
18 | Assay (on dried basis) | 99.50% | 99.00% - 101.00% |
19 | Acetic acid as residual solvent | Not detected | Not more than 0.5% |