1 | Description | White crystalline powder. | White granular crystals or a white, crystalline powder. |
2 | Solubility | Complies | Freely soluble in water, practically insoluble in ethanol (95%) and in ether |
3 | Identification A (By Chemical test) | Complies | Citrate: A dense white precipitate should form. |
4 | Identification B (By Chemical test) | Complies | Sodium: A violate color, white tuns to violet-blue should produce |
5 | Appearance of Solution | Complies | Solution A is clear and colourless. |
6 | Acidity or alkalinity | Complies | Not more than 0.5ml of 0.05M sulphuric acid or 0.1M sodium hydroxide is required. |
7 | Arsenic (As) | Less than 2ppm | NMT 2ppm |
8 | Heavy metals | Less than 10ppm | NMT 10ppm |
9 | Chlorides | Less than 100ppm | NMT 100ppm |
10 | Oxalate | Less than 300ppm | NMT 300ppm (calculated as anhydrous oxalic acid) |
11 | Sulphate (SO4) | Less than 150ppm | NMT 150ppm |
12 | Tartrates | Complies | No crystalline precipitate is formed. |
13 | Readily carbonizable substances | Complies | The solution is not more intensely coloured than reference solution YS2 or GYS2. |
14 | Water | 12.3% | 11.0% - 13.0% |
15 | Assay (Anhydrous basis) | 99.7% | 99.0% - 101.0% |
16 | pH (5% aq soln) | 7.7 | 7.5-8.5 |
17 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm |
18 | Particle size | 100% passes through 40 mesh. | 100% should pass through 40 mesh. |