1 | Description | Colourless crystals. | Colorless crystals or a white, crystalline powder. |
2 | Solubility | Complies | Very soluble in water, soluble in ethanol (96%). |
3 | Identification A (By Chemical test) | Complies | within a few minutes a blue precipitates should be formed or a dark blue should be developed. |
4 | Identification B (By Chemical test) | Complies | A dense white precipitate should be formed. |
5 | Identification C (By Loss on drying) | 39.3% | 39.0% - 40.50% |
6 | Appearance of solution | Complies | Solution A should be clear and colorless. |
7 | pH(5% aq soln) | 8.2 | 7.5-9.0 |
8 | Reducing substances | Complies | The pink color should persist for at least 1 hour. |
9 | Chloride(Cl) | Less than 200ppm | NMT 200ppm. |
10 | Sulphate(SO4) | Less than 200ppm | NMT 200ppm. |
11 | Arsenic(As) | Less than 2ppm | NMT 2ppm. |
12 | Calcium(Ca)&Magnesium(Mg) | 24ppm | NMT 50ppm (NMT 0.65ml of 0.02 M sodium edetate is required) |
13 | Heavy metals | Less than 10ppm | NMT 10ppm |
14 | Iron(Fe) | Less than 10ppm | NMT 10ppm. |
15 | Loss on drying,120°C | 39.32% | 39.00%-40.50% |
16 | Assay (on dried basis) | 100.30% | 99.00% - 101.00% |
17 | Total aerobic microbial count | Less than 100 cfu/gm | NMT 100 cfu/gm |
18 | Total combined yeast and molds count | Less than 10 cfu/gm | NMT 10 cfu/gm |
19 | Escherichia coli | Absent/gm | Should be Absent /gm |
20 | Salmonella | Absent/10gm | Should be Absent /10gm |
21 | Staphylococcus aureus | Absent/gm | Should be Absent /gm |
22 | Pseud. aeruginosa | Absent/gm | Should be Absent /gm |
23 | Bile-tolerant gram negative bacteria | Absent/gm | Should be Absent /gm |
24 | Bacterial endotoxins | Less than 0.5 EU/mg | NMT 0.5 EU/mg |