1 | Description | Colorless crystalline powder is odorless and is slightly deliquescent. Its solutions are acid to litmus and effervesce with sodium carbonate | Colorless crystals or white, crystalline powder is odorless and is slightly deliquescent. Its solutions are acid to litmus and effervesce with sodium carbonate |
2 | Solubility | Passes | freely soluble in water; practically insoluble in alcohol. |
3 | Assay | 99.5% | 98.0% - 100.5% |
4 | Identification A (By Chemical test) | Complies | Solution should be slightly acid. |
5 | Identification A (Sodium) | Complies | A dense white precipitate should form |
6 | Identification (Phosphate 1) | Complies | A neutral solution should yield yellow precipitate that soluble in 2N nitric acid and in 6N ammonium hydroxide |
7 | Identification (Phosphate 2) | Complies | A yellow precipitate should form of which color does not changes by boiling and which dissolves on addition of ammonia |
8 | Identification (Phosphate 3) | Complies | A yellow colour should develop |
9 | Appearance of solution | Passes | Clear and colorless solution |
10 | Water insoluble matter | 0.03% | NMT 0.15% |
11 | pH(5% aq soln) | 4.34 | 4.1 – 4.7 |
12 | Chloride (Cl) | Less than 0.005% | NMT 0.005% |
13 | Sulfate (SO4) | Less than 0.01% | NMT 0.01% |
14 | Heavy metals (as Pb) | 0.00005% | NMT 0.0005% |
15 | Aluminium, calcium and other elements detectable with ammonia | Passes | The sample solution should not become turbid when rendered slightly alkaline to litmus paper with 6N ammonium hydroxide. |
16 | Arsenic (As) | Less than 0.0001% | NMT 0.0001% |
17 | Iron (Fe) | Not detected | NMT 0.001% |
18 | Substances reducing KMnO4(O) | Passes | The color of the permanganate should not completely discharge |
19 | Loss on drying at 130°C | 22.83% | 22.0% - 24.0% |
20 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
21 | Total Yeast and mold count | Less than 100 CFU/gm | NMT 100 CFU/gm |
22 | Bacterial endotoxins | Less than 2.5IU/gm | NMT 2.5IU/gm |
23 | E.coli | Absent/gm | should be absent /gm |
24 | Pseudomonas aeruginosa | Absent/gm | should be absent /gm |
25 | Staphylococcus aureus | Absent/gm | should be absent /gm |
26 | Salmonella | Absent/10gm | should be absent /10gm |
27 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent /gm |
28 | Candida albicans | Absent/gm | should be absent /gm |