1 | Appearance/Description | Colorless crystalline powder, slightly deliquescent in moist air. | Colorless crystals or white, crystalline powder/ granular crystals, slightly deliquescent in moist air. |
2 | Solubility | Complies | Freely soluble in water & very soluble in boiling water. Insoluble in alcohol & Practically insoluble in ethanol (96%) |
3 | Identification (Citrate) | Complies | Solution should produce violet colour turning to violet blue |
4 | Identification (Citrate ) | Complies | A light red color should produce |
5 | Identification(Sodium) | Complies | A dense white precipitate should form. |
6 | Identification (reaction upon ignition) | Complies | Upon ignition, it should yield an alkaline residue that effervesces when treated with 3N hydrochloric acid |
7 | Appearance of Solution | Complies | Clear and colourless solution |
8 | Acidity or alkalinity | Complies | Not more than 0.2 mL of 0.1M hydrochloric acid or 0.1 M sodium hydroxide is required to change the color of the indicator |
9 | Alkalinity | Complies | No pink colour is produced by 1 drop of phenolphthalein. |
10 | Readily carbonizable substances | Complies | The solution is not more intensely coloured than reference solution Y2 or GY2. |
11 | Chlorides | Less than 50ppm | NMT 50ppm |
12 | Oxalate | Less than 300ppm | NMT 300ppm |
13 | Sulphate (SO4) | Less than 150ppm | NMT 150ppm |
14 | Water (By KF) | 11.7% | 11.0%-13.0% |
15 | Water (At 180°C for 18h) | 11.8% | 10.0% -13.0% |
16 | Assay (Anhydrous basis) | 100.2% | 99.0%-101.0% |
17 | Assay (on Anhydrous basis) | 100.0% | 99.0%-100.5% |
18 | Tartrates | Complies | No crystalline precipitate is formed. |
19 | Total aerobic microbial count | Less than 1000 CFU/gm | NMT 1000 CFU/gm |
20 | Total Yeast & mold count | Less than 100 CFU/gm | NMT 100 CFU/gm |
21 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm |
22 | E.coli | Absent/gm | should be absent/gm |
23 | Pseud. aeruginosa | Absent/gm | should be absent/gm |
24 | Staphylococcus aureus | Absent/gm | should be absent/gm |
25 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |