1 | Appearance/Description | White crystalline powder. | White crystalline powder. |
2 | Solubility | Complies | Soluble in water, practically insoluble in ethanol (96%). |
3 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of standard. |
4 | Identification (By chemical test 1) | Complies | No precipitate should formed. |
5 | Identification (By chemical test 2) | Complies | No precipitate should formed. |
6 | Identification (By chemical test 3) | Complies | The red color should discharged, leaving a yellowish solution. |
7 | Identification (By chemical test 4) | Complies | A dense white precipitate should formed. |
8 | Appearance of Solution / Clarity and color of solution | Complies | Solution should be clear and colorless. |
9 | pH / Acidity | 4.51 | 4.0 – 5.0 |
10 | Impurity A (Nitrilotriacetic acid) | 0.01% | NMT 0.1% |
11 | Calcium (Ca) | Complies | No precipitate should formed. |
12 | Assay (on dried basis) | 99.7% | 99.0% – 101.0% |
13 | Loss on drying at 150° for 6 Hr | 9.8% | 8.7% – 11.4% |
14 | Chelating capacity test | Complies | Test solution with Solution 1 should be clear. Test solution with Solution 2 should be light blue and should not be any red. |
15 | Chlorides | Less than 0.004% | NMT 0.004% |
16 | Iron | Less than 0.002% | NMT 0.002% |
17 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
18 | Total Yeast & mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
19 | Escherichia coli | Absent/gm | should be Absent/gm |
20 | Pseud. aeruginosa | Absent/gm | should be Absent/gm |
21 | Staphylococcus aureus | Absent/gm | should be Absent/gm |
22 | Bile-tolerant gram negative bacteria | Absent/gm | should be Absent/gm |
23 | Salmonella | Absent/10gm | should be Absent/10gm |
24 | Bacterial endotoxins | Less than 30 EU/gm | NMT 30 EU/gm |