1 | Description | Off-white to white waxy crystalline solid. | Off-white to white waxy crystalline solid. |
2 | Solubility | Passes | Soluble in water & alcohol. |
3 | Identification by IR | Complies | To comply the test |
4 | Melting point | 60°C | 59°C-61°C |
5 | Chloride (Cl) | Less than 0.05% | Not more than 0.05% |
6 | Moisture | 0.04% | 1.0% max |
7 | Assay(HPLC) | 99.4% | Min. 98.0% (Anhydrous basis) |
8 | Residue on ignition | 0.03% | 0.1% max |
9 | Organic impurities; Diphenyl sulfone | 0.06% | Not more than 2.0% |
10 | Organic impurities; Total impurities | 1.0% | Not more than 2.0% |
11 | Iron (Fe) | 0.0004% | 0.002% max |
12 | Arsenic (As) | Not detected | 0.15ppm max |
13 | Lead (Pb) | 0.1ppm | 0.5ppm max |
14 | Mercury(Hg) | Not detected | 0.15ppm max |
15 | Cadmium(Cd) | Not detected | 0.2 ppm max |
16 | Total aerobic microbial count | Less than 100 cfu/gm | 100 cfu/gm max |
17 | Total combined yeast and molds count | Less than 10 cfu/gm | 10 cfu/gm max |
18 | E.coli | Absent/gm | Absent/gm |
19 | Salmonella | Absnt/10 gm | Absent/10 gm |
20 | Staphylococcus aureus | Absent/gm | Absent/gm |
21 | Pseud. aeruginosa | Absent/gm | Absent/gm |
22 | Bile-tolerant gram negative bacteria | Absent/gm | Absent/gm |
23 | Bacterial endotoxins | Less than 2.5 EU/mg | 2.5 EU/mg max |
24 | Cyclohexane as residual solvent | Not detected | 2000 ppm max |
25 | Residual solvent (ICH) | Complies | To Comply the test |