1 | Description | Off-white powder. | White to off - white crystals/powder with lumps. |
2 | Solubility | Passes | Soluble in water & alcohol. |
3 | Identification by IR | Complies | To comply the test |
4 | Chloride (Cl) | Less than 0.05% | Not more than 0.05% |
5 | Moisture | 0.04% | 1.0% max |
6 | Assay | 99.2% | Min 98.0% (Anhyrous basis) |
7 | Related substances: Any unknown impurity | 0.03% | NMT 0.10% |
8 | Related substances: Total impurity | 0.5% | NMT 2.0% |
9 | Benzene | 0.3 ppm | NMT 2 ppm |
10 | Clarity and colour of solution | Passes | The solution is clear and colourless, any colour produced is not more intense than reference solution B7 (EP reference solution). |
11 | Residue on ignition | 0.05% | 0.1% max |
12 | Iron (Fe) | 0.0005% | 0.002% max |
13 | Arsenic (As) | B.L.Q.(Q.L.=0.02) | 0.15ppm max |
14 | Lead (Pb) | 0.10ppm | 0.5ppm max |
15 | Mercury(Hg) | B.L.Q.(Q.L.=0.02) | 0.15ppm max |
16 | Cadmium(Cd) | B.L.Q.(Q.L.=0.02) | 0.2 ppm max |
17 | Total aerobic microbial count | Less than 100 cfu/gm | 100 cfu/gm max |
18 | Total combined yeast and molds count | Less than 10 cfu/gm | 10 cfu/gm max |
19 | E.coli | Absent/gm | Absent/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 | Methyl benzene Sulfonate | Not detected | NMT 134.8 ppm |