1 | Description | Off-white powder with lumps. | White to off - white crystals/powder with lumps. |
2 | Solubility | Passes | Soluble in water & alcohol. |
3 | Identification by IR | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. |
4 | Chloride (Cl) | Less than 0.05% | NMT 0.05% |
5 | Moisture | 0.1% | NMT 1.0% |
6 | Assay | 99.2% | NLT 98.0% (Anhyrous basis) |
7 | Related substances: Any unknown impurity | Not detected | NMT 0.10% |
8 | Related substances: Total impurity | Not detected | NMT 2.0% |
9 | Benzene | 0.1 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 | 0.04% | NMT 0.1% |
12 | Iron (Fe) | 0.0004% | NMT 0.002% |
13 | Arsenic (As) | Not detected | NMT 0.15ppm |
14 | Lead (Pb) | 0.1ppm | NMT 0.5ppm |
15 | Mercury(Hg) | Not detected | NMT 0.15ppm |
16 | Cadmium(Cd) | Not detected | NMT 0.2 ppm |
17 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
18 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm |
19 | E.coli | Absent/gm | should be absent/gm |
20 | Staphylococcus aureus | Absent/gm | should be absent/gm |
21 | Pseud. aeruginosa | Absent/gm | should be absent/gm |
22 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
23 | Bacterial endotoxins | Less than 2.5 EU/mg | NMT 2.5 EU/mg |
24 | Cyclohexane as residual solvent | 757 ppm | NMT 2000 ppm |
25 | Methyl benzene Sulfonate | 16 ppm | NMT 134.8 ppm |