1 | Description | Off-white crystals. It is hygroscopic. | White to off-white or light brownish crystals/powder or lumps. It is hydroscopic. |
2 | Solubility | Complies | 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 | 1.37% | NMT 2.0% |
6 | Assay (By Titration) | 99.3% | NLT 98.0% on anhydrous Basis |
7 | Residue on ignition | 0.009% | NMT 0.1% |
8 | Purity (By HPLC) | 99.99% | NLT 98.0% |
9 | Organic impurities; Diphenyl sulfone | Not detected | NMT 2.0% |
10 | Organic impurities; Total impurities | 0.009% | NMT 2.0% |
11 | Cyclohexane as residual solvent | 36 ppm | NMT 2000 ppm |
12 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
13 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm |
14 | E.coli | Absent/gm | should be absent/gm |
15 | Salmonella | Absent/10 gm | should be absent/10 gm |
16 | Staphylococcus aureus | Absent/gm | should be absent/gm |
17 | Pseud. aeruginosa | Absent/gm | should be absent/gm |
18 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
19 | Bacterial endotoxins | Less than 2.5 EU/mg | NMT 2.5 EU/mg |