| 1 | Description | Off-white powder. It is hygroscopic. | White to off-white or light brownish crystals/powder or lumps. It is hydroscopic. | In-house |
| 2 | Solubility | Complies | Soluble in water & alcohol. | In-house |
| 3 | Identification by IR | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. | In-house |
| 4 | Chloride (Cl) | Less than 0.05% | NMT 0.05% | In-house |
| 5 | Moisture | 0.002% | NMT 2.0% | In-house |
| 6 | Assay (By Titration) | 98.6% | NLT 98.0% on anhydrous Basis | In-house |
| 7 | Residue on ignition | 0.002% | NMT 0.1% | In-house |
| 8 | Purity (By HPLC) | 99.97% | NLT 98.0% | In-house |
| 9 | Organic impurities; Diphenyl sulfone | 0.04% | NMT 2.0% | In-house |
| 10 | Organic impurities; Total impurities | 0.04% | NMT 2.0% | In-house |
| 11 | Cyclohexane as residual solvent | 9.4 ppm | NMT 2000 ppm | In-house |
| 12 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 13 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm | In-house |
| 14 | E.coli | Absent/gm | should be absent/gm | In-house |
| 15 | Salmonella | Absent/10 gm | should be absent/10 gm | In-house |
| 16 | Staphylococcus aureus | Absent/gm | should be absent/gm | In-house |
| 17 | Pseud. aeruginosa | Absent/gm | should be absent/gm | In-house |
| 18 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm | In-house |
| 19 | Bacterial endotoxins | Less than 2.5 EU/mg | NMT 2.5 EU/mg | In-house |