1 | Appearance | White crystals | White crystals or white powder |
2 | Solubility | Complies | Freely soluble in water |
3 | Assay (on dried basis) | 99.75% | 98.0% - 102.0% |
4 | Identification B (By Chromatographic identity) | Complies | The retention time of the major peak of sample solution corresponds to that of the standrad solution. |
5 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with the IR spectra of the respective standard. |
6 | Identification C (for Sodium) | Complies | Dense white precipitate should form |
7 | Acidity & alkalinity | 8.8 | 7.0 - 9.0 |
8 | Loss on drying (120°C for 2hr) | 40.34% | 37.0% - 41.0% |
9 | Limit of Sodium Acetate | Not detected | NMT 0.2% |
10 | Limit of Sodium Fumarate | 0.001% | NMT 0.1% |
11 | Limit of Sodium Maleate | 0.001% | NMT 0.1% |
12 | Chloride (Cl) | Less than 0.005% | NMT 0.005% |
13 | Sulphate (SO4) | Less than 0.019% | NMT 0.019% |
14 | UV absorbance profile (10mm cell)@260nm | 0.049 | NMT 0.08 |
15 | UV absorbance profile (10mm cell)@280nm | 0.035 | NMT 0.045 |
16 | Total aerobic microbial count (Bioburden) | Less than 100 CFU/gm | NMT 100 CFU/gm |
17 | Total combined yeasts and molds count (Bioburden) | Less than 50 CFU/gm | NMT 50 CFU/gm |
18 | E.coli | Absent/gm | should be absent/gm |
19 | Salmonella | Absent/10gm | should be absent/10gm |
20 | Pseud. aeruginosa | Absent/gm | should be absent/gm |
21 | Staphylococcus aureus | Absent/gm | should be absent/gm |
22 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
23 | Bacterial endotoxins | Less than 6.0 EU/gm | NMT 6.0 EU/gm |