CASR |
: | ------ |
Molecular Formula |
: | ------ |
Molecular Weight |
: | ------ |
| Specifications | |
|---|---|
| Appearance: | White crystals or white powder |
| Solubility: | Freely soluble in water |
| Assay (on dried basis): | 98.0% - 102.0% |
| Identification A (By IR): | IR spectra of the sample should be concomitant with the IR spectra of the respective standard. |
| Identification B (By Chromatographic identity): | The retention time of the major peak of sample solution corresponds to that of the standrad solution. |
| Identification C (for Sodium): | Dense white precipitate should form |
| Acidity & alkalinity: | 7.0 - 9.0 |
| Loss on drying (120°C for 2hr): | 37.0% - 41.0% |
| Limit of Sodium Acetate: | NMT 0.2% |
| Limit of Sodium Fumarate: | NMT 0.1% |
| Limit of Sodium Maleate: | NMT 0.1% |
| Chloride (Cl): | NMT 0.005% |
| Sulphate (SO4): | NMT 0.019% |
| UV absorbance profile (10mm cell)@260nm: | NMT 0.08 |
| UV absorbance profile (10mm cell)@280nm: | NMT 0.045 |
| Total aerobic microbial count (Bioburden): | NMT 100 CFU/gm |
| Total combined yeasts and molds count (Bioburden): | NMT 50 CFU/gm |
| E.coli: | should be absent/gm |
| Salmonella: | should be absent/10gm |
| Pseud. aeruginosa: | should be absent/gm |
| Staphylococcus aureus: | should be absent/gm |
| Bile-tolerant gram negative bacteria: | should be absent/gm |
| Bacterial endotoxins: | NMT 6.0 EU/gm |
