CASR |
: | ------ |
Molecular Formula |
: | ------ |
Molecular Weight |
: | ------ |
| Specifications | |
|---|---|
| Appearance/Description: | White crystals / crystalline powder. |
| Solubility: | Freely soluble in water. |
| 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 the sample solution corresponds to that of the standard solution. |
| Identification C (for Sodium): | Dense white precipitate should form. |
| Assay (By HPLC, on dried basis): | 98.0% - 102.0% |
| Limit of Sodium Acetate: | NMT 0.2% |
| Limit of Sodium Maleate: | NMT 0.1% |
| Limit of Sodium Fumarate: | NMT 0.1% |
| Acidity & alkalinity /pH: | 7.5 - 9.0 |
| Loss on drying,120°C: | 37.0% to 41.0% |
| Chloride (Cl): | 0.005% max. |
| Sulphate (SO4): | 0.01% max. |
| Phosphate (PO4): | 0.001% max. |
| Nitrogen (N): | 0.001% max. |
| Arsenic (As): | 1.5ppm max. |
| Cadmium(Cd): | 0.2ppm max. |
| Lead (pb): | 0.5ppm max. |
| Mercury(Hg): | 0.3ppm max. |
| Nickel (Ni): | 2ppm max. |
| Copper (Cu): | 0.0005% max. |
| Iron (Fe): | 0.002% max. |
| Potassium (K): | 0.05% max. |
| Calcium (Ca): | 0.005% max. |
| UV absorbance profile (10mm cell)@260nm: | 0.08 max. |
| UV absorbance profile (10mm cell)@280nm: | 0.045 max. |
| Total aerobic microbial count (Bioburden): | 100 CFU/g max. |
| Total combined yeasts and molds count (Bioburden): | 50 CFU/g max. |
| E.coli: | Absent CFU/gm |
| Salmonella: | Absent CFU/ 10gm |
| Pseud. aeruginosa: | Absent CFU/gm |
| Staphylococcus aureus: | Absent CFU/gm |
| Bile-tolerant gram negative bacteria: | Absent CFU/gm |
| Bacterial endotoxins: | 6 EU/gm max. |
