1 | Appearance/Description | White crystalline powder. | White crystals / crystalline powder. |
2 | Solubility | Passes | Freely soluble in water. |
3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with the IR spectra of the respective standard. |
4 | Identification B (By Chromatographic identity) | Complies | The retention time of the major peak of the sample solution corresponds to that of the standard solution. |
5 | Identification C (for Sodium) | Complies | Dense white precipitate should form. |
6 | Assay (By HPLC, on dried basis) | 98.95% | 98.0% - 102.0% |
7 | Limit of Sodium Acetate | Not detected | NMT 0.2% |
8 | Limit of Sodium Maleate | 0.001% | NMT 0.1% |
9 | Limit of Sodium Fumarate | 0.001% | NMT 0.1% |
10 | Acidity & alkalinity /pH | 8.54 | 7.5 - 9.0 |
11 | Loss on drying,120°C | 40.2% | 37.0% to 41.0% |
12 | Chloride (Cl) | Less than 0.005% | 0.005% max. |
13 | Sulphate (SO4) | Less than 0.01% | 0.01% max. |
14 | Phosphate (PO4) | Less than 0.001% | 0.001% max. |
15 | Nitrogen (N) | Less than 0.001% | 0.001% max. |
16 | Arsenic (As) | B.L.Q.(Q.L.=0.05) | 1.5ppm max. |
17 | Cadmium(Cd) | B.L.Q.(Q.L.=0.05) | 0.2ppm max. |
18 | Lead (pb) | 0.11ppm | 0.5ppm max. |
19 | Mercury(Hg) | B.L.Q.(Q.L.=0.05) | 0.3ppm max. |
20 | Nickel (Ni) | 0.46ppm | 2ppm max. |
21 | Copper (Cu) | B.L.Q.(Q.L.=0.0001) | 0.0005% max. |
22 | Iron (Fe) | 0.0006% | 0.002% max. |
23 | Potassium (K) | 0.032% | 0.05% max. |
24 | Calcium (Ca) | 0.0024% | 0.005% max. |
25 | UV absorbance profile (10mm cell)@260nm | 0.056 | 0.08 max. |
26 | UV absorbance profile (10mm cell)@280nm | 0.027 | 0.045 max. |
27 | Total aerobic microbial count (Bioburden) | Absent | 100 CFU/g max. |
28 | Total combined yeasts and molds count (Bioburden) | Absent | 50 CFU/g max. |
29 | E.coli | Absent | Absent CFU/gm |
30 | Salmonella | Absent | Absent CFU/ 10gm |
31 | Pseud. aeruginosa | Absent | Absent CFU/gm |
32 | Staphylococcus aureus | Absent | Absent CFU/gm |
33 | Bile-tolerant gram negative bacteria | Absent | Absent CFU/gm |
34 | Bacterial endotoxins | Complies | 6 EU/gm max. |