Disodium succinate hexahydrate HP 100GM | |||
81691SG100 | 259143514FR | ||
HP | 2591435 | ||
6106-21-4 | 46402 | ||
C4H4Na2O4.6H2O | June 2018 | ||
270.14 | May 2020 | ||
Sr.No. | Test | Result | Specification |
---|---|---|---|
1 | Appearance | White crystalline powder. | White crystalline powder |
2 | Solubility | Passes | 20% solution in water is clear and colourless. |
3 | Assay (on dry basis) | 99.74% | Min. 98.0% |
4 | Identification by IR | Complies | To Comply the test |
5 | Identification by Chemical test | Complies | To Comply the test for Sodium ion |
6 | pH(5% aq soln) | 8.77 | 7.50 to 9.00 |
7 | Loss on drying,120°C | 40.95% | 39.0% to 41.0% |
8 | Chloride (Cl) | NMT 0.005% | 0.005% max |
9 | Sulphate (SO4) | NMT 0.01% | 0.01% max |
10 | Phosphate (PO4) | NMT 0.001% | 0.001% max |
11 | Nitrogen (N) | NMT 0.001% | 0.001% max |
12 | Heavy metals | NMT 0.001% | 0.001% max |
13 | Arsenic (As) | B.L.Q.(Q.L.=0.05) | 1.5ppm max |
14 | Cadmium(Cd) | B.L.Q.(Q.L.=0.05) | 0.2ppm max |
15 | Lead (Pb) | B.L.Q.(Q.L.=0.05) | 0.5ppm max |
16 | Mercury(Hg) | B.L.Q.(Q.L.=0.05) | 0.3ppm max |
17 | Calcium (Ca) | Not detected | 0.005% max |
18 | Copper (Cu) | Not detected | 0.0005% max |
19 | Iron (Fe) | Not detected | 0.002% max |
20 | Potassium (K) | 0.0038% | 0.05% max |
21 | Nickel (Ni) | Not detected | 2ppm max |
22 | UV absorbance profile (10mm cell)@260nm | 0.052 | 0.08 max |
23 | UV absorbance profile (10mm cell)@280nm | 0.031 | 0.045 max |
24 | Total aerobic microbial count (Bioburden) | Absent | 100 cfu/g max |
25 | Total combined yeasts and molds count (Bioburden) | 5 cfu/g | 50 cfu/g max |
26 | E.coli | Absent | Absent cfu/gm |
27 | Salmonella | Absent | Absent cfu/ 10gm |
28 | Pseud. aeruginosa | Absent | Absent cfu/gm |
29 | Staphylococcus aureus | Absent | Absent cfu/gm |
30 | Bile-tolerant gram negative bacteria | Absent | Absent cfu/gm |
31 | Bacterial endotoxins | Complies | 6 EU/gm max |
Tested By (Chemist - Quality Control) | Approved By (Head - Quality Control) |