Disodium succinate hexahydrate HP PARENTEX PLUS 500GM | |||
I4691SG500 | 37293B323CV | ||
HP PARENTEX PLUS | 37293B3 | ||
6106-21-4 | 87204 | ||
C4H4Na2O4.6H2O | March 2022 | ||
270.14 | February 2024 | ||
Sr.No. | Test | Result | Specification |
---|---|---|---|
1 | Appearance | White crystalline powder | White crystalline powder |
2 | Solubility | Complies | Freely soluble in water |
3 | Assay (on dry basis) | 99.80% | NLT 98.0% |
4 | Identification by IR | Complies | IR spectra of the sample should be concomitant with the IR spectra of the respective standard. |
5 | Identification by Chemical test | Complies | Dense white precipitate should form |
6 | pH(5% aq soln) | 8.9 | 7.50 to 9.00 |
7 | Loss on drying,120°C | 39.7% | 39.0% to 41.0% |
8 | Chloride (Cl) | Less than 0.005% | NMT 0.005% |
9 | Sulphate (SO4) | Less than 0.01% | NMT 0.01% |
10 | Phosphate (PO4) | Less than 0.001% | NMT 0.001% |
11 | Nitrogen (N) | Less than 0.001% | NMT 0.001% |
12 | Heavy metals | Less than 0.001% | NMT 0.001% |
13 | Arsenic (As) | Not detected | NMT 1.5ppm |
14 | Cadmium(Cd) | Not detected | NMT 0.2ppm |
15 | Lead (Pb) | Not detected | NMT 0.5ppm |
16 | Mercury(Hg) | Not detected | NMT 0.3ppm |
17 | Calcium (Ca) | Not detected | NMT 0.005% |
18 | Copper (Cu) | Not detected | NMT 0.0005% |
19 | Iron (Fe) | Not detected | NMT 0.002% |
20 | Potassium (K) | Not detected | NMT 0.05% |
21 | Nickel (Ni) | Not detected | NMT 2ppm |
22 | UV absorbance profile (10mm cell)@260nm | 0.056 | NMT 0.08 |
23 | UV absorbance profile (10mm cell)@280nm | 0.031 | NMT 0.045 |
24 | Total aerobic microbial count (Bioburden) | Less than 100 CFU/gm | NMT 100 CFU/gm |
25 | Total combined yeasts and molds count (Bioburden) | Less than 50 CFU/gm | NMT 50 CFU/gm |
26 | E.coli | Absent/gm | should be absent/gm |
27 | Salmonella | Absent/10gm | should be absent/10gm |
28 | Pseud. aeruginosa | Absent/gm | should be absent/gm |
29 | Staphylococcus aureus | Absent/gm | should be absent/gm |
30 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
31 | Bacterial endotoxins | Less than 6 EU/gm | NMT 6 EU/gm |
Tested By (Chemist - Quality Control) | Approved By (Head - Quality Control) |