| 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 |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION.
FINAR provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
| Tested By (Chemist - Quality Control) | Approved By (Head - Quality Control) |
Computer Generated Report - Does not require Signature.
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