| Disodium succinate hexahydrate HP PARENTEX PLUS 500GM | |||
| I4691SG500 | 41424B325GW | ||
| HP PARENTEX PLUS | 41424B3 | ||
| 6106-21-4 | 96787 | ||
| C4H4Na2O4.6H2O | July 2023 | ||
| 270.14 | June 2025 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | White crystals | White crystals or white powder |
| 2 | Solubility | Complies | Freely soluble in water |
| 3 | Assay (on dried basis) | 99.75% | 98.0% - 102.0% |
| 4 | Identification B (By Chromatographic identity) | Complies | The retention time of the major peak of sample solution corresponds to that of the standrad solution. |
| 5 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with the IR spectra of the respective standard. |
| 6 | Identification C (for Sodium) | Complies | Dense white precipitate should form |
| 7 | Acidity & alkalinity | 8.8 | 7.0 - 9.0 |
| 8 | Loss on drying (120°C for 2hr) | 40.34% | 37.0% - 41.0% |
| 9 | Limit of Sodium Acetate | Not detected | NMT 0.2% |
| 10 | Limit of Sodium Fumarate | 0.001% | NMT 0.1% |
| 11 | Limit of Sodium Maleate | 0.001% | NMT 0.1% |
| 12 | Chloride (Cl) | Less than 0.005% | NMT 0.005% |
| 13 | Sulphate (SO4) | Less than 0.019% | NMT 0.019% |
| 14 | UV absorbance profile (10mm cell)@260nm | 0.049 | NMT 0.08 |
| 15 | UV absorbance profile (10mm cell)@280nm | 0.035 | NMT 0.045 |
| 16 | Total aerobic microbial count (Bioburden) | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 17 | Total combined yeasts and molds count (Bioburden) | Less than 50 CFU/gm | NMT 50 CFU/gm |
| 18 | E.coli | Absent/gm | should be absent/gm |
| 19 | Salmonella | Absent/10gm | should be absent/10gm |
| 20 | Pseud. aeruginosa | Absent/gm | should be absent/gm |
| 21 | Staphylococcus aureus | Absent/gm | should be absent/gm |
| 22 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
| 23 | Bacterial endotoxins | Less than 6.0 EU/gm | NMT 6.0 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.
