| Disodium succinate hexahydrate USP-NF PARENTEX PLUS 100GM | |||
| I7691SG100 | 36618F730LU | ||
| USP-NF PARENTEX PLUS | 36618F7 | ||
| 6106-21-4 | 81713 | ||
| C4H4Na2O4.6H2O | December 2021 | ||
| 270.14 | November 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | White powder | White crystals or white 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 (on dried basis) | 99.63% | 98.0%-102.0% |
| 7 | Limit of Sodium Acetate | Not detected | NMT 0.2% |
| 8 | Limit of Sodium Maleate | Not detected | NMT 0.1% |
| 9 | Limit of Sodium Fumarate | Not detected | NMT 0.1% |
| 10 | sulfate (as SO4) | Less than 0.019% | NMT 0.019% |
| 11 | Acidity & alkalinity | 8.89 | 7.0-9.0 |
| 12 | Loss on drying (120°C for 2hr) | 39.5% | 37.0%-41.0% |
| 13 | Total aerobic microbial count (Bioburden) | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 14 | Total combined yeasts and molds count (Bioburden) | Less than 50 CFU/gm | NMT 50 CFU/gm |
| 15 | E.coli | Absent/gm | should be absent /gm |
| 16 | Salmonella | Absent/10 gm | should be absent /10 gm |
| 17 | Pseud. aeruginosa | Absent/gm | should be absent /gm |
| 18 | Staphylococcus aureus | Absent/gm | should be absent /gm |
| 19 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent /gm |
| 20 | 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 AS WELL AS USP-NF 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.
