| Disodium succinate hexahydrate CDMF PARENTEX PLUS 500GM | |||
| I3691SG500 | 42036B408JW | ||
| CDMF PARENTEX PLUS | 42036B4 | ||
| 6106-21-4 | 98418 | ||
| C4H4Na2O4.6H2O | October 2023 | ||
| 270.14 | September 2025 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | White crystals. | White crystals or white powder. |
| 2 | Solubility | Complies | 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 (By HPLC, on dried basis) | 99.8% | 98.0% - 102.0% |
| 7 | Limit of Sodium Acetate | Not detected | NMT 0.2% |
| 8 | Limit of Sodium Maleate | 0.001% | NMT 0.1% |
| 9 | Limit of Sodium Fumarate | 0.001% | NMT 0.1% |
| 10 | Acidity & alkalinity /pH | 8.64 | 7.5 - 9.0 |
| 11 | Loss on drying,120°C | 40.6% | 37.0% to 41.0% |
| 12 | Chloride (Cl) | Less than 0.005% | NMT 0.005% |
| 13 | Sulphate (SO4) | Less than 0.01% | NMT 0.01% |
| 14 | Phosphate (PO4) | Less than 0.001% | NMT 0.001% |
| 15 | Nitrogen (N) | Less than 0.001% | NMT 0.001% |
| 16 | Arsenic (As) | Not detected | NMT 1.5ppm |
| 17 | Cadmium(Cd) | Not detected | NMT 0.2ppm |
| 18 | Lead (pb) | 0.27ppm | NMT 0.5ppm |
| 19 | Mercury(Hg) | Not detected | NMT 0.3ppm |
| 20 | Nickel (Ni) | Not detected | NMT 2ppm |
| 21 | Copper (Cu) | 0.0002% | NMT 0.0005% |
| 22 | Iron (Fe) | 0.0011% | NMT 0.002% |
| 23 | Potassium (K) | 0.0046% | NMT 0.05% |
| 24 | Calcium (Ca) | 0.0029% | NMT 0.005% |
| 25 | UV absorbance profile (10mm cell)@260nm | 0.044 | NMT 0.08 |
| 26 | UV absorbance profile (10mm cell)@280nm | 0.025 | NMT 0.045 |
| 27 | Total aerobic microbial count (Bioburden) | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 28 | Total combined yeasts and molds count (Bioburden) | Less than 50 CFU/gm | NMT 50 CFU/gm |
| 29 | E.coli | Absent/gm | should be absent /gm |
| 30 | Salmonella | Absent/10 gm | should be absent /10 gm |
| 31 | Pseud. aeruginosa | Absent/gm | should be absent /gm |
| 32 | Staphylococcus aureus | Absent/gm | should be absent /gm |
| 33 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent /gm |
| 34 | 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 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.
