| Docusate sodium CPH1 5KG | |||
| 14628SR500 | 220874617EQ | ||
| Customised pharma grade 1 | 2208746 | ||
| 577-11-7 | 36573 | ||
| C20H37NaO7S | May 2017 | ||
| 444.56 | April 2020 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White, wax like plastic solid, having a characteristic odor suggestive of octyl alcohol but no odor of other solvents. | White, wax like plastic solid, having a characteristic odor suggestive of octyl alcohol but no odor of other solvents. |
| 2 | Solubility | Passes | Very soluble in solvent hexane, freely soluble in alcohol and in glycerin, sparingly soluble in water. |
| 3 | Identification by IR | Complies | To comply the test |
| 4 | Assay (Anhydrous basis) | 99.28% | 99.0%-100.5% of C20¬H37¬NaO7S |
| 5 | Residue on ignition | 15.8% | 15.5%-16.5% |
| 6 | Heavy metals | NMT 10ppm | NMT 10ppm |
| 7 | Organic impurities: (Limit of Bis (2-Ethylhexyl) Maleate | 0.14% | NMT 0.4% |
| 8 | Water (By KF) | 1.49% | NMT 2.0% |
| 9 | Clarity of solution | Passes | The sample solution does not develop a haze within 24 hrs. |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP 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.
