| Docusate sodium CPH1 500GM | |||
| 14628SG500 | 294334609GS | ||
| Customised pharma grade 1 | 2943346 | ||
| 577-11-7 | 56619 | ||
| C20H37NaO7S | July 2019 | ||
| 444.56 | June 2022 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White, waxy 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 | IR spectra of the sample should be concomitant with IR spectra of the standard |
| 4 | Assay (Anhydrous basis) | 99.37% | 99.0%-100.5% |
| 5 | Residue on ignition | 15.91% | 15.5%-16.5% |
| 6 | Organic impurities: (Limit of Bis (2-Ethylhexyl) Maleate | Less than 0.4% | NMT 0.4% |
| 7 | Water (By KF) | 1.91% | NMT 2.0% |
| 8 | Clarity of solution | Passes | The sample solution should 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.
