
| Fumaric acid USP-NF 500G | |||
| 90708SG500 | 495290809GZ | ||
| USP-NF | 4952908 | ||
| 110-17-8 | 122076 | ||
| C4H4O4 | July 2026 | ||
| 116.07 | June 2029 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White , odorless granules powder | White, odorless granules or crystalline powder. | USP-NF |
| 2 | Solubility | Complies | Soluble in alcohol; slightly soluble in water and in ether. | USP-NF |
| 3 | Identification by IR | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. | USP-NF |
| 4 | Identification (By Chromatogram) | Complies | The retention time of the fumaric acid peak of the sample solution corresponds to that of the standard solution as obtained in the assay. | USP-NF/In-house |
| 5 | Assay (Anhydrous basis) | 99.8% | 98.0% - 102.0% | In-house |
| 6 | Residue on ignition | 0.04% | NMT 0.1% | USP-NF |
| 7 | Limit of Maleic acid | 0.01% | NMT 0.1% | In-house |
| 8 | Limit of Malic acid | Not detected | NMT 1.5% | In-house |
| 9 | Water | 0.47% | NMT 0.5% | USP-NF |
| Tested By (Chemist - Quality Control) | Approved By (Head - Quality Control) |