| Fumaric acid Excipient grade 25KG | |||
| 80708SK025 | 322981707GT | ||
| Excipient Grade | 3229817 | ||
| 110-17-8 | 65543 | ||
| C4H4O4 | July 2020 | ||
| 116.07 | June 2023 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White crystalline powder. | White to off-white crystalline powder. |
| 2 | Identification (By chemical test) | Complies | A precipitate is formed in the blue solution within 1 min. |
| 3 | Identification (By IR) | Complies | The infrared absorption spectrum of the preparation of the test sample exhibits maxima only at the same wave numbers as that of a similar preparation of working standard/reference standard. |
| 4 | Water content (By KF titration, w/w) | 0.39% | Not more than 0.5% |
| 5 | Residue on ignition ( w/w) | 0.04% | Not more than 0.1% |
| 6 | Heavy metals | Less than 10ppm | Not more than 10ppm |
| 7 | Assay by HPLC (On anhydrous basis w/w) | 99.9% | Not less than 98.5% and Not more than 101.5% |
| 8 | Related Substance : Maleic Acid | 0.01% | Not more than 0.1% |
| 9 | Related substances: unspecified impurity | 0.05% | Not more than 0.1% |
| 10 | Related substances, total impurities | 0.06% | Not more than 0.5% |
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.
