| Fumaric acid USP-NF/JP 25KG | |||
| M7708SK025 | 49292J112FZ | ||
| USP-NF/JP | 49292J1 | ||
| 110-17-8 | 121381 | ||
| C4H4O4 | June 2026 | ||
| 116.07 | May 2029 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White crystalline powder. Melting point 290.5°C | White, granules , white crystals or crystalline powder. Metling point about 290°C. | USP-NF/JP |
| 2 | Solubility | Complies | Freely soluble in n.n-dimethylformamide, Soluble in methanol and .in ethanol (95%); slightly soluble in water and in ether, dissolve in ammonia TS and in sodium hydroxide TS | USP-NF/JP |
| 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 | Identification (Chemical test 1) | Complies | The solution should show green-blue fluorescence | JP |
| 6 | Identification (Chemical test 2) | Complies | The color of the test solution should disappears | JP |
| 7 | Identification (By UV absorbance test) | Complies | The solution should show absorption maxima between 204 nm to 208 nm. | JP |
| 8 | Clarity and colour of solution | Complies | The solution shoud clear and colorless | JP |
| 9 | Sulfate | Less than 0.010% | NMT 0.010% | JP |
| 10 | Heavy metals | Less than 10 ppm | NMT 10 ppm | JP |
| 11 | Arsenic | Less than 2 ppm | NMT 2 ppm | JP |
| 12 | Limit of Maleic acid | Not detected | NMT 0.1% | USP-NF/In-house |
| 13 | Limit of Malic acid | 0.1% | NMT1.5% | USP-NF/In-house |
| 14 | Water | 0.4% | NMT 0.5% | USP-NF/JP |
| 15 | Residue on ignition | 0.01% | NMT 0.05% | USP-NF/JP |
| 16 | Assay (By Titration,on anhydrous basis) | 99.8% | 99.5%-101.0% | JP |
| 17 | Assay (By HPLC, on anhydrous basis) | 99.9% | 98.0%-102% | USP-NF/In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF,JP SPECIFICATION.
Actylis 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.
