| Fumaric acid CDMF 500G | |||
| 92708SG500 | 48894D201EZ | ||
| CDMF | 48894D2 | ||
| 110-17-8 | 121456 | ||
| C4H4O4 | May 2026 | ||
| 116.07 | April 2029 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White, odorless crystalline powder. | White, or almost white odorless granules or crystalline powder. | USP-NF/CP |
| 2 | Solubility | Complies | Soluble in alcohol; slightly soluble in water and in ether. | USP-NF |
| 3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. | USP-NF/CP |
| 4 | Identification B (By chemical test) | Complies | The colour of bromide should be faded. | CP |
| 5 | Identification C (By HPLC) | 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. | In-house |
| 6 | Identification D (By HPLC) | Complies | The retention time of the principal peak in the chromatogram of the test solution corresponds to that of the principal peak in the chromatogram of the reference solution. | CP |
| 7 | Limit of Maleic acid | Not detected | NMT 0.1% | In-house |
| 8 | Limit of Malic acid | 0.08% | NMT 1.5% | In-house |
| 9 | Maleic acid | 0.003% | NMT 0.1% | CP |
| 10 | Any other individual impurity | 0.01% | NMT 0.1% | CP |
| 11 | Total impurities | 0.01% | NMT 0.2% | CP |
| 12 | Residue on ignition | 0.01% | NMT 0.1% | USP-NF/CP |
| 13 | Heavy metals | Less than 0.001% | 0.001% | CP |
| 14 | Water | 0.4% | NMT 0.5% | USP-NF/CP |
| 15 | Assay (Anhydrous basis) | 99.9% | 98.0%-102.0% | In-house |
| 16 | Assay (on anhydrous basis) | 99.8% | NLT 99.0% | CP |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE 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.
