| Malic acid USP-NF/Ph.Eur 5KG | |||
| 97864SR500 | 42848H611BX | ||
| USP-NF/Ph.Eur | 42848H6 | ||
| 617-48-1 | 101918 | ||
| C4H6O5 | February 2024 | ||
| 134.09 | January 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White crystalline powder. having a strongly acid. Melts at 130.4°C | White or practically white, crystalline powder or granules, having a strongly acid. Melts at about 130°C. |
| 2 | Solubility | Complies | Very soluble in water; freely soluble in alcohol and Sparingly soluble in acetone. |
| 3 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. |
| 4 | Identification (By Melting point) | 130.4°C | 128.0°C - 132.0°C |
| 5 | Appearance of solution | Complies | Clear and colourless. |
| 6 | Assay | 99.8% | 99.0% - 100.5% |
| 7 | Assay (anhydrous substance) | 100.0% | 99.0% to 101.0% |
| 8 | Optical Rotation | 0.00° | -0.10° to + 0.10° |
| 9 | Water insoluble substances | 0.007% | NMT 0.1% |
| 10 | Residue on ignition | 0.02% | NMT 0.1% |
| 11 | Related substances: Impurity A (Fumaric acid) | 0.9% | NMT 1.0 % |
| 12 | Related substances: Impurity B (Maleic acid) | 0.027% | NMT 0.05% |
| 13 | Related substances: Any other impurity | Not detected | NMT 0.1% |
| 14 | Related substances: Total impurity | Not detected | NMT 0.5% |
| 15 | Water | 0.2% | NMT 2.0% |
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP-NF AND PH.EUR 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.
