| Malic acid USP-NF/Ph.Eur PS-40 5KG | |||
| S1A864K005 | 43009K324BX | ||
| USP-NF/Ph.Eur PS-40 | 43009K3 | ||
| 617-48-1 | 102917 | ||
| C4H6O5 | February 2024 | ||
| 134.09 | January 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | White crystalline powder,Melts at 131°C | White or practically white or almost white, crystalline powder or granules. 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) | 131.0°C | 128.0°C - 132.0°C |
| 5 | Appearance of solution | Complies | Clear and colourless. |
| 6 | Assay | 99.8% | 99.0% - 100.5% of C4H6O5. |
| 7 | Assay (anhydrous substance) | 99.9% | 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 /Sulfated ash | 0.04% | NMT 0.1% |
| 11 | Related substances: Impurity A (Fumaric acid) | 0.9% | NMT 1.0 % |
| 12 | Related substances: Impurity B (Maleic acid) | 0.02% | NMT 0.05% |
| 13 | Related substances: Any other impurity | 0.02% | NMT 0.1% |
| 14 | Related substances: Total of other impurities | 0.03% | NMT 0.5% |
| 15 | Water | 0.08% | NMT 2.0% |
| 16 | Particle size | Complies | 100 % passes through 40mesh, NLT 55% retain on 60 mesh, NMT 85% retain on 80 mesh,and NLT 98% retain on 140mesh. |
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.
