| Disodium Edetate USP/Ph.Eur CS2 25KG | |||
| 97660SK025 | 459059107DY | ||
| USP/Ph.Eur Customer specific 2 | 4590591 | ||
| 6381-92-6 | 111352 | ||
| C10H14N2Na2O8.2H2O | April 2025 | ||
| 372.24 | March 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance | White crystalline powder. | White crystalline powder. | USP/ Ph. Eur |
| 2 | Solubility | Complies | Soluble in water, practically insoluble in ethanol (96%) | Ph. Eur |
| 3 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of standard | USP/ Ph. Eur |
| 4 | Identification (By chemical test) | Complies | No precipitate should produce. | Ph. Eur |
| 5 | Appearance of Solution | Complies | Solution should be clear and colorless. | Ph. Eur |
| 6 | pH | 5.1 | 4.0-5.5 | USP/ Ph. Eur |
| 7 | Impurity A (Nitrilotriacetic acid) | 0.03% | 0.1% max | USP / Ph. Eur |
| 8 | Calcium (Ca) | Complies | No precipitate should form. | USP |
| 9 | Iron (Fe) | Less than 80 ppm | 80ppm max | Ph. Eur |
| 10 | Assay (on dried basis) | 99.8% | 99.0% - 101.0% | USP |
| 11 | Loss on drying at 150° for 6 Hr | 9.1% | 8.7%-11.4% | USP |
| 12 | Particle size | 98% Passes through 100 mesh. | NLT 95% Passes through 100 mesh |
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP AND PH.EUR 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.
