| Disodium Edetate USP/Ph.Eur 5KG | |||
| 93660SR500 | 474017105JY | ||
| USP/Ph.Eur | 4740171 | ||
| 6381-92-6 | 116224 | ||
| C10H14N2Na2O8.2H2O | October 2025 | ||
| 372.24 | September 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | White crystalline powder. | White or almost white crystalline powder. | USP/ Ph. Eur |
| 2 | Solubility | Complies | Soluble in water, practically insoluble in ethanol (96%) | USP/ Ph. Eur |
| 3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of standard | USP/ Ph. Eur |
| 4 | Identification B (By Chemical test 1) | Complies | No yellow precipitate should form. | Ph. Eur |
| 5 | Identification B (By Chemical test 2) | Complies | No precipitate should form. | Ph. Eur |
| 6 | Identification B (By Chemical test 3) | Complies | The red color should discharge, leaving a yellowish solution. | USP |
| 7 | Identification C (By Chemical test) | Complies | No precipitate should form. | Ph. Eur |
| 8 | Identification (For sodium test A) | Complies | A dense white precipitate should form. | USP/ Ph. Eur |
| 9 | Appearance of Solution | Complies | Solution S should be clear and colorless. | Ph. Eur |
| 10 | pH | 4.36 | 4.0-5.5 | USP/ Ph. Eur |
| 11 | Impurity A (Nitrilotriacetic acid) | 0.019% | NMT 0.1% | USP / Ph. Eur |
| 12 | Calcium (Ca) | Complies | No precipitate should form. | USP |
| 13 | Iron (Fe) | Less than 80 ppm | NMT 80ppm | Ph. Eur |
| 14 | Assay (on dried basis) | 99.61% | 99.0% - 101.0% | USP |
| 15 | Assay | 99.52% | 98.5%-101.0% | Ph.Eur |
| 16 | Loss on drying at 150° for 6 Hr | 9.19% | 8.7%-11.4% | USP |
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.
