| Disodium Edetate USP/Ph.Eur PARENTEX 500GM | |||
| P0660SG500 | 42834B513BX | ||
| USP/Ph.Eur PARENTEX | 42834B5 | ||
| 6381-92-6 | 102361 | ||
| C10H14N2Na2O8.2H2O | February 2024 | ||
| 372.24 | January 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | White crystalline powder. | White crystalline powder. |
| 2 | Solubility | Complies | Soluble in water, practically insoluble in ethanol (96%) |
| 3 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR standard |
| 4 | Identification (By chemical test 1) | Complies | No precipitate should produce |
| 5 | Identification (By chemical test 2) | Complies | No precipitate should produce |
| 6 | Identification (By chemical test 3) | Complies | The red color should discharge, leaving a yellowish solution. |
| 7 | Identification (By chemical test 4) | Complies | A dense white precipitate should form |
| 8 | Appearance of solution | Complies | Solution should be clear and colorless. |
| 9 | pH | 4.66 | 4.0-5.5 |
| 10 | Impurity A (Nitrilotriacetic acid) | 0.02% | NMT 0.1 % |
| 11 | Calcium (Ca) | Complies | No precipitate should form |
| 12 | Iron (Fe) | Less than 80 ppm | NMT 80 ppm |
| 13 | Assay (on dried basis) | 99.8% | 99.0%-101.0% |
| 14 | Loss on drying at 150° for 6 Hr | 9.6% | 8.7%-11.4% |
| 15 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 16 | Total Yeast & mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 17 | Bacterial endotoxins | Less than 30 EU/gm | NMT 30 EU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, 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.
