| Disodium Edetate USP/Ph.Eur PARENTEX PLUS 5KG | |||
| I0660SR500 | 43121B615CX | ||
| USP/Ph.Eur PARENTEX PLUS | 43121B6 | ||
| 6381-92-6 | 102105 | ||
| C10H14N2Na2O8.2H2O | March 2024 | ||
| 372.24 | February 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | 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 spectra of standard |
| 4 | Identification B (By Chemical test 1) | Complies | No yellow precipitate should form. |
| 5 | Identification B (By Chemical test 2) | Complies | No precipitate should form. |
| 6 | Identification B (By Chemical test 3) | Complies | The red color should discharge, leaving a yellowish solution. |
| 7 | Identification C (By Chemical test) | Complies | No precipitate should form. |
| 8 | Identification (Sodium) | Complies | A dense white precipitate should form. |
| 9 | Appearance of Solution | Complies | Solution should be clear and colorless. |
| 10 | pH | 4.4 | 4.0-5.5 |
| 11 | Impurity A (Nitrilotriacetic acid) | 0.02% | NMT 0.1% |
| 12 | Calcium (Ca) | Complies | No precipitate should form. |
| 13 | Iron (Fe) | Less than 80ppm | NMT 80ppm |
| 14 | Assay (on dried basis) | 99.8% | 99.0% - 101.0% |
| 15 | Loss on drying at 150° for 6 Hr | 9.8% | 8.7%-11.4% |
| 16 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 17 | Total Yeast & mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 18 | Escherichia coli | Absent/gm | should be absent/gm |
| 19 | Pseud. aeruginosa | Absent/gm | should be absent/gm |
| 20 | Staphylococcus aureus | Absent/gm | should be absent/gm |
| 21 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
| 22 | Salmonella | Absent/10 gm | should be absent/10 gm |
| 23 | 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.
