| Disodium Edetate CDMF PARENTEX PLUS 5KG | |||
| I3660SR500 | 40136B418BW | ||
| CDMF PARENTEX PLUS | 40136B4 | ||
| 6381-92-6 | 92663 | ||
| C10H14N2Na2O8.2H2O | February 2023 | ||
| 372.24 | January 2026 | ||
| 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 (By chemical test 1) | Complies | No precipitate should formed. |
| 5 | Identification (By chemical test 2) | Complies | No precipitate should formed. |
| 6 | Identification (By chemical test 3) | Complies | The red color should discharged, leaving a yellowish solution. |
| 7 | Identification (By chemical test 4) | Complies | A dense white precipitate should formed. |
| 8 | Appearance of Solution / Clarity and color of solution | Complies | Solution should be clear and colorless. |
| 9 | pH / Acidity | 4.63 | 4.0 – 5.0 |
| 10 | Impurity A (Nitrilotriacetic acid) | Not detected | NMT 0.1% |
| 11 | Calcium (Ca) | Complies | No precipitate should formed. |
| 12 | Assay (on dried basis) | 99.7% | 99.0% – 101.0% |
| 13 | Loss on drying at 150° for 6 Hr | 9.7% | 8.7% – 11.4% |
| 14 | Chelating capacity test | Complies | Test solution with Solution 1 should be clear. Test solution with Solution 2 should be light blue and should not be any red. |
| 15 | Chlorides | Less than 0.004% | NMT 0.004% |
| 16 | Iron | Less than 0.002% | NMT 0.002% |
| 17 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 18 | Total Yeast & mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 19 | Escherichia coli | Absent/gm | should be Absent/gm |
| 20 | Pseud. aeruginosa | Absent/gm | should be Absent/gm |
| 21 | Staphylococcus aureus | Absent/gm | should be Absent/gm |
| 22 | Bile-tolerant gram negative bacteria | Absent/gm | should be Absent/gm |
| 23 | Salmonella | Absent/10gm | should be Absent/10gm |
| 24 | 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.
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.
