| Pentetic acid CDMF PARENTEX 500GM | |||
| P3577SG500 | 43249C302DX | ||
| CDMF PARENTEX | 43249C3 | ||
| 67-43-6 | 102461 | ||
| C14H23N3O10 | April 2024 | ||
| 393.35 | March 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White odorless powder, Melts with foaming and degradation at 219.9°C | White odorless or almost odorless powder. Melts with foaming and degradation at 220°C. |
| 2 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
| 3 | Residue on ignition | 0.06% | NMT 0.2% |
| 4 | Limit of Nitrilotriacetic acid | Not detected | NMT 0.1% |
| 5 | Iron (Fe) | Less than 0.01% | NMT 0.01% |
| 6 | Assay | 98.9% | 98.0% - 100.5% |
| 7 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 8 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 9 | Bacterial endotoxin test | Less than 5 EU/gm | NMT 5 EU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP 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.
