
| Creatinine CDMF PARENTEX 500G | |||
| P3504SG500 | 47087C301IY | ||
| CDMF PARENTEX | 47087C3 | ||
| 60-27-5 | 115068 | ||
| C4H7N3O | September 2025 | ||
| 113.12 | August 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White crystalline powder, odorless. | White crystals or crystalline powder, odorless | USP-NF |
| 2 | Solubility | Complies | Soluble in water, slightly soluble in alcohol, practically insoluble in acetone, in ether, and in chloroform | USP-NF |
| 3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard | USP-NF |
| 4 | Assay (on dry basis) | 99.5% | 98.5%-102.0% | USP-NF |
| 5 | Residue on ignition | 0.03% | NMT 0.2% | USP-NF |
| 6 | Loss on drying (105°C, 3 Hrs) | 0.4% | NMT 3.0% | USP-NF |
| 7 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 8 | Total Yeast & mold count | Less than 10 CFU/gm | NMT 10 CFU/gm | In-house |
| 9 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm | In-house |
| Tested By (Chemist - Quality Control) | Approved By (Head - Quality Control) |