| Creatinine USP-NF PARENTEX 25KG | |||
| P7504SK025 | 47087A901IY | ||
| USP-NF PARENTEX | 47087A9 | ||
| 60-27-5 | 115066 | ||
| 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 |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP SPECIFICATION.
Actylis 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.
