| Creatinine USP-NF PARENTEX 5KG | |||
| P7504SR500 | 47410A906JY | ||
| USP-NF PARENTEX | 47410A9 | ||
| 60-27-5 | 116230 | ||
| C4H7N3O | October 2025 | ||
| 113.12 | September 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White crystals, 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) | 99.07% | 98.5%-102.0% | USP-NF |
| 5 | Residue on ignition | 0.07% | NMT 0.2% | USP-NF |
| 6 | Loss on drying (105°C, 3 Hrs) | 0.52% | 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-NF 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.
