| Methylpyrrolidone USP-NF/PH.EUR PARENTEX 1LT | |||
| P0970LC100 | 42704G104AX | ||
| USP-NF/Ph.Eur PARENTEX | 42704G1 | ||
| 872-50-4 | 100395 | ||
| C5H9NO | January 2024 | ||
| 99.13 | December 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | A clear colourless to very slightly yellow liquid. | A clear colourless to very slightly yellow liquid. |
| 2 | Solubility | Complies | Miscible with water and with most organic solvents including alcohol, ketones and aromatic and chlorinated hydrocarbons |
| 3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. |
| 4 | Boiling point | 205°C | About 204°C |
| 5 | Relative density | 1.035 | about 1.034 |
| 6 | Refractive index | 1.470 | about 1.469 |
| 7 | Organic impurities : individual impurity | 0.04% | NMT 0.1% |
| 8 | Organic impurities : Total impurities | 0.09% | NMT 0.3% |
| 9 | Alkalinity | Complies | NMT 8.0ml of 0.02M hydrochloric acid is required. |
| 10 | Clarity of solution | Complies | The sample should show the same clarity as that of water, or its opalescence is not more pronounced than that of reference suspension |
| 11 | Colour of solution | Complies | The sample should not more intensely colored than the comparison solution |
| 12 | Water (By KF) | 0.06% | NMT 0.1% |
| 13 | Total aerobic microbial count | Less than 100 CFU/mL | NMT 100 CFU/mL |
| 14 | Total Yeast and mold count | Less than 10 CFU/mL | NMT 10 CFU/mL |
| 15 | Bacterial endotoxins | Less than 2.5 EU/mL | NMT 2.5 EU/mL |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, Ph.Eur 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.
