| Methylpyrrolidone USP-NF/Ph.Eur PARENTEX 35LT | |||
| P0970LL035 | 36835G123AV | ||
| USP-NF/Ph.Eur PARENTEX | 36835G1 | ||
| 872-50-4 | 82073 | ||
| C5H9NO | January 2022 | ||
| 99.13 | December 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | A clear colourless liquid. | A clear colourless to very slightly yellow liquid. |
| 2 | Solubility | Passes | 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 | 1.034 | 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 | 0.12% | NMT 0.3% |
| 9 | Alkalinity | 5.8ml of 0.02M hydrochloric acid | NMT 8.0ml of 0.02M hydrochloric acid is required. |
| 10 | Clarity of solution | Passes | 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 | Passes | The sample should not more intensely colored than the comparison solution |
| 12 | Water (By KF) | 0.02% | 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 AND 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.
