| 2-Pyrrolidone Ph.Eur/BP PARENTEX 1LT | |||
| P6079LC100 | 40946J327EW | ||
| Ph.Eur/BP PARENTEX | 40946J3 | ||
| 616-45-5 | 95793 | ||
| C4H7NO | May 2023 | ||
| 85.1 | April 2025 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Clear, colorless liquid. | Clear, colorless or slightly greyish liquid, or white to almost white crystals, or colorless crystals needles. |
| 2 | Solubility | Complies | Miscible with water, with ethanol (96%) and with most common organic solvent. |
| 3 | Melting point | 24.9°C | about 25°C |
| 4 | Boiling point | 245°C | about 245°C |
| 5 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
| 6 | Relative density | 1.113 | 1.112 - 1.115 |
| 7 | Refractive index, 20°C | 1.488 | 1.487 - 1.490 |
| 8 | Appearance of solution | Complies | The sample to be examined should clear and should not more intensely colored than intensity 7 of the range of reference solutions of all most appropriate colour. |
| 9 | Alkalinity | Complies | NMT 8.0ml of 0.02M Hydrochloric acid required. |
| 10 | Related substances,Impurity A | 0.031% | NMT 0.15% |
| 11 | Related substances,Impurity B | Not detected | NMT 0.5% |
| 12 | Related substances,Impurity C | Not detected | NMT 0.15% |
| 13 | Related substances, unspecified impurities | 0.07% | NMT 0.10% |
| 14 | Related substances, total impurities | 0.2% | NMT 0.7% |
| 15 | Water (by coulometric) | 0.015% | NMT 0.1% |
| 16 | Sulphated ash | 0.03% | NMT 0.1% |
| 17 | Total aerobic microbial count | Less than 100 CFU/ml | NMT 100 CFU/ml |
| 18 | Total Yeast and mold count | Less than 10 CFU/ml | NMT 10 CFU/ml |
| 19 | Bacterial endotoxin test | 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 Ph.Eur , BP 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.
