| Ethyl acetate USP-NF/Ph.Eur PARENTEX 2LT | |||
| P0680LC200 | 43115G112CX | ||
| USP-NF/Ph.Eur PARENTEX | 43115G1 | ||
| 141-78-6 | 102091 | ||
| CH3COOC2H5 | March 2024 | ||
| 88.1 | February 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | Clear, transparent, colorless volatile liquid having a frangrant, refreshing, slightly acetous odor. | Clear, transparent, colorless volatile liquid having a fragrant, refreshing, slightly acetous odor. |
| 2 | Solubility | Complies | Soluble in water. Miscible with ether,with fixed oils,with acetone, with volatile oils, with alcohol(96 per cent), with methanol and with methylene chloride. |
| 3 | Identification A (By Boiling point) | 77°C | 76° - 78°C |
| 4 | Identification B (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. |
| 5 | Identification C (Reaction of Acetyl) | Complies | A blue color should develop at the junction of the two drops; the color intensifies and persists for a short time. |
| 6 | Identification D (Reaction of esters) | Complies | A bluish-red or red color should produce. |
| 7 | Appearance of Solution | Complies | The solution is clear and colourless |
| 8 | Assay | 99.16% | 98.0% - 102.0% |
| 9 | Chromatographic purity (Acetaldehyde) | Not detected | NMT 0.1% |
| 10 | Chromatographic purity (1-Ethoxy-2-methylpropane) | Not detected | NMT 0.1% |
| 11 | Chromatographic purity (Methyl compounds) | Not detected | NMT 0.1% |
| 12 | Chromatographic purity (Other impurities) | 0.03% | NMT 0.3% |
| 13 | Acidity | Complies | The solution should remain pink for not less than 15 s. |
| 14 | Specific gravity (25°C) | 0.898 | 0.894-0.898 |
| 15 | Relative density (20°C) | 0.900 | 0.898 - 0.902 |
| 16 | Refractive index (20°C ± 0.5°C) | 1.372 | 1.370 - 1.373 |
| 17 | Reaction with sulphuric acid | Complies | The interface between the 2 liquids should not be colored. |
| 18 | Readily carbonisable substances | Complies | No dark zone is developed within 15 min. |
| 19 | Related substances (Total impurity) | Complies | Not more than 0.2 per cent of the area of the principal peak. |
| 20 | Residue on evaporation | Less than 30 ppm | NMT 30 ppm |
| 21 | Limit of Non-volatile residue | 0.0008% | NMT 0.02% |
| 22 | Water (By KF) | 0.01% | NMT 0.1% |
| 23 | Bacterial endotoxins | Less than 0.05 IU/mg | 0.05 IU/mg |
| 24 | Total aerobic microbial count | Less than 10 CFU/ml | NMT 10 CFU/ml |
| 25 | Total Yeast and mold count | Less than 10 CFU/ml | NMT 10 CFU/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.
