| Ethyl acetate USP-NF/Ph.Eur 200LT | |||
| 97680LL200 | 175307128CP | ||
| USP/Ph.Eur | 1753071 | ||
| 141-78-6 | 27605 | ||
| CH3COOC2H5 | March 2016 | ||
| 88.1 | February 2019 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Clear,trasparent,colourless volatile liquid having a fragrant ,refreshing,slightly acetous odor and a peculiar, acetous,buring taste | Clear, trasparent, colourless volatile liquid having a fragrant, refreshing, slightly acetous odor and a peculiar, acetous, buring taste. |
| 2 | Solubility | Passes | Soluble in water, with ether, fixed oils and with volatile oils; miscible with acetone, with alcohol (96 per cent) and with methylene chloride. (USP/Ph.Eur) |
| 3 | Identification A (By Boiling point) | 77°C | 76° - 78°C (Ph.Eur) |
| 4 | Identification A | Passes | Passes test (USP) |
| 5 | Identification B (By IR) | Complies | To comply the test (Ph.Eur) |
| 6 | Identification C (By Chemical test) | Complies | To give reaction of acetyl (Ph.Eur) |
| 7 | Identification D (By Chemical test) | Complies | To give reaction of esters (Ph.Eur) |
| 8 | Appearance of solution | Passes | The solution is clear and colourless (Ph.Eur) |
| 9 | Acidity | Passes | Passes test (USP/Ph.Eur) |
| 10 | Relative density (20°C) | 0.898 | 0.898 - 0.902 (Ph.Eur) |
| 11 | Specific gravity (25°C) | 0.894 | 0.894 - 0.898 (USP) |
| 12 | Refractive index (20°C ± 0.5°C) | 1.370 | 1.370 - 1.373 (Ph.Eur) |
| 13 | Related substances (Total impurity) | 0.02% | The sum of the areas of any peaks apart from the principal peak is not greater than 0.2% of the area of the principal peak. (Ph.Eur) |
| 14 | Residue on evaporation | 2 ppm | 30 ppm max (Ph.Eur/USP) |
| 15 | Methyl compounds | Passes | No violet color appears. (USP) |
| 16 | Readily carbonizable substances | Passes | No dark zone is developed with in 15 min. (USP/ Ph.Eur) |
| 17 | Reaction with sulphuric acid | Complies | To Comply the test (Ph.Eur) |
| 18 | Water (By KF) | 0.019% | 0.1% max (Ph.Eur) |
| 19 | Assay (By Titration) | 99.98% | 99.0% - 100.5% (USP) |
| 20 | Chromatographic purity by GC | 99.98% | THe area of the ethyl acetate peak is NLT 99.5% of the sum of the area of all peaks. (USP) |
| 21 | Residual solvent (ICH) | Complies | To comply the test |
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP 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.
