1 | Appearance | Clear, transparent, colorless volatile liquid having a fragrant, 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 | 99.65% | 98.0% - 102.0% |
9 | Chromatographic purity (Acetaldehyde) | 0.02% | NMT 0.1% |
10 | Chromatographic purity (1-Ethoxy-2-methylpropane) | Not detected | NMT 0.1% |
11 | Chromatographic purity (Methyl compounds) | 0.03% | NMT 0.1% |
12 | Chromatographic purity (Other impurities) | 0.09% | NMT 0.3% |
13 | Acidity | Complies | The solution should remain pink for not less than 15 s. |
14 | Specific gravity (25°C) | 0.895 | 0.894-0.898 |
15 | Relative density (20°C) | 0.899 | 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) | 0.03% | Not more than 0.2 per cent of the area of the principal peak. |
20 | Residue on evaporation | 8ppm | NMT 30 ppm |
21 | Limit of Non-volatile residue | 0.0008% | NMT 0.02% |
22 | Water (By KF) | 0.036% | 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 |