1 | Description | Clear, viscous, colorless, hygroscopic, oily liquid. | Clear, viscous, colorless or almost colorless, hygroscopic, oily liquid’. |
2 | Appearance of solution | Passes | The substance to be examined is clear and not more intensely colored than reference solution BY6’ |
3 | Solubility | Passes | Slightly soluble in water, miscible with alcohol, ethanol (96%), slightly soluble in fatty oils. |
4 | Identification (By Refractive index, 20±0.5°C) | 1.442 | 1.440 -1.446 |
5 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. |
6 | Identification (By GC Chromatogram) | Complies | The retention time of the major peak of the sample solution corresponds to that of a similar preparation of triethyl citrate standard as obtained in the assay. |
7 | Identification (Reaction of esters) | Complies | A bluish-red or red color should produce. |
8 | Identification (Reaction of citrates) | Complies | Violet color turning to violet-blue should produce. |
9 | Assay (By GC) On anhydrous basis | 99.99% | 99.0% -100.5% |
10 | Acidity | Passes | Not more than 0.5mL of 0.1 mol/L sodium hydroxide should require to produce blue color. |
11 | Specific gravity, 25°C | 1.137 | 1.135-1.139 |
12 | Refractive index, 25°C | 1.440 | 1.439-1.441 |
13 | Refractive index (20°C ± 0.5°C) | 1.442 | 1.440 to 1.446 |
14 | Related substances (Any impurity) | 0.02% | 0.2% max |
15 | Related substances (Total impurity) | 0.03% | 0.5% max |
16 | Water | 0.029% | 0.25% max |
17 | Sulfated ash | 0.039% | 0.1% max |