| Triethyl citrate USP-NF/Ph.Eur 2LT | |||
| 97873LC200 | 43210H623CX | ||
| USP-NF/Ph.Eur | 43210H6 | ||
| 77-93-0 | 102462 | ||
| C12H20O7 | March 2024 | ||
| 276.29 | February 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Clear, viscous, practically colourless, hygroscopic, oily liquid | Clear, viscous, practically colourless or almost colourless, hygroscopic, oily liquid. |
| 2 | Solubility | Complies | Soluble in water, miscible with alcohol, ethanol (96%) and ether, slightly soluble in fatty oils. |
| 3 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. |
| 4 | Identification (By Refractive index, 20±0.5°C) | 1.442 | 1.440 -1.446 |
| 5 | 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. |
| 6 | Identification (Reaction of esters) | Complies | A bluish-red or red color should produce. |
| 7 | Identification (Reaction of citrates) | Complies | Violet color turning to violet-blue should produce. |
| 8 | Appearance of solution | Complies | The substance to be examined is clear and not more intensely colored than reference solution BY6. |
| 9 | Assay (By GC) On anhydrous basis | 100.2% | 97.0% -102.0% |
| 10 | Assay (By Titration) | 99.8% | 98.5%-101.0% (anhydrous substance) |
| 11 | Acidity | Complies | Not more than 0.3mL of 0.1 N sodium hydroxide should require to change the colour of the indicator to blue. |
| 12 | Specific gravity, 25°C | 1.137 | 1.135-1.139 |
| 13 | Refractive index, 25°C | 1.440 | 1.439-1.441 |
| 14 | Refractive index (20°C ± 0.5°C) | 1.442 | 1.440 to 1.446 |
| 15 | Related substances (Any impurity) | 0.07% | NMT 0.2% |
| 16 | Related substances (Total impurity) | 0.1% | NMT 0.5% |
| 17 | Water | 0.20% | NMT 0.25% |
| 18 | Sulfated ash | 0.009% | NMT 0.1% |
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP-NF 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.
