| Acetone Excipient Grade 25LT | |||
| 80020LL025 | 603531715BV | ||
| Excipient Grade | 6035317 | ||
| 67-64-1 | 82426 | ||
| CH3COCH3 | February 2022 | ||
| 58.08 | January 2025 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Transparent, colorless, mobile, volatile liquid, having a characteristic odor. A solution (1 in 2) is neutral to litmus. | Transparent, colorless, mobile, volatile liquid, having a characteristic odor. A solution (1 in 2) is neutral to litmus. |
| 2 | Solubility | Passes | Miscible with water, with alcohol, with ether, with chloroform, and with most volatile oils. |
| 3 | Appearance of solution | Passes | Clear and colorless solution |
| 4 | Identification (By IR) | Complies | IR Spectra of the sample should be concomitant with IR spectra of the standard |
| 5 | Identification (by Chromatogram) | Complies | The retention time of the sample corresponds to that of standard obtained in the assay |
| 6 | Identification (Relative density, 20°C) | 0.791 | 0.790 - 0.793 |
| 7 | Identification (By chemical test 1) | Complies | An intense red color should produce which becomes violet with the addition of 3.5 mL of acetic acid |
| 8 | Identification (By chemical test 2) | Complies | A greenish-blue color should produce |
| 9 | Relative density, 20°C | 0.791 | 0.790 to 0.793 |
| 10 | Assay (GC) | 99.98% | NLT 99.0% on the anhydrous basis. |
| 11 | Specific gravity,25°C | 0.789 | NMT 0.789 |
| 12 | Non-volatile Residue | 0.002% | 0.004% max |
| 13 | Matter insoluble in water | Passes | The solution should be clear |
| 14 | Water | 2.3g/l | 3g/l max |
| 15 | Reducing substances | Passes | The mixture should not be completely decolorised |
| 16 | Acidity or Alkalinity | Passes | The solution should be red or orange |
| 17 | Related substances: Impurity A (Methanol) | 0.02% | 0.05% v/v max |
| 18 | Related substances: Impurity B (2-Propanol) | Not detected | 0.05% v/v max |
| 19 | Related substances: Impurity C (Benzene) | Not detected | 2 ppm v/v max |
| 20 | Related substances: Any other impurity | 0.003% | 0.05% v/v max |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, 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.
