| Acetone Excipient Grade 200LT | |||
| 80020LL200 | 598211705JU | ||
| Excipient Grade | 5982117 | ||
| 67-64-1 | 78939 | ||
| CH3COCH3 | October 2021 | ||
| 58.08 | September 2024 | ||
| 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) | 0.790 | 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 | 0.790 | 0.790 to 0.793 |
| 10 | Assay (GC) | 99.97% | NLT 99.0% on the anhydrous basis. |
| 11 | Specific gravity,25°C | 0.789 | NMT 0.789 |
| 12 | Non-volatile Residue | 0.0008% | 0.004% max |
| 13 | Matter insoluble in water | Passes | The solution should be clear |
| 14 | Water | 1.9g/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 | 0.01% | 0.05% v/v max |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, 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.
