| Acetone USP-NF/Ph.Eur/BP PARENTEX PLUS 25L | |||
| I0020LL025 | 47958C108AZ | ||
| USP-NF/Ph.Eur/BP PARENTEX PLUS | 47958C1 | ||
| 67-64-1 | 117859 | ||
| CH3COCH3 | January 2026 | ||
| 58.08 | December 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | Transparent,clear, colorless, mobile, volatile liquid, having a characteristic odor. A solution (1 in 2 ) is neutral to litmus. | Transparent,clear, colorless, mobile, volatile liquid, having a characteristic odor. A solution (1 in 2) is neutral to litmus. | USP-NF/Ph.Eur/BP |
| 2 | Solubility | Complies | Miscible with water, with alcohol (ethanol 96%), with ether, with chloroform, and with most volatile oils. | USP-NF/Ph.Eur/BP |
| 3 | Appearance of solution | Complies | Clear and colourless solution | Ph.Eur/BP |
| 4 | Identification (by IR) | Complies | IR Spectra of the sample should be concomitant with IR spectra of the standard | USP-NF |
| 5 | Identification (by Chromatogram) | Complies | The retention time of the sample corresponds to that of standard obtained in the assay | USP-NF |
| 6 | Identification (Relative density, 20°C) | 0.791 | 0.790 - 0.793 | Ph.Eur/BP |
| 7 | Identification (By chemical test 1) | Complies | An intense red color should produce which becomes violet with the addtion of 3.5 mL of acetic acid | Ph.Eur/BP |
| 8 | Identification (By chemical test 2) | Complies | A grenish-blue color should produce | Ph.Eur/BP |
| 9 | Relative density, 20°C | 0.791 | 0.790 to 0.793 | Ph.Eur/BP |
| 10 | Assay (GC) | 99.98% | NLT 99.0% on the anhydrous basis. | USP-NF |
| 11 | Specific gravity,25°C | 0.788 | NMT 0.789 | USP-NF |
| 12 | Non-volatile Residue | 0.001% | The weight of the residue does not exceed 2 mg (NMT 0.004%) | USP-NF |
| 13 | Matter insoluble in water | Complies | The solution should be clear | Ph.Eur/BP |
| 14 | Water | 2g/l | NMT 3g/l | Ph.Eur/BP |
| 15 | Reducing substances | Complies | The mixture should not be completely decolorised | Ph.Eur/BP |
| 16 | Acidity or Alkalinity | Complies | The solution should be red or orange | Ph.Eur/BP |
| 17 | Related substances: Impurity A (Methanol) | 0.03% | NMT 0.05% v/v | Ph.Eur/BP |
| 18 | Related substances: Impurity B (2-Propanol) | Not detected | NMT 0.05% v/v | Ph.Eur/BP |
| 19 | Related substances: Impurity C (Benzene) | Not detected | NMT 2 ppm v/v | Ph.Eur/BP |
| 20 | Related substances: Any other impurity | 0.002% | NMT 0.05% v/v | Ph.Eur/BP |
| 21 | Total aerobic microbial count | Less than 100 CFU/ml | NMT 100 CFU/ml | In-house |
| 22 | Total combined yeast and mould count | Less than 10 CFU/ml | NMT 10 CFU/ml | In-house |
| 23 | E.coli | Absent/ml | Should be absent/ml | In-house |
| 24 | Staphylococcus aureus | Absent/ml | Should be absent/ml | In-house |
| 25 | Pseud. aeruginosa | Absent/ml | Should be absent/ml | In-house |
| 26 | Salmonella | Absent/10ml | Should be absent/10ml | In-house |
| 27 | Bacterial endotoxins | Less than 2 EU/ml | NMT 2 EU/ml | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, Ph.Eur , BP SPECIFICATION.
Actylis 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.
