| Isopropyl alcohol CPH8 160KG | |||
| 83390LK160 | 325219231GT | ||
| Customised pharma grade 8 | 3252192 | ||
| 67-63-0 | 66352 | ||
| CH3CH(OH)CH3 | July 2020 | ||
| 60.1 | June 2023 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Transparent, clear, colorless, mobile, volatile liquid. | Transparent, clear, colorless, mobile, volatile liquid. |
| 2 | Solubility | Passes | Miscible with water, with alcohol, with ether & with chloroform and with ethanol (96%) |
| 3 | Identification (Relative density, 20°C) | 0.786 | 0.785 to 0.789 |
| 4 | Identification (By Refractive index, 20±0.5°C) | 1.378 | 1.377 to 1.378 |
| 5 | Identification by IR | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard |
| 6 | Identification by Chemical test | Complies | The entire sulfuric acid layer should turn violet. |
| 7 | Identification (By GC Chromatogram) | Complies | The retention time of the major peak of sample solution corresponds to reference 2-propanol standard. |
| 8 | Distillation range | 81°-83°C | 81°-83°C, not less than 94% vol % |
| 9 | Specific gravity, 25°C | 0.785 | Between 0.783-0.787 |
| 10 | Specific gravity, 20°C | 0.786 | Between 0.785-0.788 |
| 11 | Assay (GC) | 99.97% | Not less than 99.0% |
| 12 | UV absorbance profile (10mm cell) @ 230nm | 0.206 | 0.30 max |
| 13 | UV absorbance profile (10mm cell)@250nm | 0.078 | 0.10 max |
| 14 | UV absorbance profile (10mm cell) at 270nm | 0.007 | 0.03 max |
| 15 | UV absorbance profile (10mm cell) at 290nm | 0.004 | 0.02 max |
| 16 | UV absorbance profile (10mm cell) at 310nm | 0.000 | 0.01 max |
| 17 | Benzene and related substances, (Benzene) | Not detected | 2ppm max |
| 18 | Benzene and related substances, (Total impurity apart from 2-butanol) | 0.03% | 0.3% max |
| 19 | Acidity or Alkalinity | Passes | Not more than 0.6 mL of 0.01 M sodium hydroxide should require to change the colour of the indicator to pale pink. |
| 20 | Peroxides | Passes | No colour should develop |
| 21 | Non-volatile substances | 3ppm | 20ppm max |
| 22 | Water (By KF) | 0.05% | 0.5% max |
| 23 | Limit of volatile impurities (Each individual impurity) | 0.022% | Not more than 0.1% |
| 24 | Limit of volatile impurities (Total impurity) | 0.03% | Not more than 1.0% |
| 25 | Clarity of solution | Passes | Clear solution |
| 26 | Appearance of solution | Passes | Solution of 1mL sample in 20 mL of water should be clear and colourless |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur, BP, JP 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.
