| Isopropyl alcohol CPH8 | |||
| 83390TKL01 | 342569210CU | ||
| Customised pharma grade 8 | 3425692 | ||
| 67-63-0 | 72847 | ||
| CH3CH(OH)CH3 | March 2021 | ||
| 60.1 | February 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Transparent, clear, colorless, mobile, volatile liquid. | Transparent, Clear, colourless, mobile, volatile liquid. |
| 2 | Solubility | Passes | Miscible with water, with alcohol, with ether & with chloroform and with ethanol(96%) |
| 3 | Identification A (By IR) | Complies | The infrared absorption spectrum of the sample exhibits maxima only at the same wave lengths as that of a Isopropyl alcohol reference standard or working standard. |
| 4 | Identification B (By Relative density, 20°C) | 0.786 | Between 0.785 and 0.789 |
| 5 | Identification C (By Chemical test) | Complies | The colour changes to blue. |
| 6 | Identification D (By Chemical test) | Complies | A White or yellowish white precipitate is produced with mercuric sulphate solution. |
| 7 | Identification E (By Chemical test) | Complies | Acetone, recognizable by its odour is evolved with dilute potassium dichromate solution and sulphuric acid. |
| 8 | Identification F (By refractive index, 20°C) | 1.377 | Between 1.377 and 1.378 |
| 9 | Identification G (By GC) | Complies | The retention time of the major peak of the sample solution corresponds to the 2-propanol peak of the system suitability solution, as obtained in the Assay. |
| 10 | Specific gravity, 25°C | 0.784 | Between 0.783 and 0.787 |
| 11 | wt per ml | 0.786g | Between 0.782g and 0.786g |
| 12 | Refractive index,20° C | 1.377 | Between 1.377 and 1.378 |
| 13 | Appearance of solution | Passes | A). The substance to be examined is clear and colourless. B). Sample ( 1 in 20) is clear after 5 minutes. |
| 14 | Limit of volatile impurities (Each individual impurity) | 0.01% | Not more than 0.1% |
| 15 | Limit of volatile impurities (Total impurity) | 0.02% | Not more than 1.0% |
| 16 | Acidity or Alkalinity | 0.3 mL of 0.01 M sodium hydroxide | Not more than 0.6 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator to pale pink. |
| 17 | Absorbance at 230nm | 0.110 | 0.30 max. |
| 18 | Absorbance at 250nm | 0.026 | 0.10 max. |
| 19 | Absorbance at 270nm | 0.003 | 0.03 max. |
| 20 | Absorbance at 290nm | 0.001 | 0.02 max. |
| 21 | Absorbance at 310nm | 0.000 | 0.01 max. |
| 22 | Absorbance (Between 230 nm - 310 nm) | Passes | The spectrum shows a steadily descending curve with no observable peaks or shoulders. |
| 23 | Benzene and related substances, (Benzene) | Not detected | 2 ppm max. |
| 24 | Benzene and related substances, (Total impurity apart from 2-butanol) | 0.02% | 0.3% max. |
| 25 | Peroxides | Passes | No colour develops. |
| 26 | Non-volatile substances | 5 ppm | 20 ppm max. |
| 27 | Water | 0.078% | 0.1% w/w max. |
| 28 | Assay (GC) | 99.98% | Not less than 99.0% |
| 29 | Distillation range | 96.0% distil between 81°C and 83°c | Not less than 95.0% v/v distils between 81°C and 83°C |
| 30 | Aldehydes & ketones | Passes | Not more than 2.0 mL of 0.1 M Sodium hydroxide is required |
| 31 | Water insoluble matter | Passes | No opalescence is produced |
| 32 | Residual solvent (cyclohexane) | Not detected | 0.005% max. |
| 33 | Residual solvent(1-Propanol) | 0.002% | 0.2% max. |
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.
