| Isopropyl alcohol excipient grade 20KG | |||
| 81390LK020 | 599861717KU | ||
| Excipient Grade | 5998617 | ||
| 67-63-0 | 79989 | ||
| CH3CH(OH)CH3 | November 2021 | ||
| 60.1 | October 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Transparent, clear, colorless, mobile, volatile liquid, having a characteristic odor & a slightly bitter taste. is flammable .Clear, colourless liquid. | Transparent, clear, colorless, mobile, volatile liquid, having a characteristic odor & a slightly bitter taste. Is flammable ,Clear, colourless liquid. |
| 2 | Solubility | Passes | Miscible with water, with alcohol, with ether & with chloroform and with ethanol (96%) |
| 3 | Identification by Relative density, 20°C | 0.786 | 0.785 to 0.789 |
| 4 | Identification (By Refractive index, 20±0.5°C) | 1.377 | 1.376 to 1.378 |
| 5 | Identification by IR | Complies | To comply the test |
| 6 | Identification by Chemical test | Complies | To comply the test |
| 7 | Identification By GC Chromatogram | Complies | The retention time of the major peak of sample solution corresponds to reference 2-propanol standard. |
| 8 | Specific gravity,25°C | 0.787 | Between 0.783-0.787 |
| 9 | Assay (GC) | 99.94% | Not less than 99.0% |
| 10 | UV absorbance profile (10mm cell) at 230nm | 0.138 | 0.30 max |
| 11 | UV absorbance profile (10mm cell) at 250nm | 0.052 | 0.10 max |
| 12 | UV absorbance profile (10mm cell) at 270nm | 0.011 | 0.03 max |
| 13 | UV absorbance profile (10mm cell) at 290nm | 0.008 | 0.02 max |
| 14 | UV absorbance profile (10mm cell) at 310nm | 0.001 | 0.01 max |
| 15 | Benzene and related substances, (Benzene) | Not detected | 2ppm max |
| 16 | Benzene and related substances, (Total impurity apart from 2-butanol) | 0.037% | 0.3% max |
| 17 | Acidity or Alkalinity | Complies | To Comply the test |
| 18 | Peroxides | Complies | No colour developes |
| 19 | Non-volatile substances | 6ppm | 20ppm max |
| 20 | Water (By KF) | 0.057% | 0.5% max |
| 21 | Limit of volatile impurities (Each individual impurity) | 0.003% | Not more than 0.1% |
| 22 | Limit of volatile impurities (Total impurity) | 0.01% | Not more than 1.0% |
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.
