| Isopropyl alcohol Excipient Grade 2.5LT | |||
| 81390LC250 | 532931714DP | ||
| Excipient Grade | 5329317 | ||
| 67-63-0 | 27845 | ||
| CH3CH(OH)CH3 | April 2016 | ||
| 60.1 | March 2019 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | Clear, colourless, transparent, mobile, volatile liquid, having a characteristic odor & a slightly bitter taste. Is flammable. | Clear, colourless, transparent, mobile, volatile liquid, having a characteristic odor & a slightly bitter taste. Is flammable. |
| 2 | Solubility | Passes | Miscible with water and with alcohol with ether & with chloroform. |
| 3 | Identification by IR | Complies | To comply the test |
| 4 | Identification By GC Chromatogram | Complies | The retention time of the major peak of sample solution corresponds to reference 2-propanol standard. |
| 5 | Identification by Chemical test | Complies | To comply the test |
| 6 | Relative density,20°C | 0.785 | 0.785 - 0.789 |
| 7 | Refractive index, 20°C ± 0.5°C | 1.377 | 1.376 - 1.378 |
| 8 | Distillation range(95%) | 81°-83°C | 81° - 83°C |
| 9 | Specific gravity, 25°C | 0.784 | 0.783 - 0.787 |
| 10 | Appearance of solution | Complies | Clear & colourless solution. |
| 11 | UV absorbance profile (10mm cell) at 230 nm | 0.106 | 0.30 max. |
| 12 | UV absorbance profile (10mm cell) at 250 nm | 0.019 | 0.10 max |
| 13 | UV absorbance profile (10mm cell) at 270 nm | 0.004 | 0.03 max. |
| 14 | UV absorbance profile (10mm cell) at 290 nm | 0.003 | 0.02 max. |
| 15 | UV absorbance profile (10mm cell) at 310 nm | 0.003 | 0.01 max. |
| 16 | Non-volatile substance | 5 ppm | 20 ppm max. |
| 17 | Acidity or Alkalinity | Passes test | Passes test |
| 18 | Acidity | Passes | NMT 0.7ml of 0.020 N sodium hydroxide is required for neutralization. |
| 19 | Benzene and related substances,(a)Benzene | NMT 2 ppm | 2 ppm max. |
| 20 | Benzene and related substances,(b)Total impurity apart from 2-butanol | NMT 0.30% | 0.30% max. |
| 21 | Limit of volatile impurities (Each individual impurity) | Not more than 0.1% | Not more than 0.1% |
| 22 | Limit of volatile impurities (Total impurity) | Not more than 1.0% | Not more than 1.0% |
| 23 | Peroxides | Complies | No colour develops |
| 24 | Water | 0.068% | 0.10% max. |
| 25 | Assay (GC) | 99.96% | Min. 99.00% |
| 26 | Residual solvent (ICH) | Complies | To comply the test |
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.
