| Isopropyl alcohol excipient grade 25LT | |||
| 81390LL025 | 630521712AX | ||
| Excipient Grade | 6305217 | ||
| 67-63-0 | 100428 | ||
| CH3CH(OH)CH3 | January 2024 | ||
| 60.1 | December 2026 | ||
| 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 | Complies | 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) | 1.378 | 1.376 to 1.378 |
| 5 | Identification by IR | Complies | IR spectra of the sample should be concomitant with IR spectra of the 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 the 2-propanol peak of the system suitability standard solution, as obtained in the assay. |
| 8 | Identification (Limit of Methanol) | Not detected | NMT 0.02% |
| 9 | Assay (GC) | 99.92% | NLT 99.0% |
| 10 | UV absorbance profile (10mm cell) at 230nm | 0.097 | NMT 0.30 |
| 11 | UV absorbance profile (10mm cell) at 250nm | 0.021 | NMT 0.10 |
| 12 | UV absorbance profile (10mm cell) at 270nm | 0.010 | NMT 0.03 |
| 13 | UV absorbance profile (10mm cell) at 290nm | 0.003 | NMT 0.02 |
| 14 | UV absorbance profile (10mm cell) at 310nm | 0.001 | NMT 0.01 |
| 15 | Absorbance (Between 230 nm - 310 nm) | Complies | The spectrum shows a steadily descending curve with no observable peaks or shoulders. |
| 16 | Benzene and related substances, (Benzene) | Not detected | NMT 2ppm |
| 17 | Benzene and related substances, (Total impurity apart from 2-butanol) | 0.02% | NMT 0.3% |
| 18 | Limit of Volatile Impurities (Methanol) | Not detected | NMT 0.02% |
| 19 | Limit of Volatile impurities (Individual Known impurity ethyl ether) | Not detected | NMT 0.1% |
| 20 | Limit of Volatile impurities (Individual Known impurity acetone) | Not detected | NMT 0.1% |
| 21 | Limit of Volatile impurities (Individual Known impurity diisopropyl ether) | Not detected | NMT 0.1% |
| 22 | Limit of Volatile impurities (Individual Known impurity 1-propanol) | 0.05% | NMT 0.1% |
| 23 | Limit of Volatile impurities (Individual Known impurity 2-butanol) | Not detected | NMT 0.1% |
| 24 | Limit of Volatile impurities (Individual unspecified impurity) | 0.02% | NMT 0.1% |
| 25 | Limit of volatile impurities (Total impurity) | 0.08% | NMT 1.0% |
| 26 | Limit of Non-volatile residue | 5ppm | NMT 20ppm |
| 27 | Specific gravity,25°C | 0.784 | Between 0.783 - 0.787 |
| 28 | Refractive index,20° C | 1.378 | Between 1.376-1.378 |
| 29 | Acidity or Alkalinity | Complies | NMT 0.6ml of 0.01 M sodium hydroxide is required to change the colour of the indicator to pale pink. |
| 30 | Water (By KF) | 0.036% | NMT 0.5% |
| 31 | Peroxides | Complies | No colour developes |
| 32 | Appearance of Solution | Complies | Solution of 1 ml sample in 20ml of water should be clear and colorless. |
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.
