| Butylated hydroxytoluene Excipient Grade 1KG | |||
| 80380SR100 | 513701729FO | ||
| Excipient Grade | 5137017 | ||
| 128-37-0 | 18802 | ||
| C15H24O | June 2015 | ||
| 220.35 | May 2018 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | A White, crystalline powder having faint characteristic odour. | A white or yellowish-white, crystalline powder having faint characteristic odour. |
| 2 | Solubility | Passes | Very soluble in acetone, in chloroform and in ether, freely soluble in ethanol (95%), alcohol, in chloroform, in methanol, in fixed oils and in fats; Insoluble in water & in propylene glycol. |
| 3 | Identification A (by Freezing point) | Complies | To comply the test |
| 4 | Identification A (By IR) | Complies | To Comply the test (USP) |
| 5 | Identification B (by UV absorbance test) | Complies | To comply the test |
| 6 | Identification C (By IR) | Complies | To comply the test |
| 7 | Identification D (By chemical test) | Complies | To comply the test |
| 8 | Appearance of Solution | Complies | The solution is clear and not more intensely coloured than reference solution Y5 or BY5. |
| 9 | Freezing point | 69°-70°C | 69.0°C - 70°C |
| 10 | Congealing temperature | 69.4°C | Not less than 69.2°C |
| 11 | Related substances (by TLC) | Complies | Any spot in the chromatogram obtained with the test solution, apart from in principal spot, is not more intense than the spot in the chromatogram obtained with the reference solution. (0.5% max) |
| 12 | Organic impurities | Complies | Any spot from the sample solution apart from the principal spot, is not more intense than the spot from the standard solution (NMT 0.5%) |
| 13 | Residue on ignition | 0.00075% | NMT 0.002% |
| 14 | Heavy metals | Not Detected | 10ppm max |
| 15 | Assay (GC) | 99.94% | Not less than 99.0% |
| 16 | Methanol as residual solvent | NMT 0.3% | 0.3% max |
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.
