| 1 | Description | White crystalline solid. | White,or yellowish white crystalline powder, crystalline solid. | USP-NF/Ph.eur |
| 2 | Solubility | Complies | Freely soluble in alcohol, in chloroform, in ether, heptane and in vegetable oils. Insoluble in water & in propylene glycol Very soluble in acetone. | USP-NF/Ph.eur |
| 3 | Identification (by IR) | Complies | IR Spectra of the sample should be concomitant with IR spectra of standard | USP-NF/Ph.eur |
| 4 | Identification by chromatogram | Complies | The retention time of the BHT peak of the sample solution corresponds to that of the standard solution as obtained in the assay. | USP-NF/Ph.eur |
| 5 | Appearance of solution | Complies | The solution is clear and not more intensely coloured than reference solution Y5 or BY5. | Ph.Eur |
| 6 | Assay | 99.92% | 99.0%-101.5% | USP-NF |
| 7 | Residue on ignition /Sulfated ash | 0.001% | NMT 0.002% | USP-NF |
| 8 | Organic impurities : p-Cresol or m- cresol | Not detected | NMT 0.1% | USP-NF |
| 9 | Organic impurities : 3-tert-Butyl-4Hydroxyanisole (BHA) | Not detected | NMT 0.1% | USP-NF |
| 10 | Organic impurities: 3,5-Di-tert-butyl-4-hydroxybenzoic acid | Not detected | NMT 0.1% | USP-NF |
| 11 | Organic impurities : 2-tert-Butyl-4-methylphenol or 2-tert-butyl-5-methylphenol | Not detected | NMT 0.1% | USP-NF |
| 12 | Organic impurities : 3,5-Di-tert-butyl-4-hydroxybenzaldehyde | Not detected | NMT 0.1% | USP-NF |
| 13 | Organic impurities : 4,6-Di-tert-butyl-m-cresol | Not detected | NMT 0.1% | USP-NF |
| 14 | Organic impurities : 2,6-Di-tert-butyl-phenol | Not detected | NMT 0.1% | USP-NF |
| 15 | Organic impurities : Any unspecified impurity | Not detected | NMT 0.1% | USP-NF |
| 16 | Organic impurities : total impurities | Not detected | NMT 0.7% | USP-NF |
| 17 | Assay (Anhydrous basis) | 99.3% | 98.0% to 102.0% | Ph.Eur |
| 18 | Related Substance :Any Unspecified impurity | Not detected | NMT 0.10% | Ph.Eur |
| 19 | Related substances (Total impurity) | Not detected | NMT 0.2% | Ph.Eur |
| 20 | Water | 0.02% | NMT 0.2% | Ph.Eur |
| 21 | Residual Solvents (Methanol) | 0.09% | NMT 0.3% | In-house |