| 1 | Description | White crystalline powder. | 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. The chromatographic profile of the Sample solution should exhibit only one major peak corresponding to the main compound | USP-NF |
| 5 | Appearance of solution | Complies | The solution is clear and not more intensely coloured than reference solution Y5 or BY5. | Ph.Eur |
| 6 | Assay | 100.4% | 99.0%-101.5% | USP-NF |
| 7 | Residue on ignition | 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) | 99.2% | 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 | 0.03% | NMT 0.2% | Ph.Eur |
| 21 | Mesh size | 94.24% passes through 60 mesh | NLT 90% pass through 60 mesh | In-house |
| 22 | Residual Solvents (Methanol) | 0.011% | NMT 0.3% | In-house |
| 23 | Sulphated ash | 0.03% | NMT 0.1% | Ph.Eur |