1 | Description | White, crystalline solid, having a faint, characteristic odor. | White, crystalline solid, having a faint, characteristic odor. |
2 | Solubility | Complies | Freely soluble in alcohol, in chloroform, in ether and in vegetable oils. Insoluble in water & in propylene glycol Very soluble in acetone. |
3 | Identification (by IR) | Comples | IR Spectra of the sample should be concomitant with IR spectra of standard. |
4 | Identification by chromatogram | Complies | The retention time of the BHT peak of the sample solution corresponds to that of the std. solution as obtained in the assay. The chromatographic profile of sample solution should exhibit only 1 major peak corresponding to the main compound.( |
5 | Identification (By Freezing point) | 70°C | 69°C-70°C |
6 | Identification (By UV absorbance test) | 86 | The solution should show an absorption maximum at 278 nm & the specific absorbance at the maximum should between 80 to 90. |
7 | Identification by Chemical test | Complies | A blue colour should develop. |
8 | Appearance of solution | Complies | The solution is clear and not more intensely colored than reference solution Y5 or BY5. |
9 | Assay (on Anhydrous basis) | 99.73% | 99.0%-101.5% |
10 | Residue on ignition /Sulfated ash | 0.001% | Not more than 0.002% |
11 | Organic impurities : p-Cresol or m- cresol | Not detected | NMT 0.1% |
12 | Organic impurities : 3-tert-Butyl-4Hydroxyanisole (BHA) | Not detected | NMT 0.1% |
13 | Organic impurities: 3,5-Di-tert-butyl-4-hydroxybenzoic acid | Not detected | NMT 0.1% |
14 | Organic impurities : 2-tert-Butyl-4-methylphenol or 2-tert-butyl-5-methylphenol | Not detected | NMT 0.1% |
15 | Organic impurities : 3,5-Di-tert-butyl-4-hydroxybenzaldehyde | Not detected | NMT 0.1% |
16 | Organic impurities : 4,6-Di-tert-butyl-m-cresol | Not detected | NMT 0.1% |
17 | Organic impurities : 2,6-Di-tert-butyl-phenol | Not detected | NMT 0.1% |
18 | Organic impurities : Any unspecified impurity | 0.002% | NMT 0.1% |
19 | Organic impurities : total impurities | 0.006% | NMT 0.7% |
20 | Related substances (By TLC) | Less than 0.5% | 0.5% max. |
21 | Water | 0.02% | NMT 0.1% |
22 | Arsenic | Less than 0.0001% | NMT 0.0001% |
23 | Sulfate | Less than 0.002% | NMT 0.002% |
24 | Free phenol | Less than 0.02% | NMT 0.02% |