1 | Characters | Yellowish waxy solid having faint characteristic | A white or slightly yellow or yellowish or slightly pinkish, waxy solid or crystalline powder having faint characteristic. |
2 | Solubility | Passes | Practically insoluble in water, very soll in methylene chloride, freely sol in alcohol, in propylene glycol, chloroform, ether and in fatty oils. it dissolves in dilute solution of alkali hydroxides. |
3 | Identification A by TLC test | Complies | To comply the test |
4 | Identification B by Chemical test | Complies | To comply the test |
5 | Identification,(C)By Chemical test | Complies | To comply the test |
6 | Identification by Chemical test | Complies | To comply the test |
7 | Identification by HPLC chromatogram | Complies | The retention times of 3-tert-butyl-4-hydroxyanisole and 2-tert-butyl-4-hydroxyanisole from the sample solution correspond to those from the standard solution, as obtained in the assay. |
8 | Appearance of solution | Passes | 10% solution in alcohol is clear and not more intensely coloured than intensity 5 of the range of refrence solution of the most appropriate colour. |
9 | Related substances By TLC (3-(1,1-Dimethylethyl)-4-methoxyphenol) | NMT 10% | 10% max. |
10 | Related substances By TLC (Hydroquinone) | NMT 0.2% | 0.2% max. |
11 | Related substances By TLC (Any other impurity) | NMT 0.5% | 0.5% max. |
12 | Heavy metals | NMT 10ppm | 10ppm max |
13 | Residue on ignition | 0.008% | Not more than 0.01% |
14 | Assay | 99.42% | Not less than 98.5% |
15 | Methanol as residual solvent | Not detected | 0.3% max |