| Butylated hydroxyanisole Excipient grade 500GM | |||
| 80370SG500 | 142961706FO | ||
| Excipient Grade | 1429617 | ||
| 25013-16-5 | 21224 | ||
| C11H16O2 | June 2015 | ||
| 180.25 | May 2018 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Characters | A slightly yellow crystalline powder having faint chracteristic. | 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 soluble in methylene chloride, freely sol in alcohol, in propylene glycol, chloroform, ether and in fatty oils. it dissolves in dilute solution of alkali hydroxide |
| 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 10 ppm | 10ppm max |
| 13 | Residue on ignition | 0.0089% | Not more than 0.01% |
| 14 | Assay | 99.16% | Not less than 98.5% |
| 15 | Methanol as residual solvent | Not detected | 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.
