| Butylated Hydroxyanisole USP-NF/Ph.Eur PARENTEX 1KG | |||
| P0370SR100 | 42778G131AX | ||
| USP-NF/Ph.Eur PARENTEX | 42778G1 | ||
| 25013-16-5 | 101594 | ||
| C11H16O2 | January 2024 | ||
| 180.25 | December 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | White crystalline powder, having a faint, charactersitic odor. | White or yellowish / slightly yellow or slightly pinkish waxy solid or crystalline powder, having a faint, characteristic odor. |
| 2 | Solubility | Complies | Freely soluble in alcohol, in propylene glycol, in chloroform and in ether, and in fatty oils. Practically insoluble in water. very soluble in methylene chloride. It dissolves in dilute solutions of alkali hydroxides. |
| 3 | Identification (By IR) | Complies | All peak positions determined for butylated hydroxyanisole are within 5cm-1 of those determined for 3-tert-Butyl-4-hydroxyanisole standard. |
| 4 | Identification (By Chromatography) | Complies | The retention time of the main peak of the sample solution corresponds to that of the standard solution. The chromatographic profile of the sample solution similar to that of the standard solution and exhibit only 1 major peak corresponding to BHA. |
| 5 | Identification (By TLC) | Complies | The principal spot in the chromatogram obtained with test solution (b) is similar in position, color and size to the principal spot in the chromatogram obtained with reference solution (a). |
| 6 | Identification (By chemical test 1) | Complies | After separation, the organic layer is red. |
| 7 | Identification (By chemical test 2) | Complies | A red color develops. |
| 8 | Assay(HPLC) | 99.70% | NLT 98.5% |
| 9 | Appearance of Solution | Complies | Solution is clear and not more intensely colored than intensity 5 of the range of reference solutions of the most appropriate color. |
| 10 | Related substances By TLC (3-(1,1-Dimethylethyl)-4-methoxyphenol) | Less than 10.0% | NMT 10.0% |
| 11 | Related substances By TLC (Hydroquinone) | Less than 0.2% | NMT 0.2% |
| 12 | Related substances By TLC (Any other impurity) | Less than 0.5% | NMT 0.5% |
| 13 | Residue on ignition /Sulfated ash | 0.005% | NMT 0.01% |
| 14 | Total aerobic microbial count | Less than 100CFU/gm | NMT 100CFU/gm |
| 15 | Total Yeast and mold count | Less than 100CFU/gm | NMT 100CFU/gm |
| 16 | Escherichia coli | Absent/gm | Should be absent/gm |
| 17 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm |
| 18 | Residual solvent as n-Hexane | 12 ppm | NMT 200ppm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, 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.
