| Butylated Hydroxytoluene USP-NF/Ph.Eur PARENTEX 5KG | |||
| P0380SR500 | 44615G111JX | ||
| USP-NF/Ph.Eur PARENTEX | 44615G1 | ||
| 128-37-0 | 107452 | ||
| C15H24O | October 2024 | ||
| 220.35 | September 2027 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White, crystalline solid, having a faint, characteristic odor. | White, crystalline solid, having a faint, characteristic odor. | USP-NF |
| 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 | USP/Ph.Eur |
| 3 | Identification (by IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of standard | USP-NF |
| 4 | Identification by chromatogram | Complies | The retention time of the BHT peak of the sample solution corrresponds to that of the standard solution as obtained in the assay.The chromatographic profile of sample solution should exhibit only one major peak corresponding to the main compound | USP-NF |
| 5 | Identification (By Freezing point) | 69.4°C | 69°C - 70°C | Ph.Eur |
| 6 | Identification (By UV absorbance test) | 86.2 | The solution should show an absorption maximum at 278 nm & the specific absorbance at the maximum should between 80 to 90 | Ph.Eur |
| 7 | Identification by Chemical test | Complies | A blue colour should devlop | Ph.Eur |
| 8 | Appearance of Solution | Complies | The solution is clear and not more intensely coloured than reference solution Y5 to BY5. | Ph.Eur |
| 9 | Assay | 99.8% | 99.0% - 101.5% | USP-NF |
| 10 | Residue on ignition /Sulfated ash | 0.0003% | NMT 0.002% | USP-NF |
| 11 | Organic impurities : p-Cresol or m- cresol | Not detected | NMT 0.1% | USP-NF |
| 12 | Organic impurities : 3-tert-Butyl-4Hydroxyanisole (BHA) | Not detected | NMT 0.1% | USP-NF |
| 13 | Organic impurities: 3,5-Di-tert-butyl-4-hydroxybenzoic acid | Not detected | NMT 0.1% | USP-NF |
| 14 | Organic impurities : 2-tert-Butyl-4-methylphenol or 2-tert-butyl-5-methylphenol | Not detected | NMT 0.1% | USP-NF |
| 15 | Organic impurities : 3,5-Di-tert-butyl-4-hydroxybenzaldehyde | Not detected | NMT 0.1% | USP-NF |
| 16 | Organic impurities : 4,6-Di-tert-butyl-m-cresol | Not detected | NMT 0.1% | USP-NF |
| 17 | Organic impurities : 2,6-Di-tert-butyl-phenol | Not detected | NMT 0.1% | USP-NF |
| 18 | Organic Imupurities (Any unspecified impurity) | 0.008% | NMT 0.1% | USP-NF |
| 19 | Organic impurities : Total impurities | 0.01% | NMT 0.7% | USP-NF |
| 20 | Related substances (By TLC) | Less than 0.5% | NMT 0.5% | Ph.Eur |
| 21 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 22 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm | In-house |
| 23 | Bacterial endotoxin test | Less than 0.5 EU/mg | NMT 0.5 EU/mg | In-house |
| 24 | Residual Solvents (Methanol) | 0.2% | NMT 0.3% | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, Ph.Eur SPECIFICATION.
Actylis 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.
