| Benzyl alcohol USP-NF/Ph.Eur/BP PARENTEX 200LT-SS drum | |||
| P0290LL200 | 44372C205IX | ||
| USP-NF/Ph.Eur/BP PARENTEX | 44372C2 | ||
| 100-51-6 | 106401 | ||
| C7H8O | September 2024 | ||
| 108.10 | August 2026 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | Clear, colorless, oily liquid. Boils at 206°C, without decomposition. Is neutral to litmus. | Clear, colorless, oily liquid. Boils at about 206°C, without decomposition. Is neutral to litmus. | USP-NF/Ph.Eur/BP |
| 2 | Solubility | Complies | Soluble in water, miscible with ethanol (96 %) and with fatty and essential oils with ether, and with chloroform. Freely soluble in 50% alcohol | USP-NF/Ph.Eur/BP |
| 3 | Relative density, 20°C | 1.045 | 1.043-1.049 | Ph.Eur/BP |
| 4 | Identification by IR | Complies | The IR absorption spectra of a substance should concomitant with the corresponding standard | USP-NF/Ph.Eur/BP |
| 5 | Appearance of solution | Complies | The solution is clear and colourless. | Ph.Eur/BP |
| 6 | Clarity of solution | Complies | The sample solution shows the same clarity as that of water, or its opalescence is not more pronounced than that of refrerence suspension 1. | USP-NF |
| 7 | Colour of solution | Complies | Sample solution has the color of water. | USP-NF |
| 8 | Refractive index,20° C | 1.540 | 1.538-1.541 | USP-NF/Ph.Eur/BP |
| 9 | Assay | 99.49% | 98.0-100.5% | USP-NF/Ph.Eur/BP |
| 10 | Acidity | 0.2 mL of 0.1M sodium hydroxide required | NMT 1 mL of 0.1M sodium hydroxide is required to change the color of the indicator to pink. | USP-NF/Ph.Eur |
| 11 | Fats & Fixed oils (Peroxide value) | 0.61 | NMT 5 | USP-NF/Ph.Eur/BP |
| 12 | Residue on evaporation | 0.006% | NMT 0.05% | USP-NF/Ph.Eur/BP |
| 13 | Related substances: Benzaldehyde | 0.04% | NMT 0.05% | USP-NF/Ph.Eur/BP |
| 14 | Related substances: Cyclohexylmethanol | Not detected | NMT 0.10% | USP-NF/Ph.Eur/BP |
| 15 | Related subtances: Sum of the areas of other peaks with a relative retention time less than that of Benzyl alcohol | 0.0014% | NMT 0.02% | USP-NF/Ph.Eur/BP |
| 16 | Related substances: Sum of the areas of other peaks with a relative retention time greater than that of Benzyl alcohol | 0.0003% | NMT 0.2% | USP-NF/Ph.Eur/BP |
| 17 | Total arobic microbial count | Less than 100 CFU/ml | NMT 100 CFU/ml | In-house |
| 18 | Total combined yeast and molds count | Less than 100 CFU/ml | NMT 100 CFU/ml | In-house |
| 19 | Bacterial endotoxins | Less than 2.5 EU/ml | NMT 2.5 EU/ml | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, Ph.Eur, BP 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.
