| Benzethonium chloride USP/Ph.Eur/BP PARENTEX 100GM | |||
| P0280SG100 | 44470B216IX | ||
| USP/Ph.Eur/BP PARENTEX | 44470B2 | ||
| 121-54-0 | 106535 | ||
| C27H42NO2Cl | September 2024 | ||
| 448.1 | August 2026 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White powder, having a mild odor. Its solution (1 in 100) is slightly alkaline to litmus. | White or yellowish white crystals or powder, having a mild odor. Its solution (1 in 100) is slightly alkaline to litmus. | USP/Ph.Eur/BP |
| 2 | Solubility | Complies | Soluble in water, in alcohol, ethanol (96%) and in chloroform ; slightly soluble in ether. freely soluble in methylene chloride. An aqueous solution froths copiously when shaken. | USP/Ph.Eur/BP |
| 3 | Identification (By chemical test 1) | Complies | A white precipitate, which is insoluble in 2N nitric acid but soluble in 6N ammonium hydroxide,should form. | USP/Ph.Eur/BP |
| 4 | Identification (By chemical test 2) | Complies | A blue colour should develop in the lower layer. | Ph.Eur/BP |
| 5 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. | USP |
| 6 | Identification (by Assay) | Complies | The retention time of the major peak of the sample solution corresponds to the standard solution, as obtained in the Assay. | USP |
| 7 | Identification(By Melting point) | 162.2°C | 158°C - 164°C, after drying at 105°C for 4 Hr. | Ph.Eur/BP |
| 8 | Identification (By TLC) | Complies | The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with the reference solution. | Ph.Eur/BP |
| 9 | Appearance of Solution | Complies | Solution S is Clear and not more intensely coloured than reference solution Y6. | Ph.Eur/BP |
| 10 | Assay (By HPLC, on dried basis) | 99.9% | 97.0% - 103.0% | USP |
| 11 | Assay (By Titration, on dried basis) | 99.5% | 97.0% to 103.0% | Ph.Eur/BP |
| 12 | Residue on ignition /Sulfated ash | 0.04% | NMT 0.1% | USP/Ph.Eur/BP |
| 13 | Organic impurities : Total impurities | Not detected | NMT 1.0% | USP |
| 14 | Loss on drying (105 °C, 4 hr) | 2.6% | NMT 5.0% | USP/Ph.Eur/BP |
| 15 | Acidity or Alkalinity | Complies | The solution should orange-red | Ph.Eur/BP |
| 16 | Volatile bases and salts of volatile bases | Less than 50ppm | NMT 50ppm | Ph.Eur/BP |
| 17 | Bacterial endotoxins | Less than 2.5 EU/mg | NMT 2.5 EU/mg | In-House |
| 18 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-House |
| 19 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm | In-House |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, 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.
