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Meets USP-NF, EP, BP and JP testing specifications
| Product Code | TC554M |
|---|
| Molecular weight | 448.09 |
|---|---|
| Molecular formula | C27H42CINO2 |
| CAS No. | 121-54-0 |
| Appearance (USP) | White crystals |
|---|---|
| Appearance (JP) | Colourless or white crystals. |
| Appearance (BP, EP) | White or yellowish-white powder |
| Solubility (JP) | Very soluble in ethanol (95%), freely soluble in water, and practically insoluble in diethyl ether. |
| Solubility (USP) | Soluble in water, in alcohol, and in chloroform; slightly soluble in ether |
| Solubility (BP, EP) | Very soluble in water and in ethanol (96%), freely soluble in methylene chloride |
| Identification 1 : (JP) | Develops a red color. |
| Identification A : (BP, EP) | 158-164°C (after drying at 105°C for 4 h) |
| Identification A : (USP) | A white precipitate which is insoluble in 2N nitric acid but soluble in 6N ammonium hydroxide, is formed |
| Identification 2 : (JP) | The chloroform layer turns colorless. |
| Identification B, TLC (BP, EP) | 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 |
| Identification B, FTIR (USP) | Matches with the standard pattern |
| Identification 3, UV (JP) | Both spectra exhibit similar intensities of absorption at the same wavelengths. |
| Identification C (BP, EP) | A blue colour develops in the lower layer |
| Identification C (USP) | The retention time of the major peak of the sample solution corresponds to the standard solution, as obtained in the assay |
| Identification 4 (JP) | A white precipitate is produced. This precipitate does not dissolve on addition of dilute nitric acid, but dissolves on addition of ammonia TS. |
| Identification D : chlorides (BP, EP) | The solution gives reaction (a) of chlorides |
| Melting point (JP) | 158-164°C (after drying) |
| Appearance of solution (BP, EP) | Solution S (10% solution)is clear and not more intensely coloured than reference solution Y6 |
| Ammonium (JP) | The evolving gas dose not change moistened red litmus paper to blue. |
| Loss on drying (at 105°C, 4h) : (JP, BP, EP, USP) | <= 5.00% |
| Residue on ignition (JP, USP) | <= 0.10% |
| Acidity or alkalinity (BP, EP) | Complies |
| Volatile bases and salts of volatile bases (EP, BP) | <= 0.0050% |
| Sulfated ash (BP, EP) | <= 0.10% |
| Residue on ignition (USP) | <= 0.10% |
| Organic impurities, system suitability, HPLC : RSD (USP) | <= 5.0% |
| Organic impurities, HPLC : total impurities (USP) | <= 1.0% |
| Assay, system suitability, HPLC : Resolution (USP) | >= 7.0 between the benzethonium and methylbenzethonium peak |
| Assay, system suitability, HPLC : RSD | <= 1.0% for the benzethonium peak |
| Assay (HPLC, on dried basis) : (USP) | 97.0 - 103.0% |
| Assay (KIO3 Titration, dried substance) : (BP, EP) | 97.0 - 103.0% |
| Assay (Tetraphenylboron Titration, dried substance) : (JP) | min. 97.0% |
| Store below | 30°C. |
|---|---|
| Shelf life | 48 months. |
| Product Name | Benzethonium chloride |
|---|---|
| SKU | TC554M |
| CAS No | 121-54-0 |
| Molecular formula | C₂₇H₄₂ClNO₂ |
| Molecular Weight | 448.09 |
| Storage | Below 30°C |
| Shelf Life | 4 Years |