CASR |
: | 121-54-0 |
Molecular Formula |
: | C27H42NO2Cl |
Molecular Weight |
: | 448.1 |
| Specifications | |
|---|---|
| Description: | White or yellowish white crystals or powder, having a mild odor. Its solution (1 in 100) is slightly alkaline to litmus. |
| Solubility: | 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. |
| Identification (By chemical test 1): | A white precipitate, which is insoluble in 2N nitric acid but soluble in 6N ammonium hydroxide,should form. |
| Identification (By chemical test 2): | A blue colour should develop in the lower layer. |
| Identification (By IR): | IR spectra of the sample should be concomitant with IR spectra of the standard. |
| Identification (by Assay): | The retention time of the major peak of the sample solution corresponds to the standard solution, as obtained in the Assay. |
| Identification(By Melting point): | 158°C - 164°C, after drying at 105°C for 4 Hr. |
| Identification (By TLC): | 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. |
| Appearance of Solution: | Solution S is Clear and not more intensely coloured than reference solution Y6. |
| Assay (By HPLC, on dried basis): | 97.0% - 103.0% |
| Assay (By Titration, on dried basis): | 97.0% to 103.0% |
| Residue on ignition /Sulfated ash: | NMT 0.1% |
| Organic impurities : Total impurities: | NMT 1.0% |
| Loss on drying (105 °C, 4 hr): | NMT 5.0% |
| Acidity or Alkalinity: | The solution should orange-red |
| Volatile bases and salts of volatile bases: | NMT 50ppm |
| Bacterial endotoxins: | NMT 2.5 EU/mg |
| Total aerobic microbial count: | NMT 100 CFU/gm |
| Total combined yeast and molds count: | NMT 10 CFU/gm |
