BP2003版炔诺酮质量标准.docxVIP

BP2003版 炔诺酮Norethisterone Acetate(Ph Eur monograph 0850) ?C22H28O3340.551-98-9 ? Ph Eur? ? DEFINITION ? 3-Oxo-19-nor-17a-pregn-4-en-20-yn-17-yl acetate.? Content ? 98.0 per cent to 101.0 per cent (dried substance). ? CHARACTERS ? Appearance ? White or yellowish-white, crystalline powder.? Solubility ? Practically insoluble in water, freely soluble in methylene chloride, soluble in alcohol.? It shows polymorphism. ? IDENTIFICATION ? Infrared absorption spectrophotometry (2.2.24).? Preparation? Discs.? Comparison? Norethisterone acetate CRS.? If the spectra show differences, dissolve the substan