【英文版】USP32富马酸亚铁含量的.pdf

1美国药典32版（USP32）英文版 富马酸亚铁含量的测定 C4H2FeO4 169.90 2-Butenedioic acid, (E)-, iron(2+) salt. 【2-反丁烯二酸，（E）-亚铁盐】 Iron(2+) fumarate 【富马酸亚铁】 » Ferrous Fumarate contains not less than 97.0 percent and not more than 101.0 percent of C4H2FeO4, calculated on the dried basis. Packaging and storage— Preserve in well-closed containers. Identification【鉴别】— A: To 1.5 g add 25 mL of dilute hydrochloric acid (1 in 2). Dilute with water to 50 mL, heat to dissolve, then cool, filter on a fine-porosity【细孔径】, sintered-glass crucible【烧结玻璃坩埚】, wash the precipitate【沉淀】with dilute hydrochloric acid (3 in 100), saving the filtrate for Identification test B, and dry the precipitate at 105℃: the IR absorption【外红吸收】of a potassium bromide【溴化钾】dispersion of the dried precipitate so obtained exhibits maxima【最大值】only at the same wavelengths as that of a similar preparation of USP Fumaric Acid RS. B: A portion of the filtrate obtained in the preceding test responds to the tests for Iron 191 . Loss on drying 731— Dry it at 105℃for 16 hours: it loses not more than 1.5% of its weight. Sulfate【硫酸盐】— 2Transfer【移取】1.0 g to a 250-mL beaker【烧杯】, add 100 mL of water, and heat on a steam bath【蒸气浴】, adding hydrochloric acid dropwise【逐滴加入盐酸】, until complete solution【溶液】is effected (about 2 mL of the acid will be required). Filter【过滤】the solution if necessary, and dilute【稀释】the filtrate【滤液】with water to 100 mL. Heat the filtrate to boiling【沸腾】,add 10 mL of barium chloride TS【氯化钡试液，TS=Test Solution 试液】, warm on a steam bath for 2 hours, cover, and allow to stand for【静置】16 hours. (If crystals【结晶】of ferrous fumarate form【形成】, warm the solution on the steam bath to dissolve【溶解】them.) Pass the solution through ashless filter paper【无灰滤纸】, wash the residue【滤渣】with hot water until, with the addition of ammonium sulfide TS【硫化铵试液，TS=Test Solution 试液】, a black precipitate【沉淀】is no longer formed in the filtrate, and transfer the paper containing the residue to a tared crucible【已称重的坩埚】. Char【碳化】the p