维生素K1 BP2010翻译

维生素K1 BP2010翻译 Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume III Formulated Preparations: Specific Monographs Phytomenadione Injection Phytomenadione Injection General Notices Action and use Vitamin K analogue. DEFINITION Phytomenadione Injection is a sterile preparation of Phytomenadione in Water for Injections. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of phytomenadione, C31H46O2 90.0 to 115.0% of the stated amount. CHARACTERISTICS A clear to slightly opalescent liquid when maintained at a temperature below 25?. IDENTIFICATION A. Dilute with absolute ethanol to produce a solution containing 0.01% w/v of Phytomenadione. The light absorption of the solution, Appendix II B, in the range 230 to 350 nm exhibits a maximum at 328 nm and a minimum at 292 nm. B. Dilute a quantity of the solution used in test A with absolute ethanol to produce a solution containing 0.001% w/v of Phytomenadione. The light absorption of the solution, Appendix II B, in the range 230 to 350 nm exhibits maxima at 245, 249, 263 and 271 nm and minima at 256 nm and 266 nm. TESTS Acidity or alkalinity pH, 5.0 to 7.5, Appendix V L. ASSAY Carry out in subdued light the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.01% w/v of phytomenadione EPCRS in the mobile phase. For solution (2) dilute a volume of the injection containing 10 mg of Phytomenadione with sufficient of the mobile phase to produce 100 ml. The chromatographic procedure may be carried out using (a) a stainless steel column (20 cm × 4 mm) packed with octadecylsilyl silica gel for chromatography (5 μm) (Spherisorb ODS 1 is suitable), (b) a mixture of 95 volumes of ethanol (96%) and 5 volumes of water as the mobile phase with a flow rate of 1.5 ml per minute and (c) a detection wavelength of 254 nm. Calculate the content of C31H46O2 using the declared content of C31H46O2 in phytomenadione EPCRS. 英国药典2009 英国药典卷三 制剂:各论 维生素K1注射液 维生素K1注射液 一般事项 作用和用途 维生素K类似物。 定义 维生素K1注射液是维生素K1溶于注射用水的无菌制剂。该注射液需符合非肠道制剂项下、以及下述的要求。 维生素K1的含量，CHO 31462 标示量的90.0至115.0,。 性状 储存在低于25?的温度下时，为清晰至微乳白色的液体。 鉴定 A. 用无水乙醇稀释，得到含有0.01,w / v的维生素K1溶液。溶液的光吸收位于230至350nm的范围内，最大值在328 nm，最小为292纳米，附录II B。 B. 取鉴定A的待测液，用无水乙醇稀释至含0.001,w / v的维生素K1溶液。溶液的光吸收位于230至350nm的范围内，最大值在245,249,263,271nm，最小为256,266nm，附录II B。 检验 酸度或碱度 pH值，5.0?7.5，附录?L。 含量测定 在弱光下进行液相色谱法，附录III D，使用以下溶液:溶液(1)为含有0.01,w / v的维生素K1 EPCRS的流动相。溶液(2)用足够的流动相稀释含10mg维生素K1的注射液至100ml。 色谱过程按照如下过程进行:(a)在不锈钢柱(20厘米*4毫米)中装填色谱用十八烷基键合硅胶(5微米)(可用Spherisorb ODS 1)，(b)以体积比95/5的乙醇(96,)/水混合液为流动相，流速为1.5ml/min,(c)检测波长为254nm。 计算CHO的含量，以标示的维生素K1中CHO的含量计。 3146231462