Magnesium Sulphate InjectionGeneral

Magnesium Sulphate Injection
General Notices
DEFINITION
Magnesium Sulphate Injection is a sterile solution of Magnesium Sulphate Heptahydrate in
Water for Injections.
The injection complies with the requirements stated under Parenteral Preparations and with
the following requirements.
Content of magnesium sulphate heptahydrate, MgSO4,7H2O
95.0 to 105.0% of the stated amount.
CHARACTERISTICS
A clear, colourless solution.
IDENTIFICATION
Yields the reactions characteristic of magnesium salts and of sulphates, Appendix VI.
TESTS
Acidity or alkalinity
pH of the injection diluted, if necessary, to contain 5% w/v of Magnesium Sulphate
Heptahydrate, 5.5 to 7.0, Appendix V L.
ASSAY
Dilute a volume containing 1.25 g of Magnesium Sulphate Heptahydrate to 100 ml with water.
To 20 ml of this solution add 10 ml of ammonia buffer pH 10.9 and titrate with 0.05M disodium
edetate VS using 0.1 g of mordant black 11 triturate as indicator, until the pink tint is
discharged from the blue colour. Each ml of 0.05M disodium edetate VS is equivalent to 12.32
mg of MgSO4,7H2O.
LABELLING
The strength is stated as the percentage w/v
of Magnesium Sulphate Heptahydrate and as
the approximate concentration of magnesium ions (Mg2+) in millimoles per ml.
For a preparation containing 50% w/v
of Magnesium Sulphate Heptahydrate (MgSO4,7H2O)
the concentration of magnesium ions is approximately 2 millimoles per millilitre (2 mmol Mg2+/
ml).

結果 (中文) 1:

镁硫酸盐注射液一般注意事项定义镁硫酸盐注射液是硫酸镁在无菌溶液注射用水的。该注射液符合所述下注射制剂与要求以下的要求。含量的镁硫酸盐水合物，MgSO4，7H2O95.0 到 105.0%的数额。特点无色透明的解决方案。鉴定收益率反应特性的镁盐和硫酸盐，附录六。测试酸度或碱度ph 值的注射液稀释后，如果有必要，含有 5%的硫酸镁 w /v七水硫酸锌，5.5 ~ 7.0，附录 V L.测定稀释含镁七水硫酸镁对用水 100 毫升的 1.25 g 的体积。到 20 毫升的这种解决方案添加 10 毫升的氨缓冲 pH 10.9 和滴定与 0.05 M 二钠使用的媒介黑 11 0.1 g 乙二胺四乙酸四 VS 研制作为指标，直到粉红色色调是出院的蓝色的颜色。每毫升 0.05 M 二钠乙二胺四乙酸四 VS 等于 12.32MgSO4 7H2O 毫克。标签强度表示为百分比 w /v硫酸镁和作为近似浓度的镁离子 （Mg2 +） 在毫摩尔每毫升。为制备含 50 %w /v水硫酸镁 (MgSO4，7H2O)镁离子的浓度是大约 2 毫摩尔每毫升 (2 mmol Mg2 +毫升）。

結果 (中文) 3:

硫酸镁注射液一般通知定义硫酸镁注射液是一种无菌溶液中硫酸镁注射用水。该注射液符合注射制剂和所述的要求以下要求。七水合硫酸镁的含量，mgso4,7h2o95至105%的规定数额。特点一个清晰、无色溶液。识别收益率的反应特性的镁盐和硫酸盐，附录VI。试验酸碱度如果需要的话，注射稀释液中含有5%瓦特/体积的硫酸镁七、5.5至7、附录V L。测定稀释体积含1.25克的硫酸镁100毫升水。对该溶液20毫升加入氨缓冲液pH 10.9和滴定0.05M二钠10毫升依地酸比使用0.1克媒黑色11个triturate作为指标，直到粉红色彩从蓝色排放。每毫升0.05M乙二胺四乙酸二钠比等于12.32毫克mgso4,7h2o。标签力量是以百分比表示的七水合硫酸镁和镁离子（Mg2+）浓度大约在毫克每毫升。对于含有50%瓦特/体积的准备七水硫酸镁（mgso4,7h2o）镁离子的浓度约为2毫克每毫升（2 mmol/L Mg2+／毫升）。