文档介绍:葡萄糖注射液检验方法
Glucose Intravenous Infusion
葡萄糖静脉输液
General Notices
Glucose Injection
DEFINITION定义
Glucose Intravenous Infusion is a sterile solution of Anhydrous Glucose or Glucose in Water for Injections.
葡萄糖静脉输液是无水葡萄糖或葡萄糖溶于注射用水的无菌溶液。
The intravenous plies with the requirements stated under Parenteral Preparations and with the following requirements.
该静脉输液应符合非肠道制剂下的要求和下列要求。
Content of glucose, C6H12O6
to % of the stated amount.
葡萄糖的含量, C6H12O6 --% .
CHARACTERISTICS
A colourless solution. Solutions containing the equivalent of 200 g per litre or more of glucose, C6H12O6, may be not more than faintly straw coloured. 性状无色溶液。每ml含200g或更过葡萄糖,C6H12O6,的溶液,颜色可以不超过浅黄色。
IDENTIFICATION鉴别
A. Heat with cupri-tartaric solution R1. A red precipitate is produced.
B. The solution prepared as directed in the Assay is dextrorotatory.
A. 当与酒石酸铜溶液 R1加热, 产生红色沉淀。
B. 含量下制备的溶液呈右旋性。
TESTS
Acidity
pH, to , Appendix V L, when determined on a solution diluted, if
necessary, with water for injections, to contain not more than the equivalent of 5% w/v of glucose, C6H12O6, and to which ml of a saturated solution of potassium chloride has been added for each 100 ml of solution.
酸度
溶液的pH, --, 附录 V L,必要时,溶液用注射用水稀释成5% w/v的葡萄糖溶液,。
5-Hydroxymethylfurfural and related substances
Dilute a volume co