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 infusion complies 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

95.0 to 105.0% of the stated amount.

葡萄糖的含量, C6H12O6应为标示量的95.0--105.0% . 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, 3.5 to 6.5, 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 0.30 ml of a saturated solution of potassium chloride has been added for each 100 ml of solution.

酸度

溶液的pH, 3.5--6.5, 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，并在溶液中按每100ml加入0.30ml饱和氯化钾溶液。

5-Hydroxymethylfurfural and related substances

Dilute a volume containing the equivalent of 1.0 g of glucose, C6H12O6, to 250 ml with water . The absorbance of the resulting solution at the maximum at 284 nm is not more than 0.25, Appendix II B.

5-羟甲基糠醛和有关物质

将含1.0g葡萄糖, C6H12O6,的供试品用水稀释至250ml，在最大吸收284 nm测溶液的吸光度, 附录II B. 吸光度应不超过0.25.

Bacterial endotoxins

The endotoxin limit concentration is 0.25 IU per ml, Appendix XIV C. Dilute infusions containing more than 5% w/v (50 g per litre) of Glucose with water BET to contain 5% w/v.

细菌内毒素

内毒素的限值为0.25 IU /ml, 附录XIV C。将浓度大于5%w/v（50g/l）葡萄糖的输液用BET水稀释成5%w/v。

ASSAY

To a volume containing the equivalent of 2 g to 5 g of glucose, C6H12O6, add 0.2 ml of 5M ammonia and sufficient water to produce 100 ml. Mix well, allow to stand for 30 minutes and determine the optical rotation in a 2-dm tube, Appendix V F. The observed rotation in degrees multiplied by 0.9477 represents the weight in g of glucose, C6H12O6, in the volume taken for assay.

向含2-- 5 g葡萄糖, C6H12O6, 的供试品中加入0.2 ml 的5M 氨水并加水至

100ml. 充分混合, 静置30 分钟，用2-dm管测旋光度，附录V F. 所得旋光度的度数乘以0.9477 即为所取体积的注射液中葡萄糖的重量，C6H12O6, g。LABELLING

The strength is stated as the equivalent number of grams of glucose, C6H12O6, per litre.

When Glucose Intravenous Infusion is required as a diluent for Injections or Intravenous Infusions of the Pharmacopoeia, Glucose Intravenous Infusion (50 g per litre) shall be used.

的克数表示。当要求葡萄糖静脉输液作为浓度用每升中相当于葡萄糖, C6H12O6

，

注射液或静脉输液的稀释剂时，应使用葡萄糖静脉输液（50g/升）。