Potassium Chloride and Glucose Intravenous Infusion

Potassium Chloride and Dextrose Injection; Potassium Chloride and Glucose Injection; Potassium Chloride and Dextrose Intravenous Infusion

 

Definition

 

Potassium Chloride and Glucose Intravenous Infusion is a sterile solution of Potassium Chloride and either Anhydrous Glucose or Glucose in Water for Injections.

 

The intravenous infusion complies with the requirements stated under Parenteral Preparations and with the following requirements.

 

Content of potassium chloride, KCl

 

95.0 to 105.0% of the stated amount.

 

Content of glucose, C6H12O6

 

95.0 to 105.0% of the stated amount.

 

Characteristics

 

A colourless or faintly straw-coloured solution.

 

Identification

 

A.    When heated with cupri-tartaric solution R1 a copious precipitate of copper(I) oxide is produced.

 

B.    The residue on evaporation yields the reactions characteristic of potassium salts and of chlorides, Appendix VI.

 

Acidity

 

pH, 3.5 to 6.5, Appendix V L.

 

5-Hydroxymethylfurfural and related substances

 

Dilute a volume containing 1.0 g of glucose, C6H12O6, to 500 ml with water . The absorbance of the resulting solution at the maximum at 284 nm is not more than 0.25, Appendix II B.

 

Sodium

 

The content of Na is not more than 1.0% of the content of K, calculated from the content of potassium chloride determined in the Assay. Determine the content of Na by Method II for atomic emission spectrophotometry, Appendix II D, measuring at 589 nm and using sodium standard solution (200 ppm Na), diluted if necessary with water , to prepare the standard solutions.

 

Bacterial endotoxins

 

The endotoxin limit concentration is 0.25 IU per ml, Appendix XIV C.

 

Assay

 

For potassium chloride

 

Dilute appropriately with water  and determine by atomic emission spectrophotometry, Appendix II D, measuring at 767 nm and using potassium standard solution (600 ppm K), suitably diluted with water , to prepare the standard solutions.

 

For glucose

 

To a quantity containing 2 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 measure 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 quantity of the intravenous infusion taken for assay.

 

Labelling

 

The strength is stated as the percentages w/v of Potassium Chloride and of glucose, C6H12O6.

 

When the preparation is intended for intravenous infusion, the label also states (1) that rapid infusion may be harmful; (2) the approximate concentrations, in millimoles per litre, of the potassium ions and the chloride ions and the number of grams per litre of glucose, C6H12O6.

 

For a preparation containing 0.3% w/v of Potassium Chloride, the concentration of each ion is stated as 40 millimoles per litre.