Edition: BP 2025 (Ph. Eur. 11.6 update)
DEFINITION
Magnesium Chloride Injection is a sterile solution of Magnesium Chloride Hexahydrate in Water for Injections.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of magnesium chloride hexahydrate, MgCl2,6H2O
95.0 to 105.0% of the stated amount.
CHARACTERISTICS
A clear, colourless solution.
IDENTIFICATION
Yields the reactions characteristic of magnesium salts and of chlorides, Appendix VI.
Acidity or alkalinity
pH, 5.0 to 8.0, Appendix V L.
ASSAY
Dilute a volume containing 2.5 g of Magnesium Chloride Hexahydrate to 100 mL with water. To 20 mL of this solution add 10 mL of ammonia buffer pH 10.9 and titrate with 0.1M 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 0.1M disodium edetate VS is equivalent to 20.33 mg of MgCl2,6H2O.
LABELLING
The strength is stated as the percentage w/v of Magnesium Chloride Hexahydrate and as the approximate concentration of magnesium ions (Mg2+) in millimoles per mL.
For a preparation containing 10% w/v of Magnesium Chloride Hexahydrate, the concentration of magnesium ions is approximately 0.5 millimoles per millilitre (0.5 mmol Mg2+/mL).
