(Ph. Eur. monograph 1515)
FeCl3,6H2O 270.3 10025-77-1
Preparation
Ferric Chloride Injection
DEFINITION
Content
98.0 per cent to 102.0 per cent.
CHARACTERS
Appearance
Crystalline mass or orange-yellow or brownish-yellow crystals, very hygroscopic.
Solubility
Very soluble in water and in ethanol (96 per cent), freely soluble in glycerol.
IDENTIFICATION
A. It gives reaction (a) of chlorides (2.3.1).
B. It gives reaction (c) of iron (2.3.1).
TESTS
Solution S
Dissolve 10 g in distilled water R and dilute to 100 mL with the same solvent.
Acidity
In a suitable polyethylene container, dissolve 3.0 g of potassium fluoride R in 15 mL of water R. Titrate with 0.1 M sodium hydroxide using 0.1 mL of phenolphthalein solution R as indicator until a pink colour is obtained. Add 10 mL of solution S and allow to stand for 3 h. Filter and use 12.5 mL of the filtrate. Not more than 0.30 mL of 0.1 M sodium hydroxide is
required to change the colour of the indicator to pink.
Free chlorine
Heat 5 mL of solution S. The vapour does not turn starch iodide paper R blue.
Sulfates (2.4.13)
Maximum 100 ppm.
Heat 15 mL of solution S on a water-bath and add 5 mL of strong sodium hydroxide solution R. Allow to cool and filter. Neutralise the filtrate to blue litmus paper R using hydrochloric acid R1 and evaporate to 15 mL.
Ferrous ions
Maximum 50 ppm.
To 10 mL of solution S, add 1 mL of water R, and 0.05 mL of potassium ferricyanide solution R followed by 4 mL of phosphoric acid R. After 10 min, any blue colour in the solution is not more intense than that in a standard prepared at the same time and in the same manner using 10 mL of water R and 1 mL of a freshly prepared 0.250 g/L solution of ferrous sulfate R.
ASSAY
In a conical flask with a ground-glass stopper, dissolve 0.200 g in 20 mL of water R. Add 10 mL of dilute hydrochloric acid R and 2 g of potassium iodide R. Allow the stoppered flask to stand for 1 h protected from light. Titrate with 0.1 M sodium thiosulfate, adding 5 mL of starch solution R towards the end of the titration.
1 mL of 0.1 M sodium thiosulfate is equivalent to 27.03 mg of FeCl3,6H2O.
STORAGE
In an airtight container, protected from light.
