Monographs: Pharmaceutical substances: Dilute hydrochloric acid (Acidum hydrochloricum dilutum)Description. A colourless liquid; odourless. Category. Acidifying agent. Storage. Dilute hydrochloric acid should be kept in a rightly closed container. Requirements Dilute hydrochloric acid contains not less than 9.5% m/m and not more than the equivalent of 10.5% m/mof HCl. Identity tests
Mass density: ρ20 = 1.043-1.049 g/mL. Heavy metals. For the preparation of the test solution evaporate 4 g to dryness on a water-bath, add 2 mL of acetic acid (~60 g/l) PbTS, dilute to 40 mL and mix; determine the heavy metals content as described under 2.2.3 Limit test for heavy metals, Method A; not more than 5 μg/g. Arsenic. Dilute 17 mL to 20 mL with water. Use 2 mL and proceed as described under 2.2.5 Limit test for arsenic; not more than 0.5 μg/g. Bromides and iodides. To 10 mL add 1 mL of chloroform R and add cautiously, a drop at a time with constant stirring, chlorine TS which has been diluted with an equal volume of water; the chloroform remains free from even a transient yellow, orange, or violet colour. Free bromine and chlorine. To 10 mL add 1 mL of potassium iodide (80 g/l) TS and 1 mL of chloroform R, and shake the mixture; the chloroform remains free from any violet colour for at least 1 minute. Sulfites. Mix 3 mL with 5 mL of water and add 5 drops of barium chloride (50 g/l) TS and 2 drops of iodine (0.05 mol/l) VS; no turbidity is produced and the colour of the iodine is not completely discharged. Sulfates. To 90 mL add 40 mg of sodium hydrogen carbonate R and evaporate to dryness on a water-bath; dissolve the residue in 20 mL of water and proceed as described under 2.2.2 Limit test for sulfates; the sulfate content is not more than 5 μg/g. Residue on ignition. Place 10 g in a porcelain dish and evaporate to dryness on a water-bath. Ignite the residue to constant mass; not more than 0.1 mg/g. Assay. Add about 2 mL, accurately weighed, to 20 mL of water and titrate with sodium hydroxide (1 mol/l) VS, using methyl red/ethanol TS as indicator. Each mL of sodium hydroxide (1 mol/l) VS is equivalent to 36.46 mg of HCl. |