Monographs: Pharmaceutical substances: Lindane (Lindanum)Molecular formula. C6H6Cl6 Relative molecular mass. 290.8 Graphic formula. Chemical name. γ-1,2,3,4,5,6-Hexachlorocyclohexane; (1α,2α,3β,4α,5α,6β)-1,2,3,4,5,6-hexachlorocyclohexane; CAS Reg. No. 58-89-9. Other names. Gamma benzene hexachloride; gammahexachlorcyclohexane. Description. A white, crystalline powder; odour, slight. Solubility. Practically insoluble in water; soluble in dehydrated ethanol R and ether R. Category. Pediculicide; scabicide. Storage. Lindane should be kept in a well-closed container. Requirements Definition. Lindane contains not less than 99.0% and not more than 100.5% of C6H6Cl6, calculated with reference to the anhydrous substance. Identity tests
Congealing temperature. Not below 112.0°C. Free chlorides. For the preparation of the test solution shake 1.2 g with 30 mL of water for 1 minute, and filter. To the filtrate add 10 mL of nitric acid (~130 g/l) TS and proceed as described under 2.2.1 Limit test for chlorides; the chloride content is not more than 0.2 mg/g. Sulfated ash. Not more than 1.0 mg/g. Water. Determine as described under 2.8 Determination of water by the Karl Fischer method, Method A, using about 1 g of the substance; the water content is not more than 5.0 mg/g. Acidity or alkalinity. Boil 1.5 g with 30 mL of water for 1 minute and filter. To 10 mL of the filtrate add 2 drops of phenolphthalein/ethanol TS and titrate with carbonate-free sodium hydroxide (0.01 mol/l) VS; not more than 0.2 mL is required to obtain a pink colour. Add 0.4 mL of hydrochloric acid (0.01 mol/l) VS and 5 drops of methyl red/ethanol TS; the colour changes to orange. Assay. To about 0.4 g, accurately weighed, add 25 mL of ethanol (~750 g/l) TS and warm on a water-bath until dissolved. Cool, add 10 mL of potassium hydroxide/ethanol (1 mol/l) VS, swirl gently, and allow to stand for 10 minutes. Dilute to 150 mL with water, neutralize with nitric acid (~130 g/l) TS, add 10 mL in excess of the acid, followed by 50 mL of silver nitrate (0.1 mol/l) VS. Filter, wash the residue with water, and titrate the combined filtrate and washings with ammonium thiocyanate (0.1 mol/l) VS, using ferric ammonium sulfate (45 g/l) TS as indicator. Repeat the operation without the substance being examined and make any necessary corrections. Each mL of silver nitrate (0.1 mol/l) VS is equivalent to 9.693 mg of C6H6Cl6.
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