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BIOREX PHARMACEUTICALS ISLAMABAD

SOP/QC / T001

RAW MATERIAL SAMPLING --------------------------------------------------------------------------------------------------------------------------Complexometric Titrations Aluminium To 20 ml of the prescribed solution in a 500 ml conical flask add 25 ml of 0.1M disodium edetate VS and 10 ml of a mixture of equal volumes of a 15.5% w/v solution of ammonium acetate and 2M acetic acid. Heat to boiling for 2 minutes, cool and add 50 ml of absolute ethanol and 3 ml of a freshly prepared 0.025% w/v solution of dithizone in absolute ethanol. Titrate the excess of disodium edetate with 0.1M zinc sulphate VS until the colour changes from greenish blue to reddish violet. Each ml of 0.1M disodium edetate VS is equivalent to 2.698 mg of Al. Bismuth Dilute the prescribed solution in nitric acid to 250 ml with water and unless otherwise directed add, with shaking, 13.5M ammonia dropwise until cloudiness is first observed. Add 0.5 ml of nitric acid and heat to 70, maintaining the solution at this temperature until the solution becomes completely clear. Add about 50 mg of xylenol orange triturate and titrate with 0.1M disodium edetate VS until the colour changes from pinkish violet to yellow. Each ml of 0.1M disodium edetate VS is equivalent to 20.90 mg of Bi. Calcium In a 500 ml conical flask dilute the prescribed solution with water to 300 ml, add 6 ml of 10M sodium hydroxide and about 15 mg of calconcarboxylic acid triturate and titrate with 0.1M disodium edetate VS until the colour changes from violet to full blue. Each ml of 0.1M disodium edetate VS is equivalent to 4.008 mg of Ca. Lead In a 500 ml conical flask dilute the prescribed solution to 200 ml with water and add about 50 mg of xylenol orange triturate and sufficient hexamine to produce a violet-pink colour. Titrate with 0.1M disodium edetate VS until the colour changes to yellow. Each ml of 0.1M disodium edetate VS is equivalent to 20.72 mg of Pb. Magnesium In a 500 ml conical flask dilute the prescribed solution to 300 ml with water or dissolve the prescribed quantity of the substance being examined in 5 to 10 ml of water or in the minimum volume of 2M hydrochloric acid and dilute to 50 ml with water. To the resulting solution add 10 ml of ammonia buffer pH 10.0 and about 50 mg of mordant black 11 triturate. Heat to 40 and titrate at this temperature with 0.1M disodium edetate VS until the colour changes from violet to full blue. Each ml of 0.1M disodium edetate VS is equivalent to 2.431 mg of Mg. Zinc In a 500 ml conical flask dilute the prescribed solution to 200 ml with water and add about 50 mg of xylenol orange triturate and sufficient hexamine to produce a violet-pink colour. Add a further 2 g of hexamine and titrate with 0.1M disodium edetate VS until the colour changes to yellow. Each ml of 0.1M disodium edetate VS is equivalent to 6.54 mg of Zn.

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