EUROPEAN PHARMACOPOEIA 10.0 Sodium cromoglicate ASSAY Dissolve 50.0 mg in water R and dilute to 50 mL with the same solvent. Titrate with 0.1 M silver nitrate determining the end-point potentiometrcally (2.2.20) I mL of 0.'M silver nitrate is equivalent to 5.844 mg of NaCl. ‘LABELLING The label states: . ~ where applicable, thatthe substance is suitable for use in the manufacture of parenteral preparations; ~ where applicable, that the substance is suitable for use in the ‘manufacture of peritoneal dialysis solutions, heemodialysis solutions or haemofiltration solutions. ¢ 0120170412 SODIUM CITRATE Natrii citras ings SCttig tm GHNe,0,2H,0 M2941 (6132-04-3] DEFINITION ‘Trisodium 2-hydroxypropane-1,2,3-tricarboxylate dihydrate. Content: 99.0 per cent to 101.0 percent (anhydrous substance), CHARACTERS Appearance: white or almost white, crystalline powder or white or almost white, granular crystals, slightly dliquescent ia moist air, Solubility: freely soluble in water, practically insoluble in ethanol (96 per cent) IDENTIFICATION A. To 1 mLof solution $ (sce Tests) add 4 mL. of water R. The solution gives the reaction of citrates (23.1). B. 1 mL of solution S gives reaction (e) of sodium (2.3.1). Tests Solution S. Dissolve 10.0 g in carbon dioxide free water R prepared from distilled water R and dilute to 100 ml. with the same solvent. Appearance of solution. Solution $ is clear (2.2.1) and ‘colourless (2.2.2, Method ID. Acidity or alkalinity. To 10 mL of solution $ add 0.1 mL of ‘phenolphthalein solution R. Not more than 0.2 mL. of 0.1.0 Iydrochlori acid or 0.1 M sodium hydroxide Is required to change the colour of the indicator Readily carbonisable substances. To 0.20 gof the powdered substance to be examined edd 10 ml, of sulfuric acid R and heat in a water-bath at 90 1°C for 60 min. Cool rapidly. ‘The solution is not more intensely coloured than reference solution Y, or GY, (2.2.2, Method IN. Chlorides (2.44): maximum 50 ppm. Dilute 10 mL. of solution $ to 15 mL with water R. Oxalates: maximum 300 ppm, Dissolve 0.50 gin 4 mL. of water R, add 3 mL of hydrochloric ‘cid R and 1 g of zinc R in granules and heat on a water-bath for 1 min, Allow to stand for 2 min, decant the liquid into ates-tube containing 0.25 ml. of a 10 g/l. solution ‘of phenylhydrazine hydrochloride R and heat to boiling. Cool rapidly, transfer to a graduated cylinder and add an equal volume of hydrochloric acid R and 0.25 ml. of potassium ferricyanide solution R. Shake and allow to stand for 30 min. ‘Any pink colour in the solution is not more intense than that in a standard prepared atthe same time in the same manner using 4 mL, of a 50 mg/L solution of oxalic acid R Sulfates (2.4.13): maximum 150 ppm. ‘To 10 ml of solution S add 2 ml of hydrochloric acid RI and dilute to 15 mL with distilled water R. Water (2.5.12): 110 per cent to 13.0 per cent, determined on 0.300 g. Use as the solvent a mixture of 20 ml. of methanol R, 30 ml of formamside R and 5 g of salicylic acid R. Pyrogens (268). If intended for use in the manufacture of large-volume parenteral prepsrations, the competent authority ‘may require that it comply withthe test for pyrogens. Inject per kilogram of the rabbits mass 10 mL ofa freshly prepared solution in water for injections R containing per milliitre 10.0 mg of the substance to be examined and 7.5 mg of, yrogen-free calcium chloride R. ASSAY Dissolve 0,150 gin 20 ml of anhydrous acetic acid R, heating, to about 50 °C. Allow to cool. Titrate with 0.1 M perchloric ‘acid, using 0.25 mL of naphtholbenzein solution R as indicator until a green colour is obtained. ‘ml of 0.1 M perchloric acid is equivalent to 8.602. mg of C.H.Ne,0,, STORAGE In an airtight container, SODIUM CROMOGLICATE 01/2017:0562 Natrii cromoglicas OOO fe" CH,Na,0, M, 512.3, (15826.37-6) DEFINITION Disodium 5,5-(2-bydroxypropane-1.3-diyi)aioxy)bis(4-ex0- AUC T-benzopyran-2-carboryat)- Content: 98.0 percent to 101.0 percent (tied substance). CHARACTERS Appearance: white or almost white, hygroscopic, crystalline powder Solubility: soluble in water, practically insoluble in ethanol. (Gs per ce). IDENTIFICATION First identification: B, D. Second tdentfcation: A, CD. A. Ultraviolet and visible absorption spectrophotometry (2.2.25). Test solution, Dissolve 10.0 mg in phosphate bufer solution pH 7.4 Rand diate to 100.0 ml. with tre same buffer folution, Dilute 10.0 mL ofthis solution to 1000 mi with Phosphate bufer solution pH 74 8 Spectral range: 230-350 am. “Absorption maxima: a 239 am and 327 nm. ‘General Notices (1) apply to all monographs and other texts 3813