Sodium hydrogen carbonate EUROPEAN PHARMACOPOEIA 10.0 = the intended use of the substances where applicable, thatthe substance is suitable for parenteral administration other than intra-articular administration; ~ wliere applicable, that the substance is suitable for parenteral administration, including intra-articular administrations ~ where applicable thatthe materials suitable for intra-ocular EJ SODIUM HYDROGEN CARBONATE Natrii hydrogenocarbonas 01/2017:0195 NaHCO, (144-55-8) DEFINITION Content: 99.0 per cent ta 101.0 percent, (CHARACTERS Appearance: white or almost white, crystalline powder. Solubility: soluble in water, practically insoluble in ethanol (96 per cent). ‘When heated in the dry state of in’solution, it gredully changes into sodium carbonate, IDENTIFICATION A. To 5 mal of solution S (see Tests) add 0.1 ml. of ‘phenolphthalein solution R. A pale pink colout is “Heat; gas is evolved and the calution becomes 3B. It gives the reaction of carbonates and bicarbonates (2.3.1). . Solution $ gives reaction (@) of sodium (2.3.1). ‘TESTS Solution S. Dissolve 5.0 j in 90 ml. of carbon dioxide-frée ‘water R and dilute to 100.0 ml. with the same solvent. Appearance of solution. Solution § is clear (2.2.1) and colourless (2.2.2, Method 11). Carbonates. The pH (2.2.3) of feshly prepared solution S isnot greater than 8.6. Chlorides (2.4.4): maximum 150 ppm. ‘To7 mL of solution S add 2'm of nitric acid R and dilute to 15 mL with water R. Sulfates (24.13): maximum 150 ppm. ‘To a suspension of 1.0 g in 10 ml of distilled water R add ydrochloric acid R until neutral and about 1 mL in excess. Dilute to 15 mL with distilled water R. Ammonium (2.4.1): maximum 20 ppm. Dilute 10 mL of solution $ to 15 ml. with water R, Prepare the standard using a mixture of 5 mL of water R and 10 mL of ‘ammonium standard solution (1 ppm NH) R. Arsenic (24.2, Method A): maximum 2 ppm, determined on 05g. Calcium (2.43): maximum 100 ppm. ‘To a suspension of 1.0 g in 10 mi of distilled water R add hydrochloric acid R until neutral and dilate to 15 mL. with distilled water R. Iron (24.9): maximum 20 ppm. Dissolve 0.5 g in 5 mL of dilute hydrochloric acid Rand dilute 0 10 mL with water R. duced. ASSAY Dissolve 0,750'g in 50 mL. of carbon dioxide-free water R, ‘Titrate with 1 M hydrochloric acid, determining the end-polat potentiometricaly (2.2.20), Read the volume added at the 2* point of inflection, or at the point of inflection if only 1 point is detected. 1 ml of 1 M hydrochloric actd is equivalent to 84.0 mg of NaHCO, Ks (01/2017:0677 SODIUM HYDROXIDE Natrii hydroxidum NOH [1310-73-2) DEFINITION Content: 97.0 per cent to 100.5 per cent. (CHARACTERS Appearance: white ot almost white, line masses, supplied as pellets, sticks or slabs, deliquescent, readily -sorbing carbon dioxide. Solubility: very soluble in water, freely soluble in ethanol (96 per cent), IDENTIFICATION A. pH 223): minimum 11.0, Dissolve 0.1 gin 10 mL of water R. Dilute t mL of the solution to 100 mL with water R. 3. Zl of soliton S (ee Text) gives reaction a) of dm (23. ‘TESTS Solution $. Carty out the procedire described below with caution. Dissolve 5.0 g in 12 ml. of water R. Add 17 mL of Iyedrochloric acid R, adjust to pH7 with a 103 g/L solution of Iydrochloric acid R and dilute to 50 ml with water R. Appearance of solution. The solution is clear (2.2.1) and colourless (22.2, Method 1. Dissolve 1.0 g in 10 mL of water R. Carbonates: maximum 2.0 per cent, calculated as Na,CO, as determined inthe asay Chlorides (24.4): maximum 200 ppm: Dissolve 0.25 g in 5 mL of water R, acidify the solution with about 4 ml of nitric acid R and dilute to 15 ml. with water R ‘The solution, without addition of dilute nitric acid R, complies with the test. Sulfates (2.4.13): maximum 200 ppm. Dissolve 6.75 g in 6 ml of distiled water R, adjust to pH.7 with Inydrochloric acid R and dilute to 15 ml. with distilled water R. Iron (24:9): maximum 10 ppm, determined on solution ASSAY Dissolve 2.000 gin about 80 ml. of carbon diaxide-fee water R ‘Add 03 ml of phenolphthalein solution Rand titrate with 1 M Iiydrochloric acid. Add 0.3 mL of methyl orange zlution Rand continue the titration with 1 M Iydrochlare acid 1 mL of 1M hydrochloric ald used in the 2" part ofthe titration is equivalent to 0.1060 g of Na,COs 1 mL of 1 M hydrochloric acid used in the combined titrations js equivalent to 40.00 mg of total alll calculated as NAOH. 3824 ‘See the information section on general mongeraohs (cover oaves)EUROPEAN PHARMACOPOEIA 10.0 Sodium lactate solution STORAGE ‘ian airtight, non-metallic container. 01/2017:0196 SODIUM IODIDE Natrii iodidum M1489 Appearance: white or almost white, crystalline powder or ‘loarless crystals, hygroscopic. “clublty: very soluble in water, frely soluble in ethanol [66 per cent) DDENTIFICATION Solution $ (see Tests) gives the reactions of iodides (23.1. Solution S. Dissolve 10.0 g in carbon dioxidefree water R prepred from distilled water R and dilute to 100 mi with the ne solvent. tlouless (2.2.2, Method ID). ‘To 125 mL of solution $ add 0.1 mL of Fromothymol blue solution RJ. Not more than 0.7 ml. of. LM hydrochloric acid is required to change the colour of fcindicetor. its, To 10 mL of solution $ add 0.25 ml of iodide-fee solution R and 0.2 ml of dilute sulfuric acid R and ‘to stand protected from light for 2 min. No blue colour ops. (2-413): maximum 150 ppm, ite 10 mi of solution Sto 15 ml with distilled water R sulfates. To 10 mL of solution $ add 0.1 ml. of starch rochloric acid R and titrate with 0.05 M potassium iodate the colour changes from red to yellow. Add 5 ml. of reform R and continue the titration, shaking vigorously, the chloroform layer is decolorised. 01201711151 SODIUM LACTATE SOLUTION. Natrii lactatis solutio DEFINITION Solution of @ mixture ofthe enantiomers of sodium 2-hydroxypropanoate in approximstely equal proportions. Content; minimum declared content 50 per cent m/m of sodium 2-hydroxypropanoate (C,H,NaO,; M, 112.1); 960 per ‘ent to 104.0 per cent of the conieht of sodiuin lactate stated on the label (CHARACTERS Appearance: clear, colourless, slightly syrupy liquid. Solubility: miscible with water and with ethanol (96 per cent). IDENTIFICATION ‘A. To 0.1 mL add 10 mL of water R.5 ml of the solution gives the reaction of lactates (2.3.1). 2B, It gives reaction (a) of sodium (2.3.1) ‘TESTS Solution S. Dilute a quantity of the substance to be examined corresponding to 40.0 g of sodium lactate to 200 ml. with distilled water R. Appearance of solution. TThe substance to be examined is. clear (2.2.1) and not more intensely coloured than reference solution BY, (2.22, Method I). pH (2.23):65 to 9.0 for the substance to be examined. Reducing suigars and sucrose. To 5 inl ofthe substance to be examined add 0.2 mL of copper sulfate solution R and 2-mL of dilute sodium hydroxide solution R. The solution is clear and ‘biue and remains so on boiling. Add to the hot solution 4 ml. of hydrochloric acid R. Boil for 1 min. Add 6 ml. of strong sodium hydroxide solution R and heat to boiling again. The solution is clear and blue ‘Methanol. Gas chromatography (2424). Limit: — methanol: maximum 50 ppm, calculated with reference to sodium lactate, if intended for use in the manufacture of parenteral preparations dialysis, heemodialysis or hacmofiltration solutions. Chlorides (2.4.4): maximum 50 ppm calculated with reference to sodium lactate. Dilute § ml of solution Sto 15 ml. with water R. The solution, complies with the test for chlorides. Oxalates and phosphates. To 1 mL of the substance to be examined add 15 mL of ethanol (96 percent) R and 2 ml of ealeium chloride solution R. Heat at 75 °C for 5 min. Any opalescence in the solution is not more intense than that of @ Standard prepared atthe same time and in the same manner using a mixture of 1 mL of the substance to be examined, 15 ml of ethanol (96 er cent) Rand 2 ml. of water R. Sulfates (2.4.13): maximum 100 ppm ealculated with reference to sodium lactate. ‘To 7.5 mL of solution S, add 1.9 mL. of hydrochloric acid RI and dilute to 15 ml. with distiled water R. The sotution complies with the test fr sulfates without addition of 0.5 mL of acetic ac R. Aciify the standard solution with 0.05 mL of hydrochloric acid RI instead of 0.5 mi of acetic acid R. Trl Notices (1) apply to all monographs and other tex