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EUROPEAN PHARMACOPOEIA 5.

Sodium carbonate monohydrate

ASSAY Dissolve 2.000 g in 25 ml of water R. Titrate with 1 M ASSAY hydrochloric acid, using 0.2 ml of methyl orange solution R as indicator. Dissolve 1.000 g in 25 ml of water R. Add 0.2 ml of methyl orange solution R as indicator. Titrate with 1 M hydrochloric 1 ml of 1 M hydrochloric acid is equivalent to 52.99 mg of acid until the colour changes from yellow to red. Na2CO3. 1 ml of 1 M hydrochloric acid is equivalent to 52.99 mg of STORAGE Na2CO3. Store in an airtight container. STORAGE Store in an airtight container. 01/2005:0192 01/2005:0191

Appearance of solution. Dissolve 2.0 g in 10 ml of water R. The solution is clear (2.2.1) and not more intensely coloured than reference solution Y6 (2.2.2, Method I). Alkali hydroxides and bicarbonates. Dissolve 0.4 g in 20 ml of water R. Add 20 ml of barium chloride solution R1 and filter. To 10 ml of the filtrate add 0.1 ml of phenolphthalein solution R. The solution does not become red. Boil the remainder of the filtrate for 2 min. The solution remains clear (2.2.1). Chlorides (2.4.4). Dissolve 0.4 g in water R, add 4 ml of dilute nitric acid R and dilute to 15 ml with water R. The solution complies with the limit test for chlorides (125 ppm). Sulphates (2.4.13). 15 ml of solution S complies with the limit test for sulphates (250 ppm). Arsenic (2.4.2). 5 ml of solution S complies with limit test A for arsenic (5 ppm). Iron (2.4.9). Dilute 5 ml of solution S to 10 ml with water R. The solution complies with the limit test for iron (50 ppm). Heavy metals (2.4.8). 12 ml of solution S complies with limit test A for heavy metals (50 ppm). Prepare the standard using lead standard solution (2 ppm Pb) R. Loss on drying (2.2.32). Not more than 1.0 per cent, determined on 1.000 g by drying at 300 C.

Appearance of solution. Dissolve 4.0 g in 10 ml of water R. The solution is clear (2.2.1) and not more intensely coloured than reference solution Y6 (2.2.2, Method I). Alkali hydroxides and bicarbonates. Dissolve 1.0 g in 20 ml of water R add 20 ml of barium chloride solution R1 and filter. To 10 ml of the filtrate add 0.1 ml of phenolphthalein solution R. The solution does not become red. Heat the remainder of the filtrate to boiling for 2 min. The solution remains clear (2.2.1). Chlorides (2.4.4). Dissolve 1.0 g in water R, add 4 ml of dilute nitric acid R and dilute to 15 ml with water R. The solution complies with the limit test for chlorides (50 ppm). Sulphates (2.4.13). 15 ml of solution S complies with the limit test for sulphates (100 ppm). Arsenic (2.4.2). 5 ml of solution S complies with limit test A for arsenic (2 ppm). Heavy metals (2.4.8). 12 ml of solution S complies with limit test A for heavy metals (20 ppm). Prepare the standard using lead standard solution (2 ppm Pb) R. Iron (2.4.9). 5 ml of solution S diluted to 10 ml with water R complies with the limit test for iron (20 ppm).

SODIUM CARBONATE DECAHYDRATE Natrii carbonas decahydricus


Na2CO3,10H2O Mr 286.1 DEFINITION Sodium carbonate decahydrate contains not less than 36.7 per cent and not more than the equivalent of 40.0 per cent of Na2CO3. CHARACTERS A white, crystalline powder or colourless, transparent crystals, efflorescent, freely soluble in water, practically insoluble in alcohol. IDENTIFICATION A. Dissolve 1 g in water R and dilute to 10 ml with the same solvent. The solution is strongly alkaline (2.2.4). B. The solution prepared for identification test A gives the reaction of carbonates (2.3.1). C. The solution prepared for identification test A gives the reactions of sodium (2.3.1). TESTS Solution S. Dissolve 5.0 g in portions in a mixture of 5 ml of hydrochloric acid R and 25 ml of distilled water R. Heat the solution to boiling and cool. Add dilute sodium hydroxide solution R until the solution is neutral and dilute to 50 ml with distilled water R. General Notices (1) apply to all monographs and other texts

SODIUM CARBONATE MONOHYDRATE

Natrii carbonas monohydricus


Na2CO3,H2O Mr 124.0 DEFINITION Sodium carbonate monohydrate contains not less than 83.0 per cent and not more than the equivalent of 87.5 per cent of Na2CO3. CHARACTERS A white, crystalline powder or colourless crystals, freely soluble in water, practically insoluble in alcohol. IDENTIFICATION A. Dissolve 1 g in water R and dilute to 10 ml with the same solvent. The solution is strongly alkaline (2.2.4). B. The solution prepared for identification test A gives the reaction of carbonates (2.3.1). C. The solution prepared for identification test A gives the reactions of sodium (2.3.1). TESTS Solution S. Dissolve 2.0 g in portions in a mixture of 5 ml of hydrochloric acid R and 25 ml of distilled water R. Heat the solution to boiling and cool. Add dilute sodium hydroxide solution R until the solution is neutral and dilute to 50 ml with distilled water R. 2425

Sodium cetostearyl sulphate

EUROPEAN PHARMACOPOEIA 5.0

Appearance of solution. Dissolve 2.0 g in 10 ml of water R. The solution is clear (2.2.1) and not more intensely coloured than reference solution Y6 (2.2.2, Method I). Alkali hydroxides and bicarbonates. Dissolve 0.4 g in 20 ml of water R, add 20 ml of barium chloride solution R1 and filter. To 10 ml of the filtrate add 0.1 ml of phenolphthalein solution R. The solution does not become red. Heat the remainder of the filtrate to boiling for 2 min. The solution remains clear (2.2.1). Chlorides (2.4.4). Dissolve 0.4 g in water R, add 4 ml of dilute nitric acid R and dilute to 15 ml with water R. The solution complies with the limit test for chlorides (125 ppm). Sulphates (2.4.13). 15 ml of solution S complies with the limit test for sulphates (250 ppm). Arsenic (2.4.2). 5 ml of solution S complies with limit test A for arsenic (5 ppm). Heavy metals (2.4.8). 12 ml of solution S complies with limit test A for heavy metals (50 ppm). Prepare the standard using lead standard solution (2 ppm Pb) R. Iron (2.4.9). 5 ml of solution S diluted to 10 ml with water R complies with the limit test for iron (50 ppm). ASSAY Dissolve 1.000 g in 25 ml of water R. Titrate with 1 M hydrochloric acid, using 0.2 ml of methyl orange solution R as indicator. 1 ml of 1 M hydrochloric acid is equivalent to 52.99 mg of Na2CO3.

B.

C. D. E.

F.

Allow the plate to dry in air and spray with a 50 g/l solution of phosphomolybdic acid R in alcohol R. Heat at 120 C until the appearance of the spots (about 3 h). The principal spots in the chromatogram obtained with the test solution are similar in position and colour to the principal spots in the chromatogram obtained with the reference solution. Examine the chromatograms obtained in the assay. The retention times of the two principal peaks in the chromatogram obtained with test solution (c) are similar to those of the two principal peaks in the chromatogram obtained with the reference solution. Dissolve 0.1 g in 10 ml of water R and shake. A foam is formed. It gives a yellow colour to a non-luminous flame. To 0.1 ml of the solution prepared for identification test C add 0.1 ml of a 1 g/l solution of methylene blue R and 2 ml of dilute sulphuric acid R. Add 2 ml of methylene chloride R and shake. The methylene chloride layer has an intense blue colour. Mix about 10 mg with 10 ml of ethanol R. Heat to boiling on a water-bath, shaking frequently. Filter immediately and evaporate to dryness. Dissolve the residue in 7 ml of water R, add 3 ml of dilute hydrochloric acid R and evaporate the solution to half its volume. Allow to cool. Filter. To the filtrate add 1 ml of barium chloride solution R1. A white, crystalline precipitate is formed.

TESTS Acidity or alkalinity. Dissolve 0.5 g with heating in a mixture of 10 ml of water R and 15 ml of alcohol (90 per cent V/V) R. Add 0.1 ml of phenolphthalein solution R1. 01/2005:0847 The solution is colourless. Add 0.1 ml of 0.1 M sodium hydroxide. The solution is red. SODIUM CETOSTEARYL SULPHATE Sodium chloride and sodium sulphate. Not more than a total of 8.0 per cent. Natrii cetylo- et stearylosulfas. Sodium chloride. Dissolve 5.00 g in 50 ml of water R, add dilute nitric acid R dropwise until the solution is neutral DEFINITION to blue litmus paper R. Add 2 ml of potassium chromate Sodium cetostearyl sulphate is a mixture of sodium cetyl solution R and titrate with 0.1 M silver nitrate. sulphate (C16H33NaO4S ; Mr 344.5) and sodium stearyl 1 ml of 0.1 M silver nitrate is equivalent to 5.844 mg of NaCl. sulphate (C18H37NaO4S ; Mr 372.5). It contains not less than Sodium sulphate. Dissolve 0.500 g in 20 ml of water R, 90.0 per cent of sodium cetostearyl sulphate and not less warming gently if necessary, and add 1 ml of a 0.5 g/l than 40.0 per cent of sodium cetyl sulphate, both contents solution of dithizone R in acetone R. If the solution is red, calculated with reference to the anhydrous substance. A add 1 M nitric acid, dropwise, until a bluish-green colour is suitable buffer may be added. obtained. Add 2.0 ml of dichloroacetic acid solution R and CHARACTERS 80 ml of acetone R. Titrate with 0.01 M lead nitrate until a persistent orange-red colour is obtained. A white or pale yellow, amorphous or crystalline powder, soluble in hot water giving an opalescent solution, practically 1 ml of 0.01 M lead nitrate is equivalent to 1.420 mg of insoluble in cold water, partly soluble in alcohol. Na2SO4. IDENTIFICATION Free cetostearyl alcohol. Not more than 4.0 per cent. Examine the chromatogram obtained with test solution (a) First identification : B, D, F. in the assay. Second identification : A, C, D, E, F. Calculate the percentage content of free cetostearyl alcohol A. Examine by thin-layer chromatography (2.2.27), using a in the substance to be examined, using the expression : TLC silanised silica gel plate R. Test solution. Dissolve 50 mg of the substance to be examined in 10 ml of alcohol (70 per cent V/V) R, heating on a water-bath. Reference solution. Dissolve 50 mg of sodium cetostearyl S = sum of the areas of the peaks corresponding sulphate CRS in 10 ml of alcohol (70 per cent V/V) R, to cetyl alcohol and stearyl alcohol in the heating on a water-bath. chromatogram obtained with test solution (a), Apply to the plate 2 l of each solution. Develop over a = mass of the internal standard added in the path of 12 cm using a mixture of 20 volumes of water R, mH preparation of test solution (a), in milligrams, 40 volumes of acetone R and 40 volumes of methanol R. STORAGE Store in an airtight container. 2426 See the information section on general monographs (cover pages)

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