. Appendix 8 9 p-Alanine Carry out the melfiod tor thin-layer chromalography Appendix

minute, cool, and add 5 ml of 1 M hydrochloric acid and 2 drops of ferric chloride test solution; a strong yellow colour is produced. C: To 50 mg in 2 ml of 1M sodium hydroxide add 0.1 mi of copper sulphate solution, a blue colour Is produced.0 Gives reaction A of calcium salts. Appendix 3 1.pH Between 6 8 and 8 0, determined in a 5 0% w/v solution. Appendix . 8.11 Clarity and colour of solution A 5.0% w/v solution in carbon dioxide free water 13 clear. Appendix 6 1, and colourless, Appendix 6.2.Specific optical rotation Between +25 0° and +27 5°, determined al 20° In a 5% w/v solution. Appendix 8 9 p-Alanine Carry out the melfiod tor thin-layer chromalography Appendix 4.6. using silica gel G as the coaling substance and a mixture of 65 volumes of elhanol and 35 volumes of water as the mobile phase but allowing the solvent front to ascend 12cm above the line of application Apply separately to the plate 5 ul of each of four solutions in water containing (1) 40% w/v of the substance being examined, (2) 04% w/v of the substance being exanined. (3) 0.4% w/v of calcium pantolhenate RS and (4) 0.02% w/v of {$-alanine After removal of the plate, dry it in a current of air, spray with ethanolic ninhydrin solution and heal at 110* for 10 minutes Any spot corresponding to P-alanine In The chromatogram obtained with solution (1) is not more intense than the spot in the chromalogram obtained with solution (4). Heavy metals Not more than 20 ppm, determined by Method A on 1 0 g dissolved In 25 ml of water, Appendx 3.12 Loss on drying Not more than 3.0%, determined on 1 g by tfying in an oven at 105°, Appendix 8 6.Assay. Weigh accurately about 0.18 g, (dessolve in 50 ml of anhydrous glacial acetic acid and carry out Method A for non-aqueous iltration, Appendix 345, determining the endpolnl potenliometrically Perform a blank determination and make any necessary correction Each ml at 0,1M perchloric acid Is equivalent to CaHPO4, 2H2O Mol Wt 172.09 (dihydrate) Dibasic Calcium Phosphate is anhyAous or contains two molecules of water of hydratten Category Calcium supplement pharmaceutical aid (exclpienl) Dosa As cateiurn supplement, 1 to 5 g Description While, crystalline powder; odourless Solubility Practically insoluble In water and in elhanol (95%). It dssolves in dilute hydrochloric acid and in nitric acid. Storage Store in well-closed containers STAN DARDSDi basic Calcium Phosphate contains not less than 980 per cent and not more than 105.0 per cent of CaHPO4 (for anhydrous material) or of CaHPO4, 2H2O (for the dihydrate) Identification A: Grves reaction B or calcium salts. Appendix 3. 1.B Dissolive (). I g in a mixture of S ml of 2M nitric acid and S ml of water (lie solution gives reaction C of phosphates. Appendix 3.1 Acid-Insoluble substances Heat 5g with a mtxture ol 40 ml of water and 10 ml of hydrochlorlc acid and dilute to 100ml with water Filter, wash with hot water until the last washing is tree from chloride and dry the residue at 105° for 1 hour (0.1 %) Arsenic. Dissolve 1 0 g In 15 ml of brominated hydrochloric acid add 45 ml of water and remove the excess of bromine with a few (tops of stannous chloride solution AsT, the resulting solution complies with the limit test for arsenic. Appendx 3.9 (10. ppm) Heavy metals Not more than 40 ppm, determined by Method A, Appenobt 3.12, on 10 ml of a solution prepared in the fallowing manner Dissolve 2 5 g in 20 ml of 2M hydrochloric acid, filter if necessary, and add 6M