Sunday, August 2, 2009

calcium phosphates, calculated as Ca3(P04)2 Identification: Complies with the tests described under Dibasic Calcium Phosphate. Acid-insoluble substanc

more than 100.5 per cent of calcium phosphates, calculated as Ca3(P04)2 Identification: Complies with the tests described under Dibasic Calcium Phosphate. Acid-insoluble substances. Not more than 0.3%, determined by the method described under Dibasic Calcium Phosphate. Water-soluble substances: Digest 2.0 g with 100ml of water for 30 minutes on a water-bath, cool, addsufficienl water to restore the original volume, stir well and filter. Evaporate 50 ml of the filtrate to dryness and dry the residue at 105° to constant weight (0.5%) Arsenic Dissolve 2.0 g in a mixture of 15 ml of brominated hydrochloric acid, add 45 ml of water and remove the excess of bromine with a few drops of stannous chloride solution AsT, the resulting solution complies with the limit test for arsenic, Appendix 3.9 (5 ppm) Heavy metals: Not more than 40 ppm, determined by Method A, Appendix 3.12, on 25 ml of the solution prepared in the following manner. Warm 1.0 g with 4 ml of dilute hydrochloric acid, add sufficient water to produce 50 ml and filter Iron: Dissolve 0.2 g in a mixture of 5 ml of water and 0.5 ml of iron free hydrochloric acid with the addition of 1 g of citric acid. Dilute the solution to 40 ml with water, the solution complies with the limit test for iron, Appendix 3.13 (200 ppm).Carbonate. Suspend 1 g in 10 ml of water and add 2 ml of hydrochloric acid, no effervescence is produced Chloride: Dissolve 0.5 g in 25 ml of water by the addition of 1 ml of nitric acid the solution compiles with the limit test for chlorides. Appendix 3.10 (500 ppm) Sulphate: Dissolve 100 mg in water with the aid of 3 ml of IM hydrochloric acid and dilute to 60 ml with water 15 rnl of the resulting solution complies with the limit test for sulphates, Appendix 3.15 (0.6%) Proteinous impurities; Heat 0.5 g gently in a dry test-tube, no change in colour is observed and no unpleasant odour is emitted. Loss on ignition" Not more than 8.0%, determined on 1 g by igniting at 800° for 30 minutes, Appendix 8.7 Water Not more than 2.5% w/w, determined on I g. Appendix 3.24 Assay. Weigh accurately about 1 g and dissolve in 10 ml of hydrochloric acid by heating on a water-bath, add 50 ml of water, cool and dilute to 250.0 ml with water. To 250 ml of the resulting solution add 30.0 mf of 0.05M disodium edetate, 10.0 ml of ammonia buffer pH 10.9 and 100 ml of water and titrate the excess of disodium edetate with 0.05M zinc chloride using mordant black 11 solution as indicator. Each ml of 0.5M disodium edetate is equivalent to 0.00517 g of Ca3(PO4)2 CAPSULESCapsules are solid dosage forms in which the drug or a mixture of drugs is enclosed in Hard Gelatin Capsule Shells, in soft, soluble shells of gelatin, or in hard or soft shells of any other suitable material, of various shapes and capacities. They usually contain a single dose of active ingredient(s) and are intended for oral administration. The consistency of soft shells may be adjusted by the addition of substances such as Glycerin and Sorbitol Excipients such as opaque tillers, anti -microbal preservatives, sweetening agents, flavouring agents and one or more colouring agents permitted under the Drugs and Cosmetic Rules. 1945 may be added Capsules may bear surface markings.The contents of capsules may be of solid, liquid or paste-like consistency. They consist of the medicament(s) with or without excipients such as vehicles, solvents, diluents, lubricants.

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