Mm 5 mg with 60 mg of resorcinol and 2 ml of Sulphuric acid [80%) Heat at 200* for 10 minutes.

following requiremants. Description While or almost while powder, odourless, hygroscopic. Identification; pH. Specific optical rotation; Iodine absorbing substances; Water; Pyrogens Comply with the requirements slated under Carbenicillin Sodium. Assay Carry out the Assay described under Carbenicillin Sodium using the mixed contents of 10 containers. CARBEN0X0LONE SODIUMC34H48Na2Q7, Wt 614.70 Carbenoxolone Sodium is disodium 3B-(3-carboxyl-atopropionyloxy)-11-oxo-olean-l2-en-30-Oate. Category Ulcer-healing drug in gastric ulcer Dose 300 nig daily, in divided doses for 1 week, subsequently, uplo 150 mg daily, in divided doses Description White or pale cream powder, hygroscopic, irritant to nasal membranes.Solubility Freely soluble in water, soluble in elhanol (95%), practically insoluble in chloroform and in ether Storage Store in well-closed containers STANDARDSCarbenonolone Sodium contains nol less than 97.0 per cent and not more than 103.0 per cent of C34H48Na2Q7L calculated with reference to the anhydrous substance. Identification A Dissolve 0.1 g in 5 ml of water, just acidify with 2M hydrochloric acidH stir well and filler Wash the residue with water until the washings are no longer acidic and dry to constant weight at 105° The infra-red absorption spectrum, Appendix S. 4, of the residue is concordant with the reference spectrum of carbenoxolone or with the spectrum obtained from carbenoxctone sodium RS Treaied in The same manner. B. The light absorption in the range 230 10 3EO nm of a 0.0025% w/v solution in a mixture of equal volumes of methanol and 0.02M sodium carbonate exhibits a maximum only at about 266 nm,h absorbance at about 256 nm, about 0.5, Appendix 5.5.C: Mm 5 mg with 60 mg of resorcinol and 2 ml of Sulphuric acid [80%) Heat at 200* for 10 minutes. Cool. pour mlu 200 ml of water and add sufficient 5M Sodium hydroxide to make the mixture just alkaline; an intense green fluorescence is produced D A 5% w/v solution gives the reactions of sodium salts, Appendix 3..1 pH Between 8.0 and 9.2. determined m a 1.0% Wv solution, Appendix 8.11.Specific optical rotation Between +132* To +140°. determined in a 1 % w/v solution in a mixture of equal volumes of methanol and Q 02M sodium carbonate, Appendix B 9 Related substances Carry out The method for thin-layer chromatography, Appendix A B. using silica gel F2S4 as the coating substance (precoated Merck silica gel GO F254 pi ales are suitable) and a mixture of 60 volumes of ethyl acetate, 20 volumes of methanol, 11 volumes of water and 1 volume of strong ammonia solution as the mobile phase Apply separately to the plate 5 ul of each of two solutions of the substance being examined in methanol containing (1) 1 50% w/v and (2) 0 030% w/v After removal of the plate, allow it to dry in air and examine under ultra-violet light (254 nm) Spray with a 1 5% w/v solution of vanillin m sulphunc acid (60%) and heat al 105* for 10 to 15 minutes. By both methods of visualisation, any secondaryspot in the chromalogram obtained with solution (1) is not more intense than the spot m the chromatograrm obtained with solution (2) Water Not more than 40% w/w, determined on 0.6 g. Appendix 3.24. Assay Weigh accurately about 1 g and dissolve in 30 ml of water. Add 30 ml of chloroform and 15 ml of a mixture of 10 volumes of 2M hydrochloric acid and 90 volumes of water, shake and allow to separate Add the chloroform layer to 40 ml of a 20% w/v solution of sodium chloride, shake and allow to separate Repeat the extraction with four quantities, each of 15 ml. of chloroform, combine the chloroform extracts and add sufficient chloroform to produce 100.0 ml Evaporate 25.0 ml, dry the residue at 100° at a pressure of2 kPa, dissolve in 10 ml of dimethylfdrmamide and carry out Method 6 for non-aqueous trtration, Appendix 3.45, usmg 01M letrabutylammomum hydroxide as litrant and thymal blue solution as indicator. Perform a blank determination and make any necessary correction Each mf of 0. IM tetrabutylammonium hydroxide is equivalent lo 0 Q3J73 g of C34H48Na2Q7.CARBENQXQLQNE SODIUM TABLETSCarbenoxolone Tablets Usual strength 50 mg. Storage