Category: Ulcer-healing drug in gastric ulcer. Dose: 300 mg daily, in divided doses for 1 week; subsequently, upto 150 mg daily, in divided doses. Des

described under Carbenicillin Sodium using the mixed contents of 10 containers CARBENOXOLONE SODIUM C34H48Na2O7, Mol. Wt. 614.70 Carbenoxolone Sodium is disodium 3 - (3-carboxyl-atopropionyloxy)-! 1-oxo-olean-l2-en-30-oate. Category: Ulcer-healing drug in gastric ulcer. Dose: 300 mg daily, in divided doses for 1 week; subsequently, upto 150 mg daily, in divided doses. Description: White or pale cream powder; hygroscopic; irritant to nasal membranes.Solubility: Freely soluble in water; soluble in ethanol (95%); practically insoluble in chloroform and in ether. Storage: Store in well-closed containers STANDARDSCarbenoxolone Sodium contains not less than 97.0 per cent and not more than 103. 0 per cent of C34H48Na2O7, calculated with reference to the anhydrous substance. Identification: A: Dissolve 0.1 g in 5 ml of water, just acidify with 2M hydrochloric acid, stir well and filter. 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 5.4, of the residue is concordant with the reference spectrum of carbenoxolone or with the spectrum obtained from carbenoxolone sodium RS treated in the same manner. B: The light absorption in the range 230 to 360 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 256 nm,; absorbance at about 256 rim, about 0.5, Appendix 5.5. C: Mix 5 mg with 50 mg of resorcinol and 2 ml of sulphuric acid (80%) Heat at 200° for 10 minutes, cool, pour into 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 in a 1,0% w/v 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 0. 02M sodium carbonate, Appendix 8.9. Related substances Carry out the method for thin-layer chromatography. Appendix 4.6, using silica gel F2S4 as the coating substance (precoated Merck silica gel 60 F254 plates 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 µl 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 in sulphuric acid (60%) and heat at 105° for 10 to 15 minutes. By both methods of visualisation, any secondaryspot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2). Water: Not more than 40% w/w, determined on 06 g. Appendix 324 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 of 2