, practically insoluble in chloroform and in ether Storage.

equivalent of 1 to 3 g of amoxycillin daily, in divided doses Description White or almost white powder very hygroscopic Solubility Very soluble in water, sparingly soluble in ethanol, very shgiifiy soluble in acetone, practically insoluble in chloroform and in ether Storage. Store in tightly-closed containers in a cool, dry place If it ts intended for use in the manufacture of injectable preparations, the container should be sterile, tamper-evident and sealed so as to exclude micro-organisms Labelling. The label states whether or not the material is intended for use in the manufacture of injectable preparations. STANDAROSAmoxycillin Sodium contains not less than 85.0 per cent and not more than 100.5 per cent of C16H18N3NaO5S. calculated with reference to the anhydrous substance. The sum of the percentage contents of amoxycillin sodium, degradation products, calculated as C16H18N3NaO5S. 2-ethythexanoic acid and sodium chloride is not less than 95.0. calculated with reference to the anhydrous substance Identification Test A may be omitted if tests B, C and D are carried out. Tests B and C may be omitted t tests A and D are carried out. A The infra-red absorption spectrum. Appendix 5.4, is concordant with the reference spectrum af amoxycillin sodium or with the spectrum obtained from amoxycillin sodium RS.B. Carry out the method for thin-layer chromatography, Appendix- 4.6, using silanised silica gel H as the coating substance and a mixture of 90 volumes of a 15.4% w/v solution of ammonium acetale and to volumes of acetone, thep H of which has been adjusted to 5.0 witn glacial acetic acid, as the mobile phase Apply separately to the plate 1 ul of eacn of three solutions in 0.5M sodium bicarbonate containing (1)0.25% v/w of the substance being exammed, (2) 0 25% v/w of amoycillin trihydrate RS and (3) 0.25% w/v each of amoxycillin tnhydrate RS and ampicillin mhydrate RS After removal of the plate, allow it to dry in air, expose it to iodine vapour and examine The principal spot in the chramatogram obtained with solution. (1) corresponds to that in the chromatogram obtained with solution. (2) The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated principal spots C: Gives reaction B of penicillins and cephalosporins. Appendix 3 .1 D A 5% v/w solution gives the reactions of sodium salts. Appendix 3.1 pH Between 8.0 and 10.0, determined in a 10% w/v solution, Appendix 8.11 in Clarity and colour of solution. A 10% w/v solution is not more opalescent than opalescence standard OS2. Appendix 6.1. when examined immediately after preparation. The solution may initialty be having a pink colour and its absortance after 5 minutes at about 430 run is not more than 0.20, Appendix 6.2 Specific optical rotation Between +240* and +290*, determined in a 0 25% w/v solution in 0.02M potassium hydrogen phthalate. Appendix 8.9 Heavy metals Not more than 20 ppm, determined on 1. 0 g by Method B. Appendix 3.12 N,N- Dimethylaniline Not more than 20 ppm, determined by the following method Carry out the method for gas chromatography. Appendix 4.2. injecting 1 ul of each of the fallowing solutions Prepare a 0.005% w/v solution of naphthalene (internal standard) in cyclohexane (solution A) Mix 50 mg of N.N-dimetiyaniline with 2 ml of hydrochloric acid and 20 ml of water. dissolve by shaking, make up to 50 ml with water and dilute 5 ml of this solution to 250 ml with water (solution B) For solution
(1) mix 1 ml of solution A, 5 ml of dilute sodium hydroxide solution and 1 ml of solution B. shake vigorously for 1 minute, centrifuge if necessary and use the clear supernatant layer For solution (2) dissolve 1.0 g of the substance being examined in 5 ml of dilute sodium hydroxide solution, add 1 ml of cydohexane. shake vigorously for 1 minute, centrifuge if necessary and use the clear supernatant layer. Solution (3) is prepared in the same manner as solution
(2) but using 1 ml of solution A in place of cyclohexane. The chromatographic procedure may be earned out using (a) a glass column (2 m x 2 mm) packed with acid-washed silanised diatomaceous support (Gas Chrom O. BO-100 mesh s suitable) coated with 3% w/v phenyl methyl silicone fluid (50% phenyl) (CV-17 is suitable) and maintained at a temperature of 150*, (b) a flame ionisation detectorrnaintained at 150° and (c) a flow rate af 30 ml per minute of the carrier gas Sodium chloride Not more than 20%, calculated with reference to the anhydrous substance, determined by the following method Dissolve 1.0 g in 50 ml of distilled water, add 10 ml of 2 M nitric acid and titrate with 0.1M silver nitrate, determining the end-point patentiometrically using a silver indicator electrode and a mercury-mereurous sulphate reference electrode or any other suitable electrode. Each ml of 0.1 M silver nitrate is equivalent to 0.005845 g of NaCl Degradation products. Not more than 9.0%. determined by the following method