If it is intended for use in the manufacture of injectable preparations

being examined and from the declared content of C16H19N3O4S in ampicillm trihydrate RS AMPICILLIN SQDIUMC16HlsN3NaO4S Mol. Wt. 371.39 Ampicillm Sodium is sodium (6R)-6-(a-phenyl-D-glycyl-ammo)penicillmate. Category: Antibacterial. Dose:. By intramuscular or intravenous injection, the equivalent of 1 to 3 g of ampicillm daily, in divided doses. Description: White, crystalline powder; hygroscopic. Solubility: Freely soluble in water; sparingly soluble in acetone; slightly soluble in chloroform; practically insoluble in ether, in liquid paraffin and in fixed oils. Storage. Store: in tightly-closed containers in a cool, dry place. If it is 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. STANDARDSAmpicillm Sodium contains not less than 92. 5 per cent and not more than 100.5 per cent of C16HlsN3NaG4S, calculated with reference to the anhydrous substance. The sum of the percentage contents of ampicillm sodium and degradationproducts, calculated as C16HlsN3NaG4S, is not less than 97. 5, 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 if tests A and D are carried out. A: The infra-red absorption spectrum, Appendix 5.4, is concordant with the reference spectrum of ampicillm sodium or with the spectrum obtained from ampicillm sodium RS. If the spectra are not concordant, prepare another spectrum by the following method To a solution of 0 .25 g in 5 ml of water add 0. 5 ml of 2 M acetic acid, swirl the mixture and a How to stand for 10 minutes in ice. Filter with suction through a smtered-glass filter (porosity No. 3), wash the residue with 2 to 3 ml of a mixture of 9 volumes of acetone and 1 volume of water, dry the residue at 60° for 30 minutes and prepare a new spectrum of the residue. The infra-red absorption spectrum of the residue, Appendix 5.4, is concordant with the reference spectrum of ampicillm trihydrate or with the spectrum obtained from ampicillm trihydrate 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 acetate and 1 0 volumes of acetone, the pH of which has been adjusted to 5. 0 with glacial acetic acid, as the mobile phase. Apply separately to the plate 1 ul of each of three solutions in a 4. 2% w/v solution of sodium bicarbonate containing (1) 0 .25% w/v of the substance being examined, (2) 0.25% w/v of ampicillm trihydrate RS and (3) 0.25% w/v each of ampicillm trihydrate RS and amoxycillm trihydrate RS. After removal of the plate, allow it to dry in air, expose it to iodine vapour and examine. The principal spot in the chromatogram 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: Complies with test C described under Ampicillm. D: A 5% w/v solution gives the reactions of sodium salts, Appendix 3. 1 .pH: Between 8: 9 and 10.0, determined 1 0 minutes after dissolution in a 10% w/v solution, Appendix 8.11. Clarity and colour of solution: A 10% w/v solution is clear, when examined immediately after preparation, Appendix 6.1, and the absorbance of the solution at about 430 nm is not more than 0.15, Appendix 5.5. Specific optical rotation: Between +253° and +237°, determined in a 0.25% w/v solution in 0.02M potassium hydrogen phthalate, Appendix 8.9. N,N. -Dimethylanilme: Complies with the test described under Ampicillm. Dichloromethane Not more than 0.2% w/w, determined in the following manner. Carry out the method for gas chromatography Appendix 4. 2; using the following solutions in water containing (1) 10% w/v of the substance being examined, (2) 10% w/v of the substance being examined and 0.02% v/v of 1,2- dichloroethane (internal standard) and (3) 0. 02% v/v of dichloromethane and 0.02% v/v of internal standard. The chromatographic procedure may be carried out using (a) a glass column (1.5 m x 5 mm) packed with acid washed, silanised diatomaceous support (100 to 120 mesh) coated with 1 0% w/w of polyethylene glycol 1000 and maintained at 60° with inlet port temperature at 100°, (b) a flame lonisation detector with detector temperature maintained at 150°, and (c) nitrogen as the carrier gas with 40 ml per minute as the flow rate. Calculate the percentage w/w of dichloromethane, assuming its weight per ml at 20 to be 1.325 g, Appendix 8.15. Heavy metals: Not more than 20 ppm, determined on 1.0,g by Method B, Appendix 3.12. Water: Not more than 2.0% w/w, determined on 0.3 g, Appendix 3.24 Assay: Weigh accurately about 50 mg,