Category Antibacterial Dose 2 to 6 g daily, in divided doses Description White, crystalline powder Solubility.

shaking, sufficient dimethylformamide to produce 100. 0 ml Dilute 10.0 ml to 100.0 ml with dimethylforrnamide and carry out the microbiological assay of antibiotics. Method A, Appendix 9. 1, and express the result in Units per mg.Amphotericin B intended for use in the manufacture Of mjectabte preparations complies with the following additional requirements Pyrogens; Complies with the test for pyragens. Appendix 2.6, injecting 0. 5 ml of a solution in water for injectton containing 2. 0 mg per ml per kg of the rabbit's weight, except that the sum of the responses of the group of three rabbits does not exceed 3 08*, the response of any individual rabbit does not exceed 1.1*. and the sum of the responses of eight rabbits, if the substance being examined does not pass the initial test with three rabbits, does not exceed 8.0* Sterility. Complies with the tests for sterility. Appendix 9 5, using 50 mg from each container AMPICILLIN Anhydrous AmpicillinAmpicillin is (6R)-6-(a-phenyl-D-glycylamino)penicillanic acid. Category Antibacterial Dose 2 to 6 g daily, in divided doses Description White, crystalline powder Solubility. Sparingly soluble in water; practically insoluble in ethanol, in chloroform, in ether and in fixed oils. It is soluble in dilute solutions of acids and of alkali hydroxides. Storage Store in tightly-closed containers in a cool, dry place. STAND ARDSAm picllim contains not less than 96.0 per cent and not more than 100.5 per cent of C 16 H 19 N3 O4 S, calculated with reference to the anhydrous substance Identification. Test A may be omitted if tests B and C are carried out Tests B and C may be omitted if test A is carried out .A; The infra-red absorption spectrum, Appendix 5. 4, is concordant with the reference spectrum of ampicilln or with the spectrum obtained from ampicillin RS.B; Carry out the method for thin-layer chromatography. Appendix 4.6. using srlanised silica gel H as the coating substance and a mixture of 90 volumes of a 15. 4% w/V solution of ammonium acetate and 10 volumes of acetone, the pH of which has been adjusted to 5.O 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 ampicillin RS and (3) 0. 25% w/v each of ampicillin RS and amoxytilln 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; Gives reaction B of penicillins and cephalosponns. Appendix 3 .1 pH Between 3 .5 and 5 .5, determined in a 0. 25% w/v solution, Appendix 8.11 Specific optical rotation. Between +230* and 305°, determined in a 0.25% w/v solution, Appendix 8.9 Clanty of solution. Dissolve 1 .0 g in 10 ml of IM hydrochloric acid and a further 1 .0 g in a mixture of 3 ml of dilute ammonia solution and 7 ml of water. Both solutions when freshly prepared are not more opalescent than opalescence standard OS2, Appendix 8 1 N,N-Dimethylaniline. Not more than 20 ppm, determined by the following method Carry out the method for gas chromatography, Appendix4 .2, using the following solutions. Dissolve 75 mg of N,N-diethylaniline (internal standard) in a mixture of 20 ml of hydrochloric acid and 20 ml of water and add sufficient water to produce 50 ml Dilute 2 ml of the resulting solution to 100 ml with water (solution A). Prepare a further solution in exactly the same way as solution A using 50 mg of N.N-dimethylaniline instead of the 75 mg of internal standard (sofution B) For solution 0) add 1 ml of solution A, 1 ml of dilute sodium hydroxide solution and 1 ml of cyclohexane to 1 ml of soluoon 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 3 ml of dilute sodium hydroxide solution, add 1 ml of cyclohexane, shake vigorously for 1 minute, centrifuge if necessary and, use the clear supernatant layer Solution (3) is prepared in exactly the same manner as solution (2) but using a mixture of 1 ml of solution A and 2 ml of dilute sodium hydroxide solution instead of 3 ml of dilute sodium hydroxide solution The chromatographic procedure may be carried out using (a) a glass column (1. 5 rnx4 mm) packed with 3% w/w of cyancethyf-silicone gum (XE-60 is suitable) on acid-washed, silanised diatomaceous earth (8O to 100 mesh) (Gas Chrom Q or Chromosorb W/AW/DMCS is suitable) maintained at a temperature of 80*. (b) a flame lanisatjon detector maintained at 150* and (c) nitrogen as the carrier gas with a flow rate of 30 ml per minute In the chromatogram obtained with solution (3). the ratio of The area of any peak due to N,dimethylaniline to the area of