continue lo heal until the odour of hydrogen chloride is no longer delectable and dissolve the residue in 0.5 ml (if water Prepare

dryness on a water-bath, continue lo heal until the odour of hydrogen chloride is no longer delectable and dissolve the residue in 0.5 ml (if water Prepare solution (2) in the same manner, but using bucitracin zinc RS in place of the substance being examined. Place the plate in the tank so Thai it is not in contact with the mobile phase arid allow to stand for at teats 12 hours before development. After removal of the plate, allow it to dry at 105°. spray with eThanolic nmhydrm solution and heal a; 110* for 5 minutes. The bands in the chrtmialogram obtained with solution (1) correspond to those in the chromatograrrn obtained with solution (2) B. Shake 5 mg. with 1 ml of water, add 1 ml of a 0.2% w/v solution of ninhydnn in 1-bulanol and 0.5 ml of pyriine and heat at 100° for 5 minutes, a deep purple colour is produced pH Between 5.5 and 7.5 determined in a 1 %w/v solulion. Appendix 8.11 Clanly and colour of solution A 1 % w/v solution in carbon dioxide -free water is clear. Appendix 6.1 and not more intensely coloured than reference solution BYS6. Appendix 6.2 Bacitracin F and related substances; The ratio of the absorbance at about 290 nm to that at about 252 nm of a 0.03% w/v solution in 0.05M sulphuric acid is not more than 0.20. Appendix 5.5 Sulphated ash; Not more than 3.0%, Appendix 3.22 Loss on drying Nol more than 5.0% determined on 0.5 g by drying over phosphorus pentonide at GO*at a pressure not exceeding 0.1 kPa for 3 hours, Appendi* 8.6 Assay. Carry out the microbiological assay of antibiotics, Method A, Appendix 9.1. and express the results in Units per mg Bacilracm intended for use in the manufacture of ophthalnuc preparations complies with the following additional requirement Sterility Complies with the tests for sterility, Appendix 9.5. BACITRACIN ZIMCBacilracin Zinc is the zinc complex of Bacilracin Category Antibacterial (for topical use). Description: White or light yellowish-grey powder, odourless or with a faint odour, hygroscopic Solubility Slightly soluble in water and in elhanol (5-5%); very slightly soluble in ether; insoluble in chloroform Storage Store in tightly-closed containers in a cool, dry place If it is intended for administration as a spray in internal body cavities, the container should be sterile and sealed so as to exclude micro-Organisrns.Labelling The labet states (1) the number of Unrts per mg. (2.) whether or not contents are intended for administration as a spray m internal body cavities.STANDARDSBacitracm Zinc has a potency of nor less than BO Units of bacitracin activity per mg, calculated with reference to the dried substance Identification. A Com plies with the tests described under Bactracin B; ignite 0.15 g and allow to cool. The residue on dissolving in 1 ml of 2M hydrochloric acid and diluting with 4 rnl of water gives Ihe reactions of zinc salts. Appendix 3.1 pH Between 6.0 and 7.5. determined on the filtrate obtained by shaking 1 g with 10 ml of carbon dioxide-free water. Appendix 8 11 Bacitracin F and related substances The ratio of the absorbance at about 290 rim To that at about 252 rim of a0.03% w/v solution in 0.05M sulphunc acid is not more Than 0 15. Appendix 5.5.Zinc content. Between 40% and 8.0%, calculated with reference To The dried substance, determined by the following method Weigh accurately about 02 g and dissolve m 20 ml of water and 3 ml of strong ammonia-am mo mum chlonde solution and titrate with 0.01 M disodium edelate using mordant black 11 muxture as indicator. Each ml of 0.01M disodium edetale is equivalent to 0.000654 g of Zn Loss on drying Not more than 5.0%. determined on 0.5 g by drying over phosphorus pentotide at 60° at a pressure not exceeding 0.1 kPa for 3 hours. Appendix 8.6.Assay: Weigh accurately about 0.1 g. suspend in 10 ml of water and 0.5 ml of 2M hydrochloric acid and add sufficient water To produce 200.0 ml Allow lo stand at room temperature for 30 minutes and carry out the microbiological assay of antibiotics. Method A, Appendix 9.1, and express the results in Units per mg.Bacitracin Zinc intended for administration as a spray internal body cavities complies with the following additional requirements Pyrogens Complies with the lest for pyrogens, Appendix 2.6h using 1 ml par kg of the rabbit’s weight of the supernatant liquid obtained by centrifuging a suspension in saline solution containing 600 Units per nil Sterility. Complies with the tests