CzhfeMjAMllNOPIHYLLINE INJECTION Theophyliine and Ethyl enedia mine Injection Aminophylline Injection is a sterile solution

is between Appendix 8.8l Heavy metals Not more than 20 ppm. determined by Method A on a 8% w/v solution, Appendix 3 12 Related substances Carry out the method for thin-layer chromatography. Appendix 4. 6. using silica gel GF254 as the coating substance and a mixture of 40 volumes of 1-butanol. 30 volumes of acetone. 30 volumes of chloroform and 10 volumes of strong ammonia solution as the mobile phase Apply separately to tfie plate 10 ul of each of the following solutions For solution £1} dissolve 02g of the sub stance being examined in 2 ml of water with the aid of heat and dilute to 1 0 ml with meffianol For solution (2) dilute 1 volume of solution (I) to 200 volumes with methanol After removal of the plate, allow it to dry in air and examine under ultra-violet light (254 nm). Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) Suiphated ash; Not more than 0. 1 %. Appendix 3 22 Water Not more than 1 5% w/W (for anhydrous), determined on 2 g dissolved in 20 ml of pyndine Between 3 0 and 80% w/w (for hydrate), determined on 0 5 g, Appendix 3 24 Assay For theophyliine - Weigh accurately about 0 25 g. add 50 ml of water and 8 ml of dilute ammonia solution and warm gently on a water-bath until complete solution is effected Add 20.0 ml of 0 .1 M silver nitrate, mix and boil for 15 minutes. Cool to between 5* and 10 for 20 minutes, filler at a pressure not exceeding 2. 75 kPa and wash the precipitate with three quantities, each of 10 ml, of water Acidify the combined filtrate and washings with nitric acid and add an excess of 3 ml of the acid. Coof, add 2 ml of ferric ammonium sulphate solution, and titrate with 0 1M ammonium thiocyanate Each ml of 0. 1M silver nitrate is equivalent to 0.01802 g Of C7H8N4O2 .For ethylenediamine - Weigh accurately about 0 25 q and dissolve in 30 ml of water Titrate with 0.3M hydrochfonc acid using methyl orange solution as indicator Each ml of 0 1M hydrochtonc acid is equivalent to D003005 g of CzhfeMjAMllNOPIHYLLINE INJECTION Theophyliine and Ethyl enedia mine Injection Aminophylline Injection is a sterile solution of Aminopnylhne in Water for Injection or is a sterile solution of Theophylline in a solution of Ethylenediamme Hydrate in Water far Injection free from carbon dioxjde Aminophylhne Injection may contain an excess of ethylenediamine but no other substance maybe added Usual strengths. 250 mg in 10 ml; 500 rng in 2 ml Storage Store in single dose containers, from which carbon dioxide has been excluded Contact with metals should not be allowed Labelling. The label states (1) the strength in terms of the equivalent amount of anhydrous aminophyllme in a suitable dose-volume, (2) the route of injection, (3) that the injection is not to be