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Friday, July 3, 2009

Separate the precipitate by filtration and reserve the filtrate for test. E. Wash the precipitate with successive small

methanol, stir again and allow to stand: the crystals after drying on a water-bath comply wrth tests A and B descnbed under Aminocaproic Acid pH: Between 6.0 and 7.8, Appendix 8.11. Pyrogens Compiles with the test for pyrogens. Appendix 2.6. using 3 quantity containing not less than 0 3 g of Aminocaproic Acid per kg of the rabbits weight diluted with water for injection to produce a solution containing 10% w/v of Aminocaproic Acid Other requirements Complies with tne requirements of tests stated under Injectabie Preparations (Injections) As say: To a volume equivalent to 0 2 g of Aminocaproic Acid add 10 ml of ethanol and evaporate to dryness on a water-bath Dissolve the residue in 100 ml of anhydrous glacial acetic acid by gentle heating, if necessary, and complete the Assay descnbed under Aminocaproic Acid beginning at the words "and carry out Method B....." Each ml of 0. 1M perchloric acid is equivalent to 0.01312 g of C0 H13 NO2 AMlNOCAPROIC ACID TABLETS Usual Strength 500 mg Storage: Store in tighntly-closed containers. STANDARDSAminocaproic Acid Tablets contain not less than 95 0 per cent and not more than 1050 per cent of the slated amount of aminocaproic acid. C6 H13 NO2 identification Triturate. 2 tablets with 10 ml of water and filter into 100 ml of acetone. Swirl The mixture and allow to stand for 15 minutes to completa crystallisation. Filter through a medium porosity, sintered-glass filter and wash the crystals with 25 ml of acetone. Apply vacuum to remove the solvent, dry at 105" for 30 minutes and cool. The residue complies with tests A and B descnbed under Aminocaproic Acid. Other requirements. Comply with the requirements of tests stated under Tablets Assay Weigh and powder 20 tablets Weigh accurately a quantity of the powder, equivalent to 0.2 g of Aminocaproic Acid, add about 100 ml of anhydrous glacial acetic acid, heat gently to effect solution, cool and complete the Assay descnbed under Aminocaproic Acid beginning at the words "and carry out Method B Each ml of 0.1 M perchloric acid fs equivalent to 0.01312 g of C6 H13N02 .AMINOPHVLLINE Theophylline and Ethylenediamie (C7HBN4O2,C2H8N2 Mol. Wt. 42043 (anhydrous) Aminophylline is a stable mixture or combination of theophylline and ethylenedtamine. It may be anhydrous or may contain not more than two molecules of water of hydration Category Bronchodilator.Dose; Orally. 100 to 300 mg, by slow intravenous injecbon, 250 to 500 mg.Description; White or slightly yellowish granules or powder, odour, slightly ammoniacal On exposure to air it gradually loses ethylenediamine and absorbs carbon dioxide with liberation of free theophylline. Even in the absence of light it is gradually decomposed on exposure to a humid environment, the degradation being faster at higher temperatures .Solubility; Freely soluble in water (the solution usually becomes turbid on standing), practically insoluble in ethano! and in ether.Storage; Store in tightly-closed, light-resistant containers and protect from atmospheric carbon dioxide. STANDARDSAminophy Iline contains the equivalent of not less than 84.0 per cent and not more than 87.4 per cent of theophylline, C7He N4O2, and the equrvalent of not less than 13. 5 per cent and not more than 15.0 percent of ethylenediamine, C2 H8,N2 both calculated with reference to the anhydrous substance Identification Test A may be omitted if tests B, C, D and E are carmied out Tests B, C and D may be omitted if tests A and E are earned outA: Dissolve 1 g in 10 ml of water and add 2 ml of dilute hydrochloric acid dropwise, with shaking. Separate the precipitate by filtration and reserve the filtrate for test. E. Wash the precipitate with successive small quantities of cold water, recrystallise from hot water and dry at 100* to 105* The infra-red absorption spectrum. Appendix 5.4, of the crystalline powder is concordant with the reference spectrum of theophylline or with the spectrum obtained from theophyllie RS.B: The melting range of the dried crystalline powder obtained in test A is between 270* and 274*. Appendix B 8 C To 10 mg of the dried crystalline powder obtained in test A add 1 ml of hydrochlonc acid m a porcelain dish and 0.1 g of potassium chlorate and evaporate to dryness on a water-bath, invert the dish over a vessel containing a few drops of dilute ammonia solution, the residue acquires a purple colour Add a few drops of dilute sodium hydroxide solution, the colour is discharged D: Saturate in water a portion of the dried crystalline powder obtained in test A and add tannic acid solution, a precipitate soluble in excess of the reagent is produced. E: To the filtrate obtained in test A add 0.2 ml of benzoyl chfonde, make alkaline with 2M sodium hydroxide and shake vigorously Filter, wash the precipitate with 10 ml of water, dissolve in 5 ml of hot eihanol (95%) and add 5 ml of water. The melting range of the precipitate, after washing and drying at 100* to 105

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