centrifuge a portion of the mixture Dilute an accurately measured portion of The clear supernatant liquid quantitatively to obtain a solution contain

obtained with solution (1) is not more intense than trie spot in the chromato gram obtained with solution (2) and not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3J Uniformrty of content. Comply with the requirements stated under Tablets using the following method of analysis Powder one tablet and transfer to a 100-m1 volumetnc flask, add 60 ml of 0.1M hydrochlonc acid, and shake by mechanical means for 30 minutes. Dilute with 0 01 M hydrochlonc acid to volume, mix. and centrifuge a portion of the mixture Dilute an accurately measured portion of The clear supernatant liquid quantitatively to obtain a solution containing about 10 ug of amiloride hydrochlonde per ml. Measure the absorbance of the resulting solution at about 363 nm, Appendix 5 5 Calculate the content of C6 H8 CIN7 O takang 692 as the value of A(l %. 1 cm) at trie maximum at about 363 run. Other requirements Comphy with me requirements of tests staled under Tablets Assay Weigh and finefy powder 20 tablets Weigh accuratey a quantity of the powder equivalent to 10 mg of anhydrous amiloride hydrochlonde, transfer to a 100-m1 volumetric flask add 60 ml of 0 1M hyorochloric acid and complete the procedure described under Unrformity of content beginning at the words "and shake by mechanical means Calculate the content of C6 H8 CIN7 O, HCI taking 692 as the value of A(1 %, 1 cm) at the maximum at about 363 nmAMINOCAPROiC ACID NH2 CH2 CH2 CH2 CH2 CH2 COOHC6 H13 NO2 Mol Wt 131.17 Aminocaproic Acid rs B-ampnohexanoic acid Category Haemostatic; antifibnnolytic Dose Oralty and by slow intravenous infusion, initially 5 g followed by 1 to 1 25 g every hour until bleeding is under control, not more than 30 g per 24-hour period Description Colourless crystals or white, crystalline powder Solubility Freely soluble in water; slightly soluble in ethanol (95%) and in methanol, practically insoluble in chloroform and in ether It is soluble in acids and in alkalis.Storage Store in Dghtly-ctosed containers STANDARDSAminocaproic Acrd contains not less than 98 5 per cent and not more than 101 0 per cent of C6 H13 NO2 calculated with reference to the dried substance identification A. The infra-red absorption spectrum. Appendix 5.4. is concordant with the reference spectrum of aminocaproic acti or with the spectrum obtained from aminocaproic acid RS.B Carry out the method for thin-layer chromatagraphy. Appendix A 6, using silica gel G as the coating substance and a mixture of 25 volumes of ethanol (95%), 3 volumes, of water and 4 volumes of strong ammonia solution as the mobile phase Apply separately to the plate 2 ul of each of two solutions in water containing (1) 0 25% w/v of the substance being examined and {1} 0 25% w/v of ammocaproic acid RS After removal of the plate, spray it with a 0.25% w/v solution of ninhyonn in a mixture of equal volumes of methanol and pyndine and heat at I05a for 2 minutes. The principal spot in The chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).C. Melts at about 204* with decomposition. Appendix 0 8 pH Between 7 5 and G 0. determined in a 20 D% wtv solution.. Appendix 9 ll.Clanty and colour of solution A 20 0% w/v solution remains clear for 24 hours. Appendix G 1. and is colourless, Appendix 6 2 Stability Place 30 0 g evenly spread in a shallow dish about 9 cm in diameter, cover and allow to stand at 100* ±20 for 72 hours. Dissolves sufficient water to produce 100.0 ml Prepare a 200% wfa solution of Trie substance being examined but without the above treatment. Measure the absortances of trie two solutions at about 287 nm and at about 450 nm Afcsortiance of both solutions at about 287 nm is not more than 0 15 and at about 450 nm is not more than 0.03, Appendix 5.5 Heavy metals Not more than 10 ppm, determined on 1.0 g by MethodB. Appendix 3,12 Suiphated ash: Not more than 0.1 %, Appendix 3.22.Loss on drying Not more than 0.5%, determined on 1 g by drying in an oven at 105°. Appendix 8.6 Assay Weigh accurately about 0.2 g. dissolve in about 100 ml of anhydrous glacial acebc acid with gentle heat to effect solution, cool and carry out Method B for non-aqueous tilration. Appendix 3.45, using crystal violet 'solution as indicator Perform a blank determination and make any necessary correction Each ml of 0.1M perchlonc acid is equivalent to 0.01312 g of C6 H13 NO2 iAMINOCAPRQIC ACID INJECTION Aminocaproic Acid Injection is a sterile solution of Aminocaproic Acifl in Water for Injection.Usual strength 400-mg per ml. STANDARDSAminocaproic Acid Injection contains not less than 92.5 per cent and not more than 1075 per cent of the staled amount of aminocaproic acid, CftH]3NO? Identification To a volume equivalent to 0.4 g of Ammocaproic Acid add 1 ml of ether, stir, add 2 ml of