identification Shake a quantity of the powdered tablets equivalent to 0 5 g of amoxycillin with 5ml of water far 5 minutes,

more than 120.0 per cent of the stated amount of amoxyciilin, C16H19N3O4S, identification Shake a quantity of the powdered tablets equivalent to 0 5 g of amoxycillin with 5ml of water far 5 minutes, filter, wash the residue first with ethanol 3nd then with ether and dry for 1 hour at a pressure not exceeding 0.7 kPa.The residue complies with tests A and C described under Amoxycilhn Tnhydrate Uniformity of dispersion" Comply with the test descnbed under Tablets.Other requirements Comply with the requirements of tests slated under Tablets Assay Wergh and powder 20 tablets. Weigh accurately a quantity of the powder equivalent to U 15 g of amoxycillin, add sufficient water to produce 5000 ml. shake for 30 minutes, fjlter and complete the Assay descnbed under Amaxyciiim Capsules beginning at the words To 100 ml of the filtrate " AMPHOTERICIN B AmphotencinAmphotencin B is a mi>lure consisting mainly of amphotencin B which is (3R.5R.8R,9R,I-1S.13R,15S. f6R,17S.19R.34S.35R.36Rb37Sj-19-(3-amino-3,6-dideoxy-£-U-mannopyranosylQxy)-16-carboxy-3, 5, 8. 9, 11, 13, 15, 35octa-hydro>y-34, 36-dimethyl-13bi7-epoxyoctatnaconta= 20,22,24.26,28,30,32-heptaen-37-olide and other antrfungai polyenes produced by me growth of certain strains of Sfreptomyces nodosus or by any other means Category. Antifungal Dose Orally, upto 200 mg every six hours; by slow intravenous injection, 250 ug per kg of body weight daily. increased to 1 ug per taj daity or 1 5 mg per kg on alternate days Description Yellow to orange powder, practically odourless Even in absence of light, it is gradually decomposed in a humid environment, degradation being faster at higher temperatures In solutions, it is inactivated in presence of light and at low pH values Solubility Soluble in dimethyl sulphoxide, slight soluble in dimethylformamide and in methanoL insoluble in benzene, in ethanol [95%], in ether and in water Storage Store in fegfitly-closed, light-resistant containers in a cold place Labelling The label states (1) the number of Units per mg, (2) whether the material is intended for use in the manufacture of intertable preparations STANDARDSAmphrjtencin B has a potency of not less than 750 Units per mg, calculated with reference to the dried substance Identification A. The infra-red absorption spectrum. Appendix 5 A, is concordant with the reference spectrum of amphotencin B or with the spectrum obtained from amphotencin B RS B Dissolve 25 mg in 5 ml of dimethyl sulphoxide, add sufficient metfianol to produce 50 ml, and dilute 2 ml to 200 ml with metnanol The light absorption of the resulting solution in the range 300 to 450 nm exhibits three maxima, at about 362 nm, 381 run, and 405 nm. Appendix 55 The ratio of the absorbance at the maximum at about 36? nm to the absorbance at the maximum at about 381 nm, 0 5 to 0.6, the ratio of the absorbance at the maximum at about 381 nm to the absorbance at the maximum at about 405 nm, about Q.S C To 1 ml of a 0 05% wfV solution in dimethyl suiphoxide add 5 ml of phosphoric acid to form a lower layer. 3 blue ring is immediately formed at the junction of the liquids Mix, the mixture becomes intensely blue Add 15 ml of water and mix. the solution becomes pale straw-coloured pH Between 6 0 and 8 0. determined in a 3 0% w/v suspension in water, for injectable use, between 3 5 and 6 0, Appendix 8 11 Tetraenes Not more than 15 0% ( for injectable use, not more than 10 0%), determined by the following method For solution (1) weigh accurately about 50 mg, dissolve in 5 ml of dimethyl sulphoxide. dilute to 50.0 ml with methanol and drfute 4 0 ml of the resulting solution to 50.0 ml with methanol Prepare solution (2) in a similar manner using 50mg of amphotencin B RS, accurately weighed, instead of the substance being examined For solution (3) dissolve 25 mg of nystatin Rs. accurately weighed, in 25 ml of dimethyl sulphoxide, dilute to 250.0 ml with methanol and dilute 40 ml to 50 0 ml with methanol Using as the blank a 0.8% v/vsolution of dimethyl sulphoxide in methanol, measure the aosorbances of solutions (1), (2) and (3) at the maxima at about 282 run and about 304 nm, Appendix 5.5 Calculate the A(1 %. l cm) for the substance being examined, amphotencin B RS and nystatin RS at both wavelengths and calculate the content of tetraenes from the expression F + 100[A2B1 -respectively N1 and N2 are the A(1%; 1 cm] of nysiatin RS at about 283 rimand304 nrn respectively, B1. and B2 are the A( 1%, 1 cm) of amphotencin B RS at about 282 and 304 nm respectively and F is the declared content of tetraenes in arnphotericin B RS Sulphated ash Not more than 3 0% (for injectabte use, not more than 0 5%), Appendix 3 22.Loss on drying not more than 5. 0%. determined on 1 g by drying at 60* at a pressure not exceeding 0.7 kPa, Appendix $ 6 Assay Weigh accurately about 60 mg. triturate with dimerhylformamide and add, with