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Friday, July 3, 2009

. Measure the height (a) of the peak due to tertiary amine and the height (b) of the lowest part of the curve separating this peak

(c) a detection wavelength of about 226 tun. Inject 20 ul of solution (3). The test is not valid unless in the chromatogram obtained with solution (3) a peak due to 4-hydroxyphenylacetamide and 4--(2,3'dihydroxypropoxy)-phgnylacetamide (diol) elutes wrthpn 5 minutes of injection and peaks due to 4. 4-[N-rsopropyl-3,3-iminobis (2-hydfOxypropoxy) bis (phenylacetamide) (tertiary amine) and 4-(2-hydroxy-3-isopropylaminopiopoxy) phenytecetic acid (biocker acid) elute after the principal peak Adjust the sensitivity of the amplifier so that the peak due to tertiary amine in the chrcmatogram obtained with solution (3) is between 30% and 80% of full-scale deflection on [he charl paper. Measure the height (a) of the peak due to tertiary amine and the height (b) of the lowest part of the curve separating this peak from the principal peak. The test is not valid unless a is greater than 3b. linject separately 20 pi of each of solutions (1) and (2). In Ihe chrornalogram obtained with solution (1) the area of any secondary peak with a retention time greater than that of the peak due to 4-hyaraxyphenylacetamide and 4-(2,3 dihydroxypropcxy)phenytaceTamide in the chrornalogram obtained with solution (3) is not greater than the area ol the peak in the chrcmatogram obtained with solution (2) and Ihe sum of the areas of any such secondary peaks is not greater than 1. 5 times the area of the peak in the chfomatogram obtained with solution (2) Ignore any peak with a retention time greater than that of Ihe peak due to 4-(2-hydroxy3-isopropylammopropoxy)phenylacetic acid in the chromatogram obtained with solution (3) 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 Atenolol, transfer to a 500-m1 volumetric Mask using 300 ml of methanol, heat the resulting suspension to 60° and shake for 15 minutes. Cool, dilute to 500 0 ml- with rnethanol, fitter through a sintered-glass funnel (Porosil G3) and dilute a suitable volume of the filtrate with sufficient methanol to produce a solution containing 0.01% w/v of Atenolol. Measure the absorbance of the resulting solution at Ihe maximum at ahouf 275 run, Appendix 55 Calculate the content of C14 H22 N2 O3 taking 53.7 as the value of A(l%b 1 cm) at the maximum at about 275 runATRQPlNE METHOMTRATE Melhylatropme Nitrate Atrapine Melhonrtrate is (RS)-(1R,3r,5S)-8-methyl-3-tropoyloxytropanium nitrate Category: AntrehoIinergic Dose. In the treatment of congenital hypertrophic pyloric stenosis in infants. 200 to 6OO ug, half an hour before feeds. Description; Colourless crystals or white, crystalline powder Solubility Freely soluble in water; soluble in ethanol (95%). practically insoluble in chloroform and in ether. Storage: Store in well-closed, light-resistant containers. STANDARDSAtropine Methonitrate contains not less than 99.0 per cent and not more than 101.0 per cent of C18 H26 N2 O6 , calculated with reference to the dried substance. Identrfication Test A may be omitted if tests B, C.D and E are carried out. Tests B. C and D may be omitted if tests A and E are carried out A; The infra-red absorption spectrum. Appendix 5 4, is concordant with the reference specTrum of aTropme methomfrate or with the spectrum obtained from alropine malhonilrate RS.B; To 0 O5 ml of a 1 %w/v solution add 0.05 ml of aO.1% w/v solution ofdiphenylamine in nitrogen free sulphuric acidh an intense blue colour is produced.C: To 2.5 mf of a 10% w/v solution add 2.5 ml of water and 2 ml of dilute sodium hydroxide solution; no precipitate is produced D Add about 1 mg to 4 drops of fuming nitric acid and evaporate to dryness on a water-bath, a yellow residue is obtained. To the cooled residue add 2 ml of acetone and 4 drops of a 3% w/v solution of potassium hydroxide in methand, a violet colour is produced. E; Melts between 166° and 168° Appendix 8.8 pH: Between 6.0 and 7.5, determined in a 5.0% w/v solution. Appendix 8 11.Clarity and colour ol solution: A 5. 0% w/v solution in carbon dioxide tree water is clear. Appendix 6 1, and not more intensely coloured than reference solution BS8, Appendix 6.2-Specific optical rotation: Between -025° and +0.05°, determined in i 10% w/v solution, using a 2-dm tube, Appendix 8.9 (distinction from hyoscyamine). Silver. To 10 ml of a 10% w/v

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