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【求助】英国药典阿奇霉素质量标准 已有6人参与
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jinyixiao
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3楼2010-04-15 22:56:51
jinyixiao
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ccmaodou(金币+1):谢谢参与
ccmaodou(金币+20):十分感谢！ 2010-04-16 08:17
ccmaodou(金币+1):谢谢参与
ccmaodou(金币+20):十分感谢！ 2010-04-16 08:17
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(Ph Eur monograph 1649) [bitmap] C38H72N2O12 749 83905-01-5 Action and use Antibacterial. Ph Eur DEFINITION (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-a-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-b-D-xylo-hexopyranosyl]oxy]-1-oxa-6- azacyclopentadecan-15-one. Content 94.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white powder. Solubility Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride. IDENTIFICATION A. Infrared absorption spectrophotometry (2.2.24). Comparison azithromycin CRS. If the spectra obtained in the solid state show differences, prepare further spectra using 90 g/l solutions in methylene chloride R. B. Examine the chromatograms obtained in the assay. Results The principal peak in the chromatogram obtained with test solution (b) is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (a). TESTS Solution S Dissolve 0.500 g in anhydrous ethanol R and dilute to 50.0 ml with the same solvent. Appearance of solution Solution S is clear (2.2.1) and colourless (2.2.2, Method II). pH (2.2.3) 9.0 to 11.0. Dissolve 0.100 g in 25.0 ml of methanol R and dilute to 50.0 ml with carbon dioxide-free water R. Specific optical rotation (2.2.7) - 45 to - 49 (anhydrous substance), determined on solution S. Related substances Liquid chromatography (2.2.29). Prepare the solutions immediately before use. Solvent mixture acetonitrile R, water R (40:60 V/V). Test solution (a) Dissolve 0.100 g of the substance to be examined in the solvent mixture and dilute to 25.0 ml with the solvent mixture. Test solution (b) Dilute 5.0 ml of test solution (a) to 20.0 ml with the solvent mixture. Reference solution (a) Dissolve 50.0 mg of azithromycin CRS in the solvent mixture and dilute to 50.0 ml with the solvent mixture. Reference solution (b) Dilute 1.0 ml of test solution (a) to 100.0 ml with the solvent mixture. Reference solution (c) Dissolve 5.0 mg of azithromycin CRS and 5.0 mg of azithromycin impurity A CRS in the solvent mixture and dilute to 50 ml with the solvent mixture. Reference solution (d) Dissolve the contents of a vial of azithromycin impurity B CRS in 1.0 ml of the solvent mixture. Use this solution for identification of the peak due to impurity B. Column: —size: l = 0.25 m, Ø = 4.6 mm, —stationary phase: end-capped polar-embedded octadecylsilyl amorphous organosilica polymer R (5 µm), —temperature: 70 °C. Mobile phase Mix 10 volumes of a 34.84 g/l solution of dipotassium hydrogen phosphate R previously adjusted to pH 6.5 with phosphoric acid R, 35 volumes of acetonitrile R and 55 volumes of water R. Flow rate 1.0 ml/min. Detection Spectrophotometer at 215 nm. Injection 100 µl of test solution (a) and reference solutions (b), (c) and (d). Run time 4.5 times the retention time of azithromycin. Relative retention With reference to azithromycin (retention time = about 26 min): impurity D = about 0.37; impurity J = about 0.39; impurity A = about 0.42; impurity I = about 0.5; impurity C = about 0.65; impurity K = about 0.9; impurity F = about 1.6; impurity B = about 1.7; impurity G = about 2.8. System suitability Reference solution (c): —resolution: minimum 7.0 between the peaks due to impurity A and azithromycin. Limits: —impurity B: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent), —any other impurity: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent), —total: not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (5.0 per cent), —disregard limit: 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.1 per cent). Heavy metals (2.4.8) Maximum 25 ppm. Dissolve 2.0 g in a mixture of 15 volumes of water R and 85 volumes of anhydrous ethanol R and dilute to 20 ml with the same mixture of solvents. 12 ml of the solution complies with test B. Prepare the reference solution using lead standard solution (2.5 ppm Pb) obtained by diluting lead standard solution (100 ppm Pb) R with a mixture of 15 volumes of water R and 85 volumes of anhydrous ethanol R. Water (2.5.12) 1.8 per cent to 6.5 per cent, determined on 0.200 g. Sulphated ash (2.4.14) Maximum 0.2 per cent, determined on 1.0 g. ASSAY Liquid chromatography (2.2.29) as described in the test for related substances, with the following modification. Injection 25 µl of test solution (b) and reference solution (a). Calculate the percentage content of C38H72N2O12 using the declared content of azithromycin CRS. STORAGE In an airtight container . IMPURITIES Specified impurities A, B, C, D, E, F, G, H, I, J, K. [bitmap] A. R1 = OH, R2 = H, R3 = R4 = R5 = CH3: 6-demethylazithromycin, B. R1 = H, R2 = R3 = R4 = R5 = CH3: 3-deoxyazithromycin (azithromycin B), C. R1 = OH, R2 = R3 = R5 = CH3, R4 = H: 3¢-O-demethylazithromycin (azithromycin C), D. R1 = OH, R2 = R3 = R4 = CH3, R5 = CH2OH: 14-demethyl-14-(hydroxymethyl)azithromycin (azithromycin F), F. R1 = OH, R2 = R4 = R5 = CH3, R3 = CHO: 3¢-N-demethyl-3¢-N-formylazithromycin, G. R1 = OH, R2 = R4 = R5 = CH3, R3 = SO2-C6H4-CH3: 3¢-N-demethyl-3¢-N-[(4-methylphenyl)sulphonyl]azithromycin, I. R1 = OH, R2 = R4 = R5 = CH3, R3 = H: 3¢-N-demethylazithromycin, [bitmap] E. 3¢-(N,N-didemethyl)azithromycin (aminoazithromycin), [bitmap] H. 3¢-de(dimethylamino)-3¢,4¢-didehydroazithromycin, [bitmap] J. decladinosylazithromycin, [bitmap] K. (2S,4¢R,4aR,5¢S,6¢S,7R,8S,9R,10R,13R,15R,16R,17S,17aS)-7-ethyl-5¢,8,9,15-tetrahydroxy-4¢-methoxy-4¢,6¢,8,10,11,13,15,17-octamethyl-16-[[3,4,6-trideoxy-3-(dimethylamino)-b-D-xylo-hexopyranosyl]oxy]octadecahydro-5H-spiro[1,3-dioxino[4,5-m][1,6]oxazacyclopentadecine-2,2¢-[2H]pyran]-5-one (azithromycin E). Ph Eur |
2楼2010-04-15 22:54:08
mrzouhao
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ccmaodou(金币+1):谢谢参与
ccmaodou(金币+10): 2010-04-16 09:21
ccmaodou(金币+1):谢谢参与
ccmaodou(金币+10): 2010-04-16 09:21
4楼2010-04-16 08:08:46
5楼2010-04-16 09:21:33
