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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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英国药典阿奇霉素质量标准！ 先谢谢了！ |
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9123pharma
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阿奇霉素(Azithromycin)市场客户综述
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小木虫(金币+0.5):给个红包，谢谢回帖交流
小木虫(金币+0.5):给个红包，谢谢回帖交流
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阿奇霉素(Azithromycin)市场客户综述 Azithromycin作为大环内酯类抗生素前景非常看好，目前因为疗效好副作用少和专利方面因素影响，其在近5－8年市场都非常不错。 Azithromycin的化合物专利早在1981年已经申请，至现在各国都已经过期。中国因为法律立法原因其化合物专利不可能受到保护，国内外都无需规避。但国内外存在许多关于azithromycin的方法、制剂、物质专利。 国内通过GMP生产azithromycin的有26家，做制剂的厂家很多。其原料药和制剂都有进口，均从Pfizer进口。 国内没有工厂获得azithromycin的COS证书，但有三家持有USDMF证书，其它持有证书的主要来自欧洲和印度。国内有四家厂家向印度供应原料药。 Azithromycin的原料药客户分布大致情况为：主要集中在南美、东南亚、北美、欧洲，南美主要为哥伦比亚、墨西哥、智利、秘鲁，东南亚主要是印度、韩国、孟加拉、越南等，欧洲主要为东欧国家如俄罗斯、匈牙利、捷克等。国内有三家公司向秘鲁出口azithromycin制剂。 Our focus, your success! Subscribe today to stay ahead of competition! |
8楼2010-04-23 11:33:56
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
jinyixiao
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3楼2010-04-15 22:56:51
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
