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小木虫论坛-学术科研互动平台 » 生物医药区 » 新药研发 » 质量控制 » 【求助】英国药典阿奇霉素质量标准
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ccmaodou

木虫 (小有名气)

[交流] 【求助】英国药典阿奇霉素质量标准已有6人参与

英国药典阿奇霉素质量标准！

先谢谢了！
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1楼2010-04-15 22:45:27
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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
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。

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8楼2010-04-23 11:33:56
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jinyixiao

至尊木虫 (著名写手)
★
ccmaodou(金币+1):谢谢参与
ccmaodou(金币+20):十分感谢！ 2010-04-16 08:17
(Ph Eur monograph 1649)
  


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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.
  


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 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,
  


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 E. 3¢-(N,N-didemethyl)azithromycin (aminoazithromycin),
  


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 H. 3¢-de(dimethylamino)-3¢,4¢-didehydroazithromycin,
  


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 J. decladinosylazithromycin,
  


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 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
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2楼2010-04-15 22:54:08
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jinyixiao

至尊木虫 (著名写手)
上面是英国药典（2007）上面的相关内容。其中一些分子结构式显示不出。
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3楼2010-04-15 22:56:51
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mrzouhao

木虫之王 (文坛精英)
★
ccmaodou(金币+1):谢谢参与
ccmaodou(金币+10): 2010-04-16 09:21
http://www.newdruginfo.com/ypbz/bzjs/aqms.htm
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4楼2010-04-16 08:08:46
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