应《网络安全法》要求，自2017年10月1日起，未进行实名认证将不得使用互联网跟帖服务。为保障您的帐号能够正常使用，请尽快对帐号进行手机号验证，感谢您的理解与支持！

24小时热门版块排行榜    

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
51/1返回列表
查看: 2216  |  回复: 7
只看楼主 @他人 存档 新回复提醒 (忽略) 收藏    在APP中查看
当前只显示满足指定条件的回帖，点击这里查看本话题的所有回帖

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！
回复此楼

» 收录本帖的淘帖专辑推荐

一致性评价

» 猜你喜欢

» 本主题相关价值贴推荐，对您同样有帮助:
1楼 2010-04-15 22:45:27
已阅   回复此楼   关注TA 给TA发消息 送TA红花 TA的回帖

9123pharma

铁虫 (小有名气)

阿奇霉素(Azithromycin)市场客户综述

★
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。

Our focus, your success!
Subscribe today to stay ahead of competition!
赞一下(1人) 回复此楼
仿制药产品筛选
8楼2010-04-23 11:33:56
已阅   回复此楼   关注TA 给TA发消息 送TA红花 TA的回帖
查看全部 8 个回答

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)
  


[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
赞一下(1人) 回复此楼
2楼2010-04-15 22:54:08
已阅   回复此楼   关注TA 给TA发消息 送TA红花 TA的回帖

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。
赞一下 回复此楼
3楼2010-04-15 22:56:51
已阅   回复此楼   关注TA 给TA发消息 送TA红花 TA的回帖

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
赞一下(1人) 回复此楼
4楼2010-04-16 08:08:46
已阅   回复此楼   关注TA 给TA发消息 送TA红花 TA的回帖
查看全部 8 个回答
普通表情 龙 兔 虎 猫 高级回复 (可上传附件)
最具人气热帖推荐 [查看全部] 作者 回/看 最后发表
[考研] 295求调剂。一志愿报考郑州大学化学工艺学硕，总分295分 +5 yl1 2026-03-02 5/250 2026-03-02 15:24 by sucesssucess
[考研] 0856化工专硕求调剂 +15 董boxing 2026-03-01 15/750 2026-03-02 15:06 by 晃晃不许晃
[考研] 江苏省农科院招调剂1名 +4 Qwertyuop 2026-03-01 4/200 2026-03-02 14:27 by 升格阿达
[考研] 290分材料工程085601求调剂 数二英一 +3 llx0610 2026-03-02 3/150 2026-03-02 14:15 by yc258
[考研] 化工专硕348，一志愿985求调剂 +6 弗格个 2026-02-28 9/450 2026-03-02 14:09 by liyongv
[考研] 085600 英一数二272求调剂 5+4 vida_a 2026-03-01 10/500 2026-03-02 12:33 by vida_a
[考研] 284求调剂 +10 天下熯 2026-02-28 11/550 2026-03-02 11:03 by 无际的草原
[考研] 264求调剂 +4 巴拉巴拉根556 2026-02-28 4/200 2026-03-02 10:48 by yuchj
[考研] 材料调剂 +6 爱擦汗的可乐冰 2026-02-28 7/350 2026-03-02 10:42 by Jy?
[考研] 275求调剂 +3 L-xin? 2026-03-01 6/300 2026-03-02 10:22 by 热情沙漠
[考研] 0856材料调剂 +4 沿岸有贝壳OUC 2026-03-02 4/200 2026-03-02 10:19 by 公瑾逍遥
[考研] 材料工程269求调剂 +3 白刺玫 2026-03-02 3/150 2026-03-02 09:25 by 一休哥FU
[考研] 材料复试调剂 +4 学材料的点 2026-03-01 5/250 2026-03-02 08:26 by houyaoxu
[考研] 306分材料调剂 +4 chuanzhu川烛 2026-03-01 5/250 2026-03-01 19:48 by 无际的草原
[考研] 0856材料求调剂 +4 麻辣鱿鱼 2026-02-28 4/200 2026-03-01 16:51 by caszguilin
[考研] 313求调剂 +3 水流年lc 2026-02-28 3/150 2026-03-01 16:01 by 新能源达人
[考研] 307求调剂 +5 wyyyqx 2026-03-01 5/250 2026-03-01 15:21 by Fff-1
[考研] 317一志愿华南理工电气工程求调剂 +6 Soliloquy_Q 2026-02-28 11/550 2026-03-01 11:14 by 歌liekkas
[硕博家园] 2025届双非化工硕士毕业，申博 +3 更多的是 2026-02-27 4/200 2026-03-01 10:04 by ztg729
[考研] 085600材料工程一志愿中科大总分312求调剂 +8 吃宵夜1 2026-02-28 10/500 2026-02-28 20:27 by L135790
信息提示
关闭
请填处理意见
关闭