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兽药有关物质研究中的常见问题 被引量：1

General Problems in Study on the Related Substances of Veterinary Drugs
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摘要 从分析方法的选择、方法验证、定量方法和限度制订等方面入手,针对兽药有关物质研究中的常见问题进行分析并提出了建议。 The general problems in study on the related substances of veterinary drug are analyzed from the choice of methods,method validation,quantitative method and limit of developments,and suggestion is provided.
作者 刘艳华 杨大伟 郭桂芳 梁先明 段文龙
机构地区 中国兽医药品监察所
出处 《中国兽药杂志》 2012年第8期49-52,共4页 Chinese Journal of Veterinary Drug
关键词 兽药 有关物质 常见问题 veterinary drug related substances general problems
分类号 S859.79 [农业科学—临床兽医学]
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参考文献4

二级参考文献18

  • 1[2]ICH Harmonized Tripartite Guideline: Impurities In New Drug Products ,Q3B(R), 5Feb, 2003
  • 2国家食品药品监督管理局.化学药物杂质研究的技术指导原则[EB/OL].2005.http://www.sda.gov.cn/gsz05106/03.pdf.
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  • 5FDA. ANDAs: Impurities in Drug Products [EB/OL]. http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegula torylnformation/Guidances/ucm072861 .pdf.
  • 6FDA. ANDAs: Impurities in Drug Substances [EB/OL]. http://www, fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM 172002.pdf.
  • 7Hugh JC, Kenneth JN. Sample selection for analytical method development. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals. Separation Science and Technology Series [M]. Vol 5, Sandiego CA USA: Academic Press, 2003: 145-164.
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共引文献29

同被引文献35

  • 1国家药典委员会编.中国药典[s].二部.北京:化学工业出版社.2010.附录14.472.
  • 2宋丽,廖洪利,谢静,臧志和.色谱法检测药物杂质的研究进展[J].西南军医,2007,9(5):79-80. 被引量：6
  • 3ICH. Impurities in new drug substances[ EB/OL]. http://www, ich. org/fileadmin/Public Web _ Site/lCH_ Products/Guidelines/Quality/Q3A_R2/Step4/Q3A_R2 Guideline. pdf , 2006-10-25/2014-09-06.
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  • 6Rao RN, Prasad KG, Naidu CG, et al. Development of a validated liquid chromatographic method for determination of related substances of telmisartan in bulk drugs and formulations[ Jl. Journal of Pharma- ceutical and Biomedical Analysis, 2011, 56 ( 3 ) : 471-478.
  • 7Durga Rao D, Kalyanaraman L, Sait SS, et al. A validated stability- indicating normal phase LC method for clopidogrel bisulfate and its impurities in bulk drug and pharmaceutical dosage form[J]. Journal of Pha~eutical and Biomedical Analysis, 2010, 52( 1) : 160-165.
  • 8Bertolini T, Vicentini L, Boschetti S, et al. A novel automated hy- drophilic interaction liquid chromatography method using diode-array detector/electrospray ionization tandem mass spectrometry for analysis of sodium risedronate and related degradation products in pharmaceu- ticals[ J]. Journal of Chromatography A. 2014, 1365 : 131-139.
  • 9Kumar MN, Kumar KS, Kumar VJ, et al. Stability indicating ion chromatography method for the simultaneous determination of ibandr- onate sodium drug substance and its impurities[J]. Journal of Phar- maceutical and Biomedical Analysis, 2011, 54 ( 3 ) : 596-601.
  • 10Furlanetto S, Orlandini S, B. Pasquini, et al. Quality by Design ap- proach in the development of a solvent-modified mieellar electrokinet- ie chromatography method : Finding the design space for the determi- nation of amitriptyline and its impurities [ J ]. Analytica Chimica Ac- ta, 2013, 802:113-124.

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中国兽药杂志
2012年 第8期

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