2-CHEMTURA-Naugalube531
长春西汀注射液中2种磺酸酯类基因毒性杂质的测定
•检验检测•/nspecths and Test221年5月2日第3卷第1期Voi.55,No.15,May25,2521 China PharmaceuticalsdU：D.3969/j.imn.1006-4930202010.014长春西汀注射液中2种磺酸酯类基因毒性杂质的测定焦洁，妙苗，王涛，蔡虎(陕西省食品药品监督检验研究院・国家药品监督管理局药品微生物检测技术重点实验室，陕西西安710065)摘要：目的建立测定长春西汀注射液中对甲苯磺酸甲酯和对甲苯磺酸乙酯含量的高效液相色谱法。
方法色谱柱为Waters ODS2C k柱((90mmx4.6mm,5im),流动相为乙腈-0.1%磷酸溶液(39:61,V/V)，流速为00mL/min,检测波长为226nm,柱温为35C,进样量为22iL结果对甲苯磺酸甲酯、对甲苯磺酸乙酯质量浓度分别在01145 9〜0.5998ig/mL和0. 1134〜0. 4542ig/mL范围內与峰面积线性关系良好(=0.9999,0.9998),平均回收率分别为98.78(RSD=2.02%,p二6)和99.33%(RSD=027%,p二6)。
结论该方法简便、准确，可用于长春西汀注射液中对甲苯磺酸甲酯和对甲苯磺酸乙酯的定性和定量分析。
关键词：高效液相色谱法；长春西汀注射液；对甲苯磺酸甲酯；对甲苯磺酸乙酯；磺酸酯类；基因毒性杂质中图分类号:R927.2;R972文献标志码:A文章编号:1006-4931(2221)10-0054-03ContenS Determination of Two Genotoxic Impuritiee of Sulfonatr Esters in Vinpocetine InjectionJIAO Jie,MIAO Miao,WANG Tao,CAI Hu牗Shaapxi Ins///far Food and Drug Control•NMP4Key Laboratory of Drug Marobiologicol DelecUon Technology,Xi'ao,Shaaoxi,Chino710065)Abstract：Objective To estab/sh an high-pe/ormadce liquid chromatouranPy(HPLC)methop foe the contenI determination of the methyl p-toluene sulfonate and ethyi p-toluene sulfonate in VinpoceUne Injechon.Methode The chromatorgradPic column was Ci7 column((96mm x4.6mm,5im),the moPiio pPaso was acetomtriie-0.1%phospho/c acid soluhon(35：61,V/V),the tow rate was 00mL/min,the Uetechon wavelenath was226nm,the column temperature was35C,and the injechon volume was20%iL. ReseOe The hdear ranaos of methyl p-toluene sulfonate and ethyl p-toluene sulfonate were0.1459-0.5998ig/mL(厂=0.9999) and0.1136-0.4542ig/mLu0.9998),respectively.The averayo recoverms of methyl p-toluene sulfonate and ethyl p-toluene sulfonate were90.78%(RSD=2.02%,p二6)and99.33%(RSD二027%,p=6),resuechvely.Conclusion This methop is simpio and acch-rate,which can be useU foe the quahtahve and quanhtahve analysis of methyl p-ttPuene sulfonate and ethyl p-ttPuene su/onate in VinpcpeUne Injec/ohKey wordt:HPLC;Vinnocetine Injection;methyl p-toluene sulfonate;e t hyl p-toluene sulfonate;s u lfonate esters;genotoxic长春西汀注射液是由主药长春西汀和辅料山梨醇、苯甲醇等经现代工艺精制而成的无菌注射液，临床主要用于改善脑梗死后遗症、脑出血后遗症、脑动脉硬化症等诱发的各种症状其主药以长春胺为起始原料，经脱水消除、水解和酯化制得。
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Naugalube ®
531
liquid hindered phenolic
Issued: 8/2001
The information contained herein is correct to the best of our knowledge. Your attention is directed to the pertinent Material Safety Data Sheets for the products mentioned herein. All sales are subject to Chemtura's standard terms and conditions of sale, copies of which are available upon request and which are part of Chemtura's invoices and/or order acknowledgments. Except as expressly provided in Chemtura's standard terms and conditions of sale, no warranty, express or implied, including warranty of merchantability or fitness for particular purpose, is made with respect to the products described herein. Nothing contained herein shall constitute permission or recommendation to practice any invention covered by a patent without a license from the owner of the patent.
Chemtura Corporation
Technical Service 800.336.9315 Petroleum Additives
Customer Service 800.325.6252 199 Benson Road
Fax 203.573.2324 Middlebury, CT 06749
DESCRIPTION Naugalube 531 is a liquid hindered phenolic for use as an antioxidant in mineral
and synthetic base stocks that are typically employed in lubricant applications. It
is recommended for applications that operate below 140°C. For applications that
operate at greater than 140°C, Naugalube 531 can be easily used in conjunction
with a diphenylamine antioxidant such as Naugalube ® 438L to prevent
degradation. Naugalube 531 can easily be incorporated into engine oils, gear oils,
turbine oils, hydraulic fluids, compressor oils, and greases.
8H 17
3,5-di-tert-butyl-4-hydroxyhydrocinnamic acid, C 7-C 9 branched alkyl ester
TYPICAL
DATA Properties Typical Assay, % 99.4
Specific Gravity (25°C) 0.985
Flash Point, Cº 148
Ash Nil
Toluene Insolubles, % < 0.01
Appearance Clear Yellow Liquid
Viscosity, cSt (40ºC) 114
Pour Point, Cº -21
Gardner Color 4
Moisture, ppm 180
HANDLING INFORMATION It is recommended that Naugalube 531 be stored in a cool dry area.
SAFETY INFORMATION For more extensive information on the safe handling and use of this product,
please refer to the Material Safety Data Sheet.
SHIPPING INFORMATION
Naugalube 531 is available in both bulk and drums.。