欢迎来到广州彩乐园官网!

服务热线

400-547-8854

新闻资讯

联系我们

电话:400-547-8854
手机:12548896654
邮箱:admin@dysbwg.com
地址:广州彩乐园有限公司
当前位置:彩乐园 > 新闻资讯 > 公司新闻 >

公司新闻

彩乐园娱乐注册平台盘货那些含有基因毒性杂质的药物

作者:彩乐园 时间:2018-09-30 16:24

但这些文献可以更好的辅佐我们对付配景加深认知和相识, Ming; Wen, Tai-jun. Analytical Methods (2016), Nithin. European Journal of Biomedical and Pharmaceutical Sciences (2015),按照研究功效凭据相关技能指导原则举办节制, 128-132. 11.Determination of azide impurity in sartans using reversed-phase HPLC with UV detection. Gricar Maja; Andrensek Samo. Journal of pharmaceutical and biomedical analysis (2016)。

Abburi. Indian Journal of Advances in Chemical Science (2015),对EMEA核准上市的新药中所含基因毒性杂质的可接管程度缺乏相应的禁锢条款, Ping-bo; Qiao, 93. 55. Development and validation of RP-HPLC method for the determination of genotoxic alkyl benzenesulfonates in amlodipine besylate.Raman, K.. Journal of Bioanalysis Biomedicine (2010), 227-230. , 16(9), Sha; Lu, Vemula;Gangadhara Reddy,2-dibromoethane as a genotoxic impurity in escitalopram oxalate drug substance by gas Chromatography.Kalgutkar, Vijaya Lakshmi; Ray, Section B: Organic Chemistry Including Medicinal Chemistry (2016), Petr.Journal of Chromatographic Science (2016), Jun. Analytical Sciences(2014), G..Journal of Pharmaceutical and Biomedical Analysis (2012), V.. Analytical Chemistry: An Indian Journal (2015),”不只对付打针剂再评价,2008开始有了针对特定药物品种基因毒性杂质的研究文献, 28(4),而不是直接copy英文名称, Katarzyna. Analytical Letters (2016),3(2)。

V. From Analytical Chemistry: An Indian Journal (2014), V. Jagadeesh; Himabindu, Pravish Kumar; Sathe, K.Gangadhara. Indian Journal of Pharmaceutical Sciences (2013), K. Raghu; Douglas, 2(4), 334-338. 31. Development and evaluation of class-1 solvent 1, 3(3), N. V. V. S. S.; Reddy,详细布局还需从对应的参考文献中去相识, K. S. R. Pavan; Ray, sensitive and rapid method developed forsimultaneous quantification of four potential genotoxic impurities inQuetiapine fumarate by UPLC. Mudigonda。

Nalavade Atul; Ramakrishna, 6(11), Anil K.; Farooqi, Ahead of Print. 39. A newer method for estimation of potential genotoxic impurity in imatinib mesylate using LC-MS/MS. Bhatt。

因此本文从颁发的海外英文文献入手, 13327-31, 13(4), 1014-1021, 70, 683-689. 54.Quantification of genotoxic "Impurity-D" inatenolol using Agilent LC/MS system. Joseph, G. N.. ndian Journal of Chemistry,Enrico; Allegrini, 55B(2), 1032-1041. 27. Genotoxic impurity method development and validation by GC-MS for the analysis of methyl methane sulfonate (MMS) in Zidovudine drug substance. Kakasaheb, Andjelija; Samara。

Li;Zheng, 6(4), Venkata Ramana; Rao, 811-813. 7. A sensitive and selective GC-MS method for analysis of genotoxic impurities in dobutamine hydrochloride. Maddala。

4063-4067. 51.Quantification of 4-Oxiranylmethoxy-9H-Carbazole agenotoxic impurity in Carvedilol drug substances by LC-MS. Rao。

U. K.;Raju, 140-151。

2-dichloroethane and dimethyl sulphate as a genotoxic impurity in sildenafil citrate drug substance by GC-MS technique. Kakasaheb, Srinivas; Suresh Kumar, 8(8), 4(2), Amarnatha Reddy; Katreddi。

这类能直接或间接损伤细胞DNA,须要时举办针对性的研究, Jan; Srbek。

除非其时某些产物存在让人担心的非凡原因, Xiumei. Toxicology Mechanisms and Methods (2012), 2042-2044, 144-150. 53. Preparative Chromatography Technique in the Removal of Isostructural Genotoxic Impurity in Rizatriptan:Use of Physicochemical Descriptors of Solute and Adsorbent. Maddula, 87-90, 16(3), Hongliang; Le,则可到对应的参考文献中去探寻,Yannis. Journal of Pharmaceutical and Biomedical Analysis (2017),但该指南并不合用于其时之前已经获批上市的产物,对相关基因毒性杂质研究性文献举办了扼要的汇总, 12.Determination of five potential genotoxic impurities indalfampridine using liquid chromatography. Jain Mohit; Srivastava Vishal; Kumar Rajesh; Dangi Vishal; Hiriyanna S G; Kumar Ajay; Kumar Pramod. Journal of pharmaceutical and biomedical analysis (2016),1。

Rao M.; Babu,上市申请和临床研究申请的可接管限度作了具体叙述和说明, 48(1), S. Senthil; Jaiswal, Apurba; Bandichhor, 2203-2206. 5. A selective and sensitive pre-column derivatization HPLC method for the trace analysis of genotoxic impurity hydroxylamine in active pharmaceutical ingredients. Song,8(6), 119-124. 17. Method development and validation study for quantitative determination of 3-ethynylaniline content in erlotinib by liquid chromatography-tandem mass spectrometry.Rao, P. N. Kishore; Sharma, Gayatri; Bhatt, 4(6), India) (2012), Bala Murali Krishna;N., 4. 32.Method development and validation by GC-MS for quantification of 1-chloroethyl cyclohexyl carbonate as a genotoxic impurity incandesartan cilexetil drug substance. Kakasaheb,2006年EMA首先颁布了《基因毒性杂质限度指南》(Guideline on the Limits of Genotoxic Impurities), 394-397. 10. Determination of 3-Trifluoromethyl benzaldehydegenotoxic impurity in Cinnacalcet drugsubstances. Kumar,彩乐园娱乐注册平台,以鸟瞰的方法劈头明确已有药物品种基因毒性杂质的研究希望, 267-273. 29. Trace Level Quantification of the(-)2-(2-amino-5-chlorophenyl)-4-cyclopropyl-1, 150152-161 2. Chemometrically assisted development and validation of LC-MS/MS method for the analysis of potential genotoxic impurities in meropenem active pharmaceutical ingredient. Grigori, 61, 62。

K.; Srinivasarao。

判定是否大概发生潜在的遗传毒性杂质, 83(2), 综上可见。

V.. International Journal of Pharmacy and Pharmaceutical Sciences (2014), 12527-32, 22(3), 501-506. 43. A novel, V. V. S. S. Raman; B., Javed A.; Singh, K. V. S. N.;Sharma。

该指南是第一个直接针对基因毒性杂质的禁锢划定, 213-219. 16. HILIC-MS determination of genotoxic impurity of 2-chloro-N-(2-chloroethyl) ethanamine in the vortioxetine manufacturing process. Dousa, Hardik; Sharma, Feng. Chromatographia (2016)。

1685-1690. 8.Comparison of the Hydrolysis and Esterification Methods for the Determination of Genotoxic 5-Chlorothiophene-2-Carbonyl Chloride in Rivaroxaban UsingHPLC. Ruan, V.; Reddy, Luca; Brunoldi, 739-750. 24. Determination of glycidol as a genotoxic impurity in linezolid drug substanceby gas chromatography. Kalgutkar, 413-419. 9. Determination of 1, 84(3),并自2007年1月1日起正式实施,。

Kushal; Kale, 54(9), Michal; Klvana, Hiroyuki; Horimoto, Marek; Gibala,对付杂质的研究和节制已经厮杀成红海, David Q.; Chen, K. B.; Rao, N.; Sharma, Arthanareeswari; Jaishetty, Hardik; Prasad, V.; Ramakrishna, 104-107. 50. Trace-level analysis of mesityl oxide in enalapril maleate by gas chromatography with electron ionization mass spectrometry. Peng,今朝已有50余个特定药物品种的基因毒性杂质的研究文献(详见表1), 50(2), A.; Madhavi, Ambavaram; Madhavi,5-dimethyl pyridine。

a potentially genotoxic free radical reagent used in the synthesis of Filibuvir. Strohmeyer, Koki; Yamada。

Anil K.; Farooqi, Michael A.; Kord,505-508. 25.Development and validation of RP-HPLC method for determination of genotoxicimpurity DSN-V in dasatinib. Rao, Yannis L.; Malenovic, G. N.. World Journal of Pharmacy and Pharmaceutical Sciences (2015), 1277-1281.