Organic Process Research and Development p. 59 - 64 (2016)
Update date:2022-08-11
Topics:
Yang, Rong-Sheng
Beard, Adam
Sheng, Huaming
Zhang, Li-Kang
Helmy, Roy
The ICH has strict guidelines for limiting the presence of potentially mutagenic impurities (PMIs) in marketed drugs. Therefore, it is important to fully characterize and quantitate all possible PMIs that could arise during the process of synthesizing and developing a drug. Two important and prevalent examples of PMIs are compounds containing N-oxide and nitro functional groups. TiCl3 derivatization is an established method for determining the presence or absence of N-oxide metabolites by reduction to the corresponding amine. In this study, we demonstrate a novel application of TiCl3 reduction combined with high-resolution UHPLC/HRMS to analyze PMIs. The results indicate that a variety of N-oxide- and nitro-containing compounds can be readily characterized by this facile platform method. In addition, we show that this chemical derivatization method can be utilized to enhance the ionization of nitro-containing compounds for LC/MS analysis.
View MoreTaizhou YOJOY Chemical Co., Ltd.
Contact:13857143241
Address:Yangfu Industrial Park, Xianju, Zhejiang, P. R. China
Beijing Mesochem Technology Co.,LTD
website:http://www.mesochem.com
Contact:0086-10-57862036
Address:2301, Floor 23, Building 9 Lippo Plaza, Yard 8 Ronghua Middle Road, ETDZ, Beijing, China
Changzhou Baolong Chemical Industrial Co.,Ltd
website:http://www.czbaolong.com
Contact:0519-85720726 0519-85720721 13951213302
Address:No.1,Weihua Road,Xinbei District,Changzhou City,Jiangsu Province
Nanjing Qirui Material Co., Ltd.
Contact:+86-25-52320053
Address:F4-5, #17 Building, Chuang Yi Yuan, No.6 Guanghua East Street, Nanjing, 210007 P.R.China
website:http://www.easchem.com
Contact:+86-731-89722861 89722891
Address:2/F-4/Bld Colorful Palace, No.605 Changsha Ave, Yuhua Area Changsha Hunan China.
Doi:10.2174/1570178612666150415235453
(2015)Doi:10.1016/S0040-4020(01)91960-X
(1983)Doi:10.1039/c2ce26201k
(2012)Doi:10.1002/jhet.5570350616
(1998)Doi:10.1016/j.fitote.2014.05.007
(2014)Doi:10.1039/c4ce00917g
(2014)