Recommanded Product: 1-(Dimethylamino)-3-(2-(3-methoxyphenethyl)phenoxy)propan-2-ol hydrochlorideOn September 10, 2019 ,《Determination of epoxide impurity in sarpogrelate hydrochloride intermediate by UHPLC and column-switching liquid chromatography》 was published in Journal of Pharmaceutical and Biomedical Analysis. The article was written by Wang, Ran; Zhu, Zhiling; Qiu, Xiaodan; Bai, Liping; Guo, Weiwei; Zuo, Limin; Zhao, Ting; Shan, Guangzhi. The article contains the following contents:
The determination of genotoxic impurities, which is closely related to toxicol. concern and daily dose, plays a key role in drug quality control. Epoxide impurity is a kind of genotoxic impurity with an epoxy ring structure during the synthesis process of sarpogrelate hydrochloride. According to the sarpogrelate hydrochloride daily dose, epoxide impurity is limited to the under 5 ppm level. The liquid chromatog.-tandem mass spectrometric (LC/MS/MS) or the gas chromatog.-mass spectrometric (GC/MS) method is commonly used to characterize the epoxide impurity of sarpogrelate hydrochloride intermediates. However, these methods are not simple or economical enough to detect epoxide impurity. In this study, we resolved the problem by using the most common UV method with two ideas: one was to improve the absolute sensitivity, and the other was to reduce matrix effects. Both ultra high-performance liquid chromatog. (UHPLC with high sensitivity LightPipe flow cells) and column-switching liquid chromatog. methods were developed and validated for the quant. determination of epoxide impurity in sarpogrelate hydrochloride intermediates. The limits of detection (LODs) of the UHPLC and column-switching liquid chromatog. methods were 0.09 ppm (0.09μg/g) and 0.33 ppm (0.33μg/g), and the recovery rates of both methods were 87.2%-132.1% and 97.4%-100.1%, resp. Both methods established and provided guidance for analysts to develop procedures for impurity control, especially for structures of impurity with similar matrixes. In the experimental materials used by the author, we found 1-(Dimethylamino)-3-(2-(3-methoxyphenethyl)phenoxy)propan-2-ol hydrochloride(cas: 135261-74-4Recommanded Product: 1-(Dimethylamino)-3-(2-(3-methoxyphenethyl)phenoxy)propan-2-ol hydrochloride)
1-(Dimethylamino)-3-(2-(3-methoxyphenethyl)phenoxy)propan-2-ol hydrochloride(cas: 135261-74-4) belongs to anime. To avoid the problem of multiple alkylation, methods have been devised for “blocking” substitution so that only one alkyl group is introduced. The Gabriel synthesis is one such method; it utilizes phthalimide, C6H4(CO)2NH, whose one acidic hydrogen atom has been removed upon the addition of a base such as KOH to form a salt.Recommanded Product: 1-(Dimethylamino)-3-(2-(3-methoxyphenethyl)phenoxy)propan-2-ol hydrochloride
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