通过质谱法和核磁共振法鉴定伊维菌素原料药中的杂质。

Identification of impurities in ivermectin bulk material by mass spectrometry and NMR.

作者信息

Beasley Christopher A, Hwang Tsang-Lin, Fliszar Kyle, Abend Andreas, McCollum David G, Reed Robert A

机构信息

Pharmaceutical Research and Development, Merck Research Laboratories, Merck & Co., Inc., WP78-210, West Point, PA 19486, USA.

出版信息

J Pharm Biomed Anal. 2006 Jun 16;41(4):1124-34. doi: 10.1016/j.jpba.2006.02.021. Epub 2006 Mar 22.

DOI:10.1016/j.jpba.2006.02.021

PMID:16554137

Abstract

The identification and characterization of four process impurities in bulk ivermectin and four process impurities in bulk avermectin, using a combination of MS and NMR, are discussed herein. These process impurities were shown to be 24-demethyl H2B1a, 3'-demethyl H2B1a, 3''-demethyl H2B1a and 24a-hydroxy B2a isomer. The impurities were shown to be process impurities and are present in avermectin bulk also.

摘要

本文讨论了采用质谱（MS）和核磁共振（NMR）联用技术对伊维菌素原料药中的四种工艺杂质以及阿维菌素原料药中的四种工艺杂质进行的鉴定和表征。这些工艺杂质经鉴定为24-去甲基H2B1a、3'-去甲基H2B1a、3''-去甲基H2B1a和24a-羟基B2a异构体。这些杂质被证明是工艺杂质，并且也存在于阿维菌素原料药中。