IDENTIFICATION AND QUANTITATION OF IMPURITIES IN METHOTREXATE

被引:18
作者
CHATTERJI, DC [1 ]
FRAZIER, AG [1 ]
GALLELLI, JF [1 ]
机构
[1] NIH,CTR CLIN,DEPT PHARM,BETHESDA,MD 20014
关键词
Antineoplastic agents—methotrexate; chromatographic separation; UV; NMR; and mass spectral analyses of impurities in various formulations; Impurities—in various formulations of methotrexate; and mass spectral analyses; Methotrexate—chromatographic separation;
D O I
10.1002/jps.2600670512
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
The impurities in bulk, commercial, and investigational methotrexate samples were chromatographically separated by gradient elution from a diethylaminoethylcellulose column. Besides the already known impurities in the bulk and commercial samples, two other impurities, 4‐amino‐N10‐methylpteroyl‐N‐methylglutamine and 2,4‐diamino‐N10‐methylpteramide, were identified. A new batch of methotrexate, synthesized for the National Cancer Institute for investigational use only, showed a different spectrum of impurities. The purity of all methotrexate samples studied was about 86% calculated on an anhydrous basis. Copyright © 1978 Wiley‐Liss, Inc., A Wiley Company
引用
收藏
页码:622 / 624
页数:3
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