Abstract

Acetanilid, p -Chloroacetanilid, and p -phenetidin are likely to be present as impurities in phenacetin. U.S.P. XVII describes qualitative tests for acetanilid and p -phenetidin and a semiquantitative paper chromatographic limit test for p -chloroacetanilid. A gas chromatographic procedure has been developed for the quantitative determination of these three impurities and of the phenacetin content of bulk material. The procedure utilizes Epon 1001 as the stationary phase on Chromosorb G in conjunction with a dual column instrument and a flame ionization detector. The proposed method is rapid and involves only a solvent extraction of the sample and no chemical modification prior to actual analysis. Impurities present in the raw materials in quantities as small as 10 p.p.m. can be estimated. If present in a proportion greater than 50 p.p.m., they may be determined quantitatively.

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