Analysis of residual solvents in pharmaceuticals with purge-and-membrane mass spectrometry

Marja Ojala, Marjo Poutanen, Ismo Mattila, Raimo Ketola, Tapio Kotiaho, Risto Kostiainen (Corresponding Author)

Research output: Contribution to journalArticleScientificpeer-review

10 Citations (Scopus)

Abstract

A method using purge‐and‐membrane mass spectrometry (PAM‐MS) was developed for the analysis of residual solvents in pharmaceutical products. The method combines dynamic headspace and membrane inlet mass spectrometry. The limits of detection for the compounds studied, benzene, toluene, chloroform, 2‐pentene and 2‐methyl‐ and 3‐methylpentane, were 0.05–0.1 mg/kg. In quantitative analysis the method showed good linearity (r2 > 0.998) and acceptable within‐day (RSD = 7.9–18%) and between‐day (RSD = 6.8–10%) repeatability. The PAM‐MS method combined with the custom‐made Solver program was compared with a method using purge‐and‐trap gas chromatography/mass spectrometry (P&T‐GC/MS) for identification of residual solvents from authentic samples. The results showed that PAM‐MS/Solver provides reliable identification of the main volatile organic compounds (VOCs) in the pharmaceuticals, but VOCs with low concentrations (below 0.5 mg/kg) were better identified by P&T‐GC/MS. Other advantages of the PAM‐MS method were short analysis times and non‐requirement for pre‐treatment of samples.
Original languageEnglish
Pages (from-to)994-998
JournalRapid Communications in Mass Spectrometry
Volume14
Issue number11
DOIs
Publication statusPublished - 2000
MoE publication typeA1 Journal article-refereed

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