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Static headspace gas chromatography of residual solvents in pharmaceutical products

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Summary

A headspace, gas chromatographic method for determining residual solvents in pharmaceutical products such as the gonadotrophin powders, has been developed.

The method allows the determination of residual solvents by transferring the samples directly into a vial contianing 10 mL 2M sodium chloride; the analysis is carried out by sampling the headspace and separating by capillary gas chromatography using a programmedtemperature vaporizer (PTV) injector.

The procedure described is simple, sensitive and reproducible. The lower limit of detection is 20 ppb for ethyl alcohol, 8 ppb for acetone and 0.5 ppb for diethyl ether.

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Authors and Affiliations

  1. Dipartimento di Chimica, Università “La Sapienza” Roma, P. le Aldo Moro 5, 00185, Roma, Italy

    M. V. Russo

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  1. M. V. Russo
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Russo, M.V. Static headspace gas chromatography of residual solvents in pharmaceutical products. Chromatographia 39, 645–648 (1994). https://doi.org/10.1007/BF02274577

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  • DOI: https://doi.org/10.1007/BF02274577

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