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Establishment of a Knowledge Base for Prescreening Residual Solvents in Pharmaceuticals

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Abstract

A knowledge base for determining residual solvents in pharmaceuticals has been established using static headspace gas chromatography (HS-GC). Fifty-one solvents which belong to four different classes according to the guideline for residual solvents regulated by the International Conference on Harmonization were studied. Two columns with opposite polarity, SPB-1 and HP-FFAP, were used and the relative retention time was the qualitative parameter in the knowledge base. With the aid of the knowledge base, unknown residual solvents in pharmaceuticals can be identified promptly and suitable methods for determining residual solvents can be developed rapidly.

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Authors and Affiliations

  1. National Institute for Control of Pharmaceutical and Biological Products, Beijing, 100050, P.R.China

    Chang-qin Hu & Li-hui Yin

  2. Yunnan Institute for Drug Control, Kunming, 650011, P.R. China

    Li Qin

Authors
  1. Li Qin
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  2. Chang-qin Hu
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  3. Li-hui Yin
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Correspondence to Chang-qin Hu.

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Qin, L., Hu, Cq. & Yin, Lh. Establishment of a Knowledge Base for Prescreening Residual Solvents in Pharmaceuticals. Chromatographia 59, 475–480 (2004). https://doi.org/10.1365/s10337-004-0211-2

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  • DOI: https://doi.org/10.1365/s10337-004-0211-2

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