Crystallization and Subsequent Freeze-Drying of Cephalothin Sodium by Seeding Method

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  • セファロチンナトリウムの種晶添加晶析凍結乾燥法
  • セファロチン ナトリウム ノ シュ ショウテンカ ショウセキ トウケツ カンソ

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Abstract

Cephalothine sodium (CET-Na) in crystals can be obtained by freezing the aqueous solution and subsequent warming at a fixed temperature for facilitating crystallization prior to vacuum application for drying. The product has, however, been found to unavoidably contain traces of the amorphous CET-Na, which causes a rapid color development during storage. By using thermal analysis, differential scanning calorimetry (DSC), electric conductometry, and polarized light cryomicrographic techniques, the solubilities in water, freezing point, eutectic point, and melting behavior of CET-Na in aqueous solution were investigated. The investigation demonstrated that CET-Na in supersaturated aqueous solution is very stable, and that seeding with microcrystalline CET-Na to the supersaturated solution and subsequent cooling of the mixture till its freezing point gives neither any evidence for crystallization nor for growth of the seed crystals. The freeze-drying of CET-Na in the supersaturated solution after seeding has been demonstrated to give crystalline CET-Na contaning neither of amorphous nor of quasicrystalline form.

Journal

  • YAKUGAKU ZASSHI

    YAKUGAKU ZASSHI 109 (6), 395-401, 1989

    The Pharmaceutical Society of Japan

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