医薬品

  • 概要 +


    アトラスは、ヒト用医薬品の技術要件に関する医薬品規制調和国際会議(ICH)ガイドラインQ1B安定性試験の好ましいキセノンアークランプ技術(オプション1)に基づく小型の卓上型光安定性暴露試験装置を提供するリーダーです。新薬の物質および製品の光安定性試験。また、ICHガイドラインQ5Cバイオテクノロジー/生物学的製剤の安定性試験、VICH GL5安定性試験、VICH GL5 安定性試験:新規動物用医薬品原薬及び医薬品の光安定性試験(改訂版)、その他関連規格の試験にも使用されています。


    医薬品有効成分(API)および最終医薬製品(FPP)は、医薬品規制調和国際会議ガイドラインに従って光安定性試験を行う必要があり、主要な政府規制機関によって採用されています。



    アトラスのSUNTESTは、オプション2の蛍光灯式チャンバーの多くの制限を克服し、ほとんどの研究者に好まれ、研究論文で最も引用されているオプション1のD65とID65光源の要件を満たしています。SUNTESTは、包装の決定や有効期限を含む規制当局への提出物に対して、正確で正当なデータを提供できます。

  • アトラスが提供するソリューション +


    The SUNTEST CPS+ and XLS+ benchtop models provide the ideal size and capability for most pharmaceutical testing needs, including powders, solutions, tablets and capsules, injectables, packaging, etc. The SUNTEST XLS+ is the most used model as it has the chamber size to test blister packs, final packaging, and powders using our optional powder apparatus. An optional cooling system, SunCool, is recommended for lower test chamber temperatures for thermally labile API’s or FPP’s such as gel-caps. The larger SUNTEST XXL+ is sized for exposing larger scale specimens for stability testing of packaging and medical devices.



    The SUNTEST can switch between the D65 outdoor daylight to ID65 window glass filtered spectra with a simple optical filter change. This makes for more versatile testing options for meeting both the Q1B minimum confirmatory requirement testing as well as the forced-degradation requirement.

    The SUNTEST’s Option 1 xenon light source provides for rapid testing – confirmatory testing can be met in hours, not the week or more required by Option 2 sources, with both the ultraviolet (UV) and visible light exposures occurring simultaneously, with no need to switch lamps or run consecutive tests. The precision xenon light source fully meets the international D65 and ID65 spectral requirements, unlike many of the Option 2 fluorescent sources on the market, and has no potentially dangerous “wavelength gap” between the UV and visible light emissions.


  • 規格と試験方法 +


    • ICH Q1B Stability Testing: Photostability Testing of New Drug Substances
    • ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological / Biological Products
    • Regulatory and similar agencies which adopt ICH Guidelines in whole or in part, such as US Food & Drug Agency, European Medicines Agency, Japan Ministry of Health, Labor and Welfare, Health Canada, World Health Organization, European Free Trade Association, ASEAN, and others.
    • VICH GL5 Guideline On Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products
  • 教育と訓練 +

  • 資料ダウンロード +

  • 参考リンク +


  • Videos +

  • ビデオセミナー +


    Lightfastness and Photostability Testing of Consumer Goods – Atlas Online Seminar
     

    ICH and Related Guidelines - Pharmaceutical Photostability Testing in Atlas SUNTEST® Instruments - Atlas Online Seminar