药物

  • 概述 +


    Atlas领先于市场,提供了基于人用药品技术要求国际协调委员会(ICH) Q1B稳定性测试指导方针:新型药物和产品的光稳定性试验 的首选氙灯技术(选项1)的 小型台式光稳定性曝晒测试仪器方面。它还被用于其他测试,满足ICH指导方针Q5C生物技术/生物产品的稳定性测试 ,VICH GL5稳定性测试:新型兽药和医药产品(修订)的光稳定性测试及其他相关标准。


    活性药物成分(API)以及最终药物产品(FPP)必须根据国际协调委员会的指导方针进行光稳定性测试,并由主要的政府监管机构采用。



    Atlas的SUNTEST仪器满足了选项1 D65和ID65光源的要求,这是大多数研究人员偏爱的选择,也是研究出版物中被引用最多的选择,因为它们克服了选项2荧光灯的许多限制。您大可放心,SUNTEST能够为您的监管文件提供准确和可靠的数据,包括包装决策和过期日期。

  • Atlas Solutions +


    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.


  • 测试标准 +


    • 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
  • 教育与培训 +

  • 下载 +

  • 有用链接 +


  • 视频 +

  • 录制网络研讨会 +


    消费品的耐光性和光稳定性测试 – Atlas网络研讨会 - 英语
     
    ICH和相关指南- Atlas SUNTEST®仪器中的药物光稳定性测试 - Atlas网络研讨会 - 英语