质量控制

原材料分bob综合游戏析

Identity Check of Incoming Goods

快速可靠的识别和对传入原材料的验证对于药物制造至关重要。bob综合游戏

在制造药品API和药品产品中,原材料中的杂质和掺假剂构成了潜在的健康bob综合游戏威胁。这些相同的杂质和掺假剂也可能导致产量较低和产品纯化需求。因此,他们在传入原材料中的识别和量化在制药行业中起着重要作用,确保产品安全和质量以及整体平稳且经济高效的制造过程。

布鲁克(Bruker)提供了一个完整的分析系统组合,以快速准确地识别原材料。bob综合游戏

X射线荧光(XRF)是一种可靠,精确且准确的技术,有可能在PPM中分析PPM或什至子PPM水平的无机杂质,以在制药行业使用的许多类型的原材料中。bob综合游戏XRF也是快速识别某些物质的理想选择,例如KCL和NaCl的分化。现代高端实验室能量分散XRF spectrometers允许高吞吐量,易于操作,并符合适用的数据管理法规(例如21 CFR第11部分)。便携式XRF单元可用于快速评估到达后的新交付。

与更古典的湿化学技术相比,XRF的关键优势是快速,简单的样品制备,易用性和低操作成本(无需有毒/昂贵的化学药品/气体!

Uniquely, XRD directly probes the atomic and molecular arrangements in solid forms. X-ray powder diffraction, therefore, enables detection, identification, and quantification of crystalline and amorphous APIs, excipients, and other any materials via fingerprinting. Raw materials can be quickly screened to control purity, crystallinity, and polymorphism as well as absolute phase abundance in mixtures.

FT-NIR光谱法通过光纤探针正在迅速成为实现这种关键材料验证的标准方法,从而为识别固体材料和液体提供了前所未有的速度和灵活性。bob综合游戏

BothMPAiiandmatrix-fFT-NIR光谱仪可以配备光纤探针,以直接分析其容器中的原材料。bob综合游戏完整的身份证软件可以指导用户通过库创建过程,并在加载码头上提供单击标识。这matrix-fsystem comes with a NEMA rated enclosure enabling it to withstand the toughest plant environments.

Incoming goods inspection and quality control usingFT-IR spectroscopy主要使用所谓的ATR(衰减总反射)技术进行。它允许在几秒钟内测量几乎所有类型的液体,固体和糊状样品的IR光谱。对于身份控制,将样品光谱与参考物质的光谱进行比较。

对对的需求不断增长便携式拉曼systems for material verification is constituted in the vast capabilities of this spectroscopic technique. High selective information content and no need for sample preparation combined with the capability to probe materials directly through transparent packaging material often make Raman spectroscopy as the method of choice.

布鲁克developed theBRAVOto overcome the limitations of handheld Raman spectroscopy like fluorescence or safety issues. As a class 1 laser product, BRAVO combines maximum user safety with the utmost ease of use, of course fully compliant to regulations like CFR 21 Part 11. BRAVO is the dedicated solution for material verification in the pharmaceutical industry.

NMR另一方面,作为一种结构丰富的技术并固有的定量,在同一实验中测试原材料的身份及其定量的优点,可能需要少于1分钟。bob综合游戏应该杂质可以检测到,NMR和MS是阐明未知的选择,提供信息或无信息。

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