固体形式

多态性描述了以下事实：某些具有相同成分的材料可以以一种以上的晶体形式存在，其特征是不必威手机客户端同的分子堆积。识别，理解和控制材料的多态性形式的能力对多个技术领域很重要，但与药物领域具有特殊相关性。

Most pharmaceutical products are administered as solids (e.g. tablets, capsules and inhalation materials) and the polymorphic form of the Active Pharmaceutical Ingredient (API) is of direct interest because it can influence the dissolution behaviour of the product in-vivo, and therefore the bioavailability.

反过来，API的多态性形式可能会受到处理，配方和存储条件的影响，因此在API合成路线开发，配方开发，存储和制造等期间进行检查通常很重要。

It is possible that an API can exist in multiple different polymorphic forms, and the determination of form or of the combination of forms, in a specific sample can be technologically challenging, especially when there are other important factors affecting the overall picture such as the existence of solvates, hydrates and also amorphous material. Thus, the analytical challenges can be difficult, and multiple methods are typically used across the industry.

四种领先技术（X射线衍射，NMR光谱法，，，，Raman spectroscopyandmiR光谱) are available from Bruker. These techniques are highly complementary and all have the advantages of being well-established, information rich, non-destructive in nature, and requiring only a small amount of sample (10s to 100s of mg) per assay.

X射线衍射技术对于在药物生命周期内的所有阶段表征多态性的表征起着至关重要的作用。X射线粉末衍射（xrd) is widely used for detection and identification (‘finger-printing’) of known and new, previously unknown phases. Once identified, quantitative phase analysis of crystalline as well as amorphous materials can be performed. Both, single crystal X-ray diffraction (SC-XRD）和XRD允许从头开始确定晶体结构。SC-XRD是最明确，最喜欢的技术；最重要的是，它能够确定绝对结构，从而使其成为表征对对照组的选择工具。每当不能生长合适的单晶时，XRD在结构测定中起着至关重要的作用。

Solid-state NMR spectroscopy（SSNMR）是一种出色的补充分析技术，可以表征药物和药物产品的固体形式。SSNMR用于识别不同的晶体和/或无定形形式，以监测API缩放期间的形式转换，检测到其他形式的少量（例如，无定形中的晶体），测量预测物理化学稳定性的松弛时间，并进行守卫知识特性。同样，药物非常适合SSNMR的表征，因为摄取通常不会显着干扰分析，即使在药物中的药物水平较低的情况下也不会显着干扰分析。

时域NMR光谱（TD-NMR）是在存在晶体形式和/或赋形剂存在下定量无定形的理想选择，即使在低水平上存在非晶态时，也具有很高的精度。这是一种非侵入性技术：测量后样品保持完整。样品也可以在自己的容器中测量。TD-NMR具有通常与台式仪器相关的其他优点：易用性，低成本和占地面积小。

Raman spectroscopy实现多晶型物之间的快速和可靠的差异化，因此被广泛用于表征固体形式的材料。必威手机客户端诸如平板电脑之类的产品可以通过Raman microscopy and imaging，，，，allowing the determination of the spatial distribution of a specific polymorph, as well as the identification of contaminants. The technique can also be used to study the transformation between different polymorphic forms, when exposed to high temperature or pressure. Furthermore, handheld instruments and high throughput (HTS) options offer powerful solutions for routine quality control.

miR光谱是常规方法来确定化学物质,在哪里as in Far Infrared (FIR) spectral range back bone vibrations in crystal lattices are detected for polymorph differentiation. Bruker’sintelligent FTIR spectrometers与独特FM technologyoffers the measurement of the complete FIR-MIR spectral range in one step and allows for simultaneous identification and polymorph screening of samples. Combined with modern diamond attenuated total reflection ATR accessories the substance can be directly analyzed without any sample preparation, simplifying the daily work in pharmaceutical R&D and manufacturing.