Raw Materials Analysis

Impurities and adulterants in raw materials pose potential health threats when present in the manufacturing of pharmaceutical APIs and drug products. These same impurities and adulterants may also result in lower production yields and greater needs for product purification. Thus, their identification and quantification within incoming raw material play an important role in the pharma industry, ensuring product safety & quality, and an overall smooth and cost-efficient manufacturing process.

Bruker offers a complete portfolio of analytical systems for quick and accurate identification of raw materials.

X-ray fluorescence (XRF) is a reliable, precise, and accurate technique with the potential to analyze inorganic impurities at ppm or even sub-ppm level in many types of raw materials used in the pharma industry. XRF is also ideal for quick identification of certain substances, such as the differentiation of KCl and NaCl. Modern high-end laboratory energy-dispersiveXRF光谱仪allow for high throughput, are easy to operate, and comply with applicable data management regulations (e.g. 21 CFR Part 11). Portable XRF units can be used for a quick assessment of a new delivery upon arrival.

Key advantages of XRF compared to more classical wet chemical techniques are the fast and simple sample preparation, the ease-of-use, and the low operation costs (no toxic/expensive chemicals/gases required!

XRD独特地直接以固体形式探测原子和分子排列。因此，X射线粉末衍射可以通过指纹进行晶体和无定形API，赋形剂和其他任何材料的检测，鉴定和定量。bob综合游戏可以快速bob综合游戏筛选原材料以控制纯度，结晶度和多态性以及混合物中的绝对相丰度。

FT-NIR spectroscopyvia fiber optic probes is rapidly becoming a standard method of accomplishing this crucial material validation, providing unprecedented speed and flexibility for the identification of both solid materials and liquids.

两个都MPAII和MATRIX-FFT-NIR spectrometers can be equipped with fiber optic probes for direct analysis of raw materials in their containers. Complete identification software guides the user through the library creation process and provides single-click identification even at the loading dock. TheMATRIX-F系统带有NEMA额外的外壳，使其能够承受最艰难的植物环境。

使用的商品检查和质量控制使用FT-IR光谱法are mainly performed using the so-called ATR (Attenuated Total Reflection) technique. It allows measuring IR spectra of almost all types of liquid, solid, and paste-like samples within some seconds. For identity control, the sample spectrum is compared against the spectrum of a reference substance.

The growing demand forportable Raman实质性验证的系统在这种光谱技术的巨大功能中构成。高选择性信息含量，不需要样品制备以及通过透明包装材料直接探测材料的能力通常会使拉曼光谱作为选择方法。bob综合游戏

布鲁克开发了布拉沃to overcome the limitations of handheld Raman spectroscopy like fluorescence or safety issues. As a class 1M 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 lab in your hands for material verification in the pharmaceutical industry.

NMRon the other hand, being a structural rich technique and inherently quantitative, offers the advantage of testing the identity of raw materials and their quantification in the same experiment, which can take less than 1 minute. Shouldimpuritiesbe detected, NMR and MS are the techniques of choice to elucidate the unknows, providing go- or no-go information.