Quality Control

Raw Materials Analysis

传入商品的身份检查

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

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MPAIIMATRIX-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。

The growing demand forportable Raman实质性验证的系统是在这种光谱技术的广泛能力中构成的。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. Should杂质be detected, NMR and MS are the techniques of choice to elucidate the unknows, providing go- or no-go information.

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