Process & Quality Control of Pharmaceutical Compounds using EDXRF Spectrophotometer

10 Mar 2017
Mia Harley
Biochemist

Industry news

The S2 PUMA energy dispersive X-ray fluorescence spectrometer (EDXRF) now comes with the 21 CFR Part 11-compliant software package enabling users to integrate the instrument seamlessly into pharmaceutical laboratory environments for process and quality control.

Applications include the analysis of active pharmaceutical ingredients (APIs), product safety measures such as the quantification of inorganic impurities, and the analysis of residual compounds from metallic process catalysts.

The new software guarantees complete data integrity and authenticity with features such as electronic record keeping, electronic signatures, and automatic audit trails. The complementing instrument qualification and operational qualification package (IQ/OQ) further supports users in the pharmaceutical industry.

Based on its HighSenseTM technology, the S2 PUMA easily performs the identification and analysis of hazardous toxic trace elements and contaminants from production processes according to Pharmacopeia regulation. No matter if samples are presented as pressed pellets or in powder form, the instrument can be configured for measurements in vacuum or under helium to perfectly suit any application.

Especially in combination with the TouchControlTM interface and its unique ease-of-use for failsafe operation, the S2 PUMA becomes a vital tool for the pharmaceutical industry.

For higher workloads the compact benchtop instrument is available with an exclusive 20 position sample tray and an automatic sample grabber. The S2 PUMA is also available for integration into automated laboratory environments.

EDXRF is a reliable technology used worldwide in many industrial quality control applications and stands for high analytical accuracy and precision, simple sample preparation, fast analysis-to-results times, easy instrument operation, and lowest cost of ownership. The S2 PUMA combines all of this into one high-performing instrument.

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Process ChemistryProcess chemistry is an important stage of drug development for scaling-up drug production or chemical synthesis reactions. It is useful for optimizing economical and efficient drug production. Process chemistry uses reactors and pump systems as well as reagents, standards and buffers.X-Ray Diffraction and SpectroscopyX-Ray diffraction & spectroscopy are used in material characterization to discern the structure and elemental composition of a sample. X-Ray diffractometers (XRD) are superior instruments in elucidating the dimensional atomic structure of crystalline materials, including powders, thin films and single crystals. For large unit cells or ordered macromolecules, consider small-angle X-ray scattering (SAXS). X-ray spectroscopic techniques include X-ray fluorescence (XRF) and X-ray photoelectron spectroscopy (XPS), both providing simple and accurate methods for determining the elemental composition of a material. Energy dispersive (EDXRF) and wavelength dispersive (WDXRF) XRF spectrometers are available, as well as handheld/portable devices. High-resolution, 3D microstructure characterization of materials can be achieved with X-ray microscopes combining sub-micron resolution imaging with 3D computed tomography. Find the best XRD and XRF spectrometers in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. X-Ray FluorescenceX-ray fluorescence (XRF) is an analytical technique used to determine the elemental composition of materials. It is widely used in geology, materials science, and environmental testing for detecting heavy metals and other elements. Browse our peer-reviewed product directory to find the best XRF systems, compare products, check reviews, and get pricing directly from manufacturers.Active PharmaceuticalsThe Active Pharmaceutical Ingredient (API) of a drug is the component that causes the direct effect of the product. The remaining inactive components are known as excipients.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.
Process & Quality Control of Pharmaceutical Compounds using EDXRF Spectrophotometer