32 CHROMATOGRAPHY/SPECTROSCOPY
Simplify analysis with X-ray fluorescence spectroscopy
Ian Campbell looks at the advantages of X-ray fluorescence spectroscopy.
C
haracterisation of pharmaceutical compounds and the analysis of complex modern formulations, together with an increasing need for data to support regulatory submissions, means that the pharmaceutical industry now depends on a range of analysis technologies. XRF fluorescence spectroscopy is a non-destructive technique used to identify and determine the concentrations of elements present in solid, powdered and liquid samples. XRF is capable of measuring elements from Beryllium
(Be) to Uranium (U) and beyond at trace levels and up to 100 per cent. It requires simple or even no sample
preparation.It detects and quantifies major and minor elements in fillers, lubricants, coatings and other excipients down to sub-ppm levels. XRF can also be applied to the high precision quantification of catalyst residues present in active ingredients or final drug products.
Regulations
The pharmaceutical industry is heavily regulated beyond all other industries. This is for a good reason because many of the materials produced are potentially dangerous and can be severely toxic if not manufactured with proper care. Regulation has led to the
mandatory examination of all substances from starting materials to finished products. Generally this includes the proof
of product stability, drug-release profiles, Active-Pharmaceutical- Ingredient (API) form, API quantification, and product safety including sterility (for non-biological materials) and foreign materials including heavy-metals. PANalytical has a
range of systems for X-ray analysis within the pharmaceutical industry. All are designed to meet
regulatory requirements, including suitability
Fig. 1. The MiniPal 4 Pharma.
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for use in a 21 CFR Part 11 compliant laboratory environment.
Tailored needs
MiniPal 4 Pharma is the latest in PANalytical’s line of compact, benchtop energy dispersive X-ray fluorescence (EDXRF) spectrometers. It is tailored to the specific needs of the pharmaceutical industry and provides a robust, reliable and cost-effective method of analysis. The easy-to-use MiniPal4 Pharma is designed for the
accurate and precise analysis of pharmaceuticals active ingredients, excipients, and identification of general use materials (GUMs). Example applications include elemental analysis for the detection of residual catalyst and residue from the manufacturing process, such as stainless steel. Designed to outperform the requirements of international standards, MiniPal 4 Pharma meets protocols for validating analytical instruments and is configured to support FDA 21 CFR Part 11 regulations. It offers the possibility of working in conjunction with many established LIMS systems. MiniPal 4 Pharma is configured for FDA 21 CFR Part
11 compliance and offers accurate and precise analysis of pharmaceutical active ingredients and excipients, and the identification of general use materials. Like all MiniPal systems, it is easy to use and is a robust, reliable and cost-effective solution for on-site quality control. Best of all it eliminates the need for time-consuming sample preparation.
elements from sodium to uranium, in concentrations from 100 per cent down
M
to µg/g levels and offers high levels of sensitivity and versatility. Featuring a new Silicon Drift Detector, with currently the best resolution in this market segment, it demonstrates high maximum count rates and an excellent resolution, improving accuracy, precision and lower limits of detection. It is one of the
smallest full-function spectrometers currently
➠
iniPal 4 Pharma performs
nondestructive analysis of
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