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