Epsilon 4 Pharmaceuticals & Cosmetics
Trust your product quality
The Epsilon 4
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Universal and reliable device.
Sources and product quality control
Excellent results and very simple service. Service and assistance in developing new applications is available.
Review Date: 21 Jun 2019 | Malvern Panalytical
Manufacturer's Response
It is great to hear that the Epsilon gives you excellent results. Thanks for your positive review.
Trust your product quality
The Epsilon 4, an energy dispersive X-ray fluorescence (EDXRF) benchtop spectrometer, offers non-destructive elemental analyses of impurities in active pharmaceutical ingredients and excipients in line with the recommendations in ICH Q3D, USP<232>, USP<233> and USP<735>. Applications that have traditionally been performed by ICP and AAS are now possible without the need for time-consuming and costly sample preparation.
Low running costs
Epsilon 4 does not require the use of expensive acids, gasses and fume hoods, like in ICP and AAS. The only requirement is mains electricity and in some cases the use of helium to boost the sensitivity for light elements in the sample. Also, the individual components in XRF spectrometers are not exposed to friction or heat and therefore last for many years.
Non-destructive analysis
Measurements with Epsilon 4 are carried out directly on loose powders or end products, like pills and capsules, with little to no sample preparation. Since XRF is a non-destructive technique, the sample can also be measured subsequently by other analytical techniques, if required.
IQ and OQ documentation
Installation qualification and operation qualification procedures are available for Epsilon 4. These procedures are instrument verification and validation procedures required by companies to meet good laboratory practice (GLP), good manufacturing practice (GMP) and FDA 21 CFR Part 11 regulations.
Pharmaceutical setup samples
To comply with regulatory requirements, Malvern Panalytical offers a range of cellulose-based system setup samples for toxic elements, catalyst residues or PGM particles in the groups 1, 2A, 2B and 3. The standards contain 17 elements with concentrations ranging from 0 to 200 mg/kg. The three separate sets contain 5 different standards plus a validation sample.
Fast and sensitive
Fast measurements are achieved by using the latest silicon drift detector technology that produces significantly higher intensities.
Unique detector electronics enable a linear count rate capacity to over 1,500,000 cps (at 50% dead time) and a count rate independent resolution typically better than 135 eV for better separation of analytical lines in the spectrum. This allows the Epsilon 4 spectrometer to run at full power and therefore realizes a much higher sample throughput compared to traditional EDXRF benchtop instruments.
Brochures
Epsilon 4 brochure
This product brochure introduces the Epsilon 4 by Malvern Panalytical and it's application in pharmaceuticals and cosmetics.
Achieving Pharmaceutical Challenges with Powder X-ray Diffraction (PXRD)
The pharmaceutical industry demands the highest standards and absolute assurance in quality. As such, selecting the correct equipment to test products is crucial. This white paper explores how modern PXRD instruments assist researchers and manufacturers to meet the relevant regulations and quality standards for pharmaceuticals.
7 Key factors to Consider When Buying a New Benchtop X-Ray Diffractometer
When the time comes to replace or buy a new X-ray diffractometer for your lab, there are a number of key factors you should consider to help you select the best possible system for your requirements. This whitepaper presents 7 factors to help you make this decision decision.
XRD Systems - Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness
This whitepaper describes how Malvern PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the USA FDA. Malvern PANalytical offers tools and services to guarantee authenticity, integrity and confidentiality of electronic records and electronic signatures.
EDXRF for Pharmaceutical Material Elemental Analysis
One of the most common safety related analytical tests is the quantification of inorganic impurities within pharmaceutical products. Many active pharmaceutical ingredients (APIs) may contain residual metal catalysts. Since there are also many potential sources of contamination, it is valuable to measure raw materials, intermediates and final products. This study demonstrates that the X-ray Fluorescence technique is capable of performing elemental analysis of pharmaceutical materials with high sensitivity, precision and accuracy.
