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Analytical services to the pharmaceutical industry
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ALS Scandinavia offers specialized services to the pharmaceutical industry, applying both to drug development and to quality control of products. Our services range from single determinations to larger projects involving bespoke method development with validation protocols defined together with the customer. We especially emphasize cooperation with the customer and thorough discussion of analytical tasks. Even for small contracts the laboratory provides advice on sample handling, suitable sampling kits and containers, etc.
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TRACE ELEMENTS
Due to their interactions with biomolecules, trace metals attract increasing interest in the pharmaceutical field. As examples, APIs may need to be checked for contamination from precious metal catalysts, and finished products for impurities present in excipients or introduced in the manufacturing process.
CLINICAL STUDIES
ALS Scandinavia has developed analytical methods for a wide range of trace elements in biological materials, in part together with the Luleå University of Technology. This work is widely recognized in the scientific community and is reflected in a number of publications The methods are well suited for clinical studies.
See also
www.human-analysis.com.
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TECHNIQUES
ALS Scandinavias in-house analytical capabilities are focussed on:
elemental analyses by atomic spectrometry, down to ppt or ppq levels
particle analyses by SEM (scanning electron microscopy)
Spectrometry techniques permit determination of very low concentrations. The lower the detection limit, the smaller the sample amount necessary for an analysis. This is especially important for API:s and certain human biological materials.
The technique also enables the use of stable isotopes as non-radioactive tracers for both in vivo and in vitro studies.
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SEM (scanning electron microscopy) is frequently used to identify single particles occuring as impurities in raw materials or products. The method is widely used to trace impurities in finished products to the specific production stage where they were added. SEM is a rapid and accurate tool for solving the complex analytical problems often arising in large production facilities.
ALS Scandinavia's purpose-built laboratory provides the clean-room environment necessary to fully utilize the extreme detection capacity of the instruments. The laboratory also has an in-house production of suprapure water and acid using sub-boiling distillation.
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SCREENING ANALYSIS
Trace elements studies are often unspecific with regard to which elements are of interest. In such cases, i.a., a screening analysis may be appropriate. It provides rapid information about which elements are detected and an estimation of their respective concentrations. More than 70 elements are measured simultaneously. The accuracy and sensitivity of the analyses are high, while the cost is relatively low.
PHARMACOPOEIA ANALYSIS
ALS Scandinavia also performs analyses of raw materials, intermediates, APIs, excipients and finished products. Pharmacopoeia analyses are performed according to European Pharmacopoeia and United States Pharmacopoeia (USP). We also use certain customer-specific and in-house developed methods in our broad range of organic analyses, based on GC and LC in combination with mass spectrometry.
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VALIDATIONS
As a subcontractor, we fulfil our clients requirements regarding GMP, ICH validations of methods and confidential treatment of information. We routinely take part in audits from pharmaceutical companies and in national and international comparison programs. Working entirely on a contract basis, ALS Scandinavia is experienced in services with requirements for efficiency and adherence to deadlines. The large number of instruments, together with a well-developed laboratory infrastructure, create the conditions necessary for high productivity and safety in delivery of results. |
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