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LoginWith more than 25 years of experience in analytical testing of drug products and as part of clinical and pre-clinical studies, ALS in Luleå, Sweden has developed and validated over 350 analytical methods for determining metals and elemental impurities in pharma products for our clients. Bioanalytical method validation and testing capabilities include:
Robust contamination control, thorough remediation strategies and method development allows measurements of a wide ranges in concentrations. This is of particular importance in, for example, pharmacokinetics studies where concentrations can vary from low ppt to percentage levels.
Adherence to ICH Guideline M10 in the method validation stage will ensure the quality of bioanalytical laboratory data in support for development and market approval of drug products. Laboratory analysis of biological matrices is an important aspect in the assessment of the safety and efficacy of drug products that are under development. As such, method validations are crucial in order to establish that the testing method used is suitable for the intended purpose.
Our bioanalytical operations by ICP undergo all validation steps to ensure that each test meets the relevant validation parameters. Quality is at our core and the laboratory complies with numerous international regulatory standards:
The laboratory in Luleå, Sweden is custom built for high-quality trace metal and ultra-trace elements determination. By operating the most sensitive analytical instrumentation (ICP-SFMS) in a controlled environment with controlled air flow and temperature, ALS offers trace- and ultra-trace element testing with LOQs matched by few labs worldwide. We have validated and accredited analytical methods for determining 67 elements in:
We offer analytical solutions for measuring 20+ isotopic systems including stable isotopes (e.g. Fe, Cu, Zn, Mo) in biological matrices. Moreover, ALS offers analysis of inorganic arsenic and selenium, methylmercury as well as organotin compounds in biological samples.
Our comprehensive instrumental park allows us to dedicate certain instruments to different sample types. This allows us to ensure optimal analytical calibrations as well as the ability to offer the lowest possible LOQs. It also ensures a solid backup capacity for our clients.
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