ALS Scandinavia’s custom-built laboratory in Luleå, Sweden is dedicated to trace element analyses and our personnel have nearly thirty years of experience working with the ICP technique. As one of the first commercial laboratories in the world, we invested in our first ICP-SFMS in 1996. Today, our instrument park includes 10 ICP-SFMS instruments of which one is completely dedicated to services for the pharmaceutical industry. All analyses are performed in a clean room environment with controlled air and temperature. Not only does this allow us to report high-quality results at very low concentrations - it also ensures a solid backup capacity that enables us to deliver results on time.
To date, ALS Scandinavia has performed more than 80 client specific method validations for the pharmaceutical industry. We offer our clients rapid and cost effective method developments and validations according to:
- US Pharmacopeia (USP)
- European Pharmacopeia (Ph.Eur.)
- ICH Guidelines
All the steps included in a method validation are performed in close collaboration with our customers, typically as follows:
- The analytical method is either proposed by our customer or developed by ALS Scandinavia.
- A validation plan is elaborated by ALS Scandinavia including all the steps for ensuring compliance with the requested pharmacopeia/guidelines, e.g. specificity, detection- and quantification limits, accuracy, range, precision, linearity. This is reviewed and approved by the customer before any validation work is initiated.
- The method validation is then performed as agreed between ALS Scandinavia and the customer.
- Finally, the validation report is prepared and sent to the customer for review and approval.
For more information, please contact ALS Scandinavia.