ALS Scandinavia - Analyses of pharmaceuticals

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USP 232 & 233
The long established method for testing for heavy metals in pharmaceuticals, the colorimetric limit test, is about to become obsolete. Both the USP and the EP have announced their intentions to move from the old test to an instrumental method utilizing modern equipment such as the ICP (Inductively Coupled Plasma) to obtain quantitative results..

tion of metals. The instrument park consisting of nine high-resolution ICP-MS instruments along with several ICP-OES and AFS systems, places ALS at the pinnacle of the best-equipped laboratories globally.

The laboratory has met FDA approval, and is GMP and GLP compliant. Experienced staff has successfully validated more than 70 client-specific methods and will welcome further requests from the industry.

» Read more (pdf).
» For further information, please contact Ms. Katarina Lahti (telephone +46 920 28 99 12)

Analyses of pharmaceuticals
ALS Scandinavia can now, beside trace element determinations, offer several chemical, physicochemical and microbiological analyses, as well as methods according to official pharmacopoeia.

Our services also include development and validation of analytical methods in cooperation with the client.

For further information, please contact Katarina Lahti,
+46 920 28 99 12.

GMP
ALS Scandinavia now complies with the Good Manufacturing Practice requirements referred to in Directive 2003/94/EC.

GMP certificate issued by Swedish Medical Products Agency.

Good Laboratory Practice (GLP) Compliance
In August 2010 ALS Scandinavia in Luleå received “Statement of GLP Compliance” from the Swedish Board for Accreditation and Conformity Assessments. With the GLP compliance statement, ALS now offers clients testing as part of a non-clinical health and environmental safety study. All parts of such a study, including the delegated phase study at ALS, is carried out in accordance with the OECD principles of Good Laboratory Practice. The principles of GLP apply to all safety studies required by regulations for the purpose of registering chemicals, synthetic as well as of natural or of biological origin.

For further information please contact Ms. Katarina Lahti (telephone +46 920 28 99 12).