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Method Development and Validation

Validation of an analytical procedure is an essential process in the GMP analysis of a pharmaceutical product.  This can include Limit tests for the control of impurities and  quantitative tests of the active in drug products.  Validation parameters as set out by the International Committee on Harmonisation (ICH) are followed.

 

Assay, Impurity and Stability Indicating methods utilizing techniques such as  HPLC, LC/MS, GC, GC/MS, ICP/OES, ICP/MS and Ion Chromatography are available.

 

Method Development & Validation for:

·          Assay and Related Substances 

·          Dissolution

·          Characterization of impurities and unknowns (Qualitative and quantitative)

 

 

 


Activation Laboratories Ltd. | 41 Bittern Street, Ancaster, Ontario, L9G 4V5, Canada | TF: +1.888.228.5227
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