Activation Laboratories Ltd. services

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.

R&D Applications: Crystal structure determination by powder X-ray diffraction. Polymorph screening. Patent investigation and comparison.

Pharmacopeial monographs such as the US Pharmacopeia-National Formulary (USP/NF), the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and the British Pharmacopoeia (BP) provide standardized methods and specifications for generic pharmaceutical raw material and finish products.  Certificate of analysis (C of A) for raw material and products are provided.