Organic Synthesis : Scale-up Chemistry : cGMP : Contract Manufacturing Toronto : Analytical Services : Complex Molecule R&D : Alphora Research Inc.

Analytical Development

Alphora pays particular attention to the increased analytical and regulatory requirements
of API technology development; as well for scientific and technical purposes.

Our analytical capabilities are comprehensive in this respect and our labs have been
outfitted with considerable instrumentation.

Analytical development services include:

Method Development
Method Validation
API Characterization and Impurity Control
Genotoxic Impurity Controls
Pharmaceutical Specification Development
Method Transfer

Equipment:

8 Agilent 1100/1200 HPLC's with diode array and variable wavelength detection
5 Agilent 1200 Rapid Resolution LC's with diode array detection.
5 Waters 2695 HPLC's with diode array, variable wavelength and ELSD detection.
1 Waters Acuity H-Class QbD Method Development UPLC system
5 Agilent 6890N/7890A GC's with FID and TCD detection, 3 with Headspace Autosamplers

1 Agilent 7890A/5975C GCMS System with Headspace Autosampler - GMP

1 Dionex ICS 3000 Ion Chromatograph (both Anion and Cation)

1 Bruker microTOF focus LCMS (Accurate mass capability) - GMP

FTIR

UV Spectrophotometer

Polarimeter

Volumetric and Coulometric Karl Fisher Titrators

Multi purpose potentiometric titrator

TA Instruments Q200 DSC System

TA Instruments Q5000IR TGA System

ICP testing available through local contract laboratory through CDA

Single Crystal and Powder X-ray Diffraction available through local university under CDA