Analytical R&D and Quality Control

Analytical Services

Our analytical team provides all of the analytical needs for process development, GLP studies, and GMP manufacturing campaigns. Our analytical team works closely with our process chemists and engineers, to ensure the success of each project.

Our services include, but are not limited to, method development, method verification / validation, reference standard certification, release testing, stability studies, and impurity separation and identification. We are skilled at HPLC and GC method development and validation; structure elucidation using LC-MS, GC-MS, High Resolution-MS, NMR; stability studies; and solid state / form characterization and solubility and MSZW (meta-stable zone width) determination.

Services include:

HPLC / GC method development for challenging separations including chiral separations

Method development and testing using LC/MS LC/CAD GC/FID GC/MS NMR TGA KF DSC FT-IR Polarimeter

Method transfer/validation

Reference standard certification

Separation and Characterization of impurities and degradants

cGMP release testing

cGMP raw material release testing

cGMP intermediate and API release testing

Stability studies: stability indicating method development and stability sample testing

Genotoxic impurity method development and testing

Forced Degradation Pathway Understanding

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Analytical Equipment

Instruments Qualified / Calibrated for GMP Use

Agilent 1100 LC – UV systems

Agilent 1260 LC – UV systems

Thermo Dionex Ultimate 3000 HPLC / CAD & UV

Thermo SP 3000 HPLC ELSD / UV

Thermo Finnigan Surveyor MSQ Plus Mass Spectrometer

Agilent 6890 GC /FID with headspace and direct injection

Nicolet Avatar 360 FT-IR Spectrometer

OptiMelt Automated Melting Point

Metrohm 756 KF Coulometer with sample oven

Accumet XL-15 pH Meter

Mettler Toledo Micro-balance MT5

PerkinElmer 341 Polarimeter

5 Stability Chambers as being set up at the following conditions: 5°C • 25°C/60% RH • 30°C/65% RH • 40°C/75% RH

Photostability Chamber

Instruments for R&D

Varian Inova NMR Systems 300 and 400 MHz

Thermo Finnigan Surveyor MSQ Plus Mass Spectrometer

Thermo Ultimate 3000 HPLC CAD / UV

Agilent 6890 GC-MS

Agilent 5890 GC-FID systems

Melting Point Apparatus

Thermo SP 3000 HPLC-UV systems one with CAD / UV

Dionex Ion Chromatography

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