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

Analytical R&D and Quality Control

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

Upgrades
UPLC/High Resolution MS (Thermo Orbitrap Elite Velos/Waters Accurity)
Agilent 7890a GC 5975c MS
KF Metrohm 851
Vaisala Data Logger
Agilent GC/Headspace/ Direct Injection (7890B/7697A)
Agilent UPLC/MS Infinity II /G6135B
Agilent GC/MS (7820A GC/5977B MSD)