Pharmaceutical Testing
Columbia Analytical is a registered contract testing laboratory providing cGMP-compliant testing to the raw material suppliers, CMOs, and product developers/sponsors of the pharmaceutical industry. To ensure regulatory compliance, Columbia Analytical is FDA inspected and registered and DEA licensed. We maintain a comprehensive quality unit that ensures all data is scientifically sound and accurately documented.
Learn about FDA regulations for dietary supplements...
Monograph Testing
Columbia Analytical utilizes USP/NF, EP, JP, BP, AOAC and ACS compendial methods for raw material and final product testing. Examples include residual solvents USP <467>, microbial limit tests USP <61> and infrared absorption USP <197>. Columbia Analytical also conducts analyses using client supplied methodology after appropriate method transfer protocols.
Method Development and Validation
Our professional scientists have extensive experience in analytical chemistry and routinely provide method development and validation for pharmaceutical testing. Methods are validated to current USP/ICH guidelines.
Engineering Studies/Process Validation
Columbia Analytical's scientists are accustomed to non-routine testing and have the knowledge and resources to solve your analytical problems. Examples of this may include analytical support for cleaning studies or manufacturing processes.
Stability Testing
Columbia Analytical provides analytical support to your stability study testing. This may include assay testing, physical testing, and impurity and degradation product monitoring. Development and validation of stability indicating assays is also available.
Pharmaceutical analysis test request form
Pharmaceutical Instrumentation
Stability Testing (GC)
• Method Development
• Method Validation
• Quantitation
• Direct Injection/Head Space
• FID, MS, MS/MS, TCD
• Product Assay/Impurities Analysis
High Performance Liquid Chromatography (HPLC)
• Method Development
• Method Validation
• Quantitation/Assays
• Impurity/Degradation Stability Analysis
• Ultra-Violet/Visible Detector (UV/Vis)
• Photo Diode Array Detector (PDA)
Liquid Chromatography / Mass Spectrometer (LC/MS/MS)
• Method Development
• Method Validation
• Quantitation
Low Level Metals Analysis
• Inductively Coupled Plasma Atomic Emission Spectrometer (ICP-AES)
• Inductively Coupled Plasma/Mass Spectrometer (ICP/MS)
• Inductively Coupled Plasma/Mass Spectrometer with integrated HPLC (HPLC-ICP/MS)
• Graphite Furnace and Flame Atomic Absorption Spectrometer (GFAA/FAA)
Additional Instrumentation
• Fourier Transfer Infrared Spectrometer (FTIR)
• Karl Fischer Titrator (Volumetric & Coulometric)
• Melting Point Apparatus
• Polarimeter
• Dissolution Apparatus
• Autotitrator
• pH/Conductivity
• Refractometer
• Viscometer/Rheometer
• Incubators
• Vacuum Oven
• UV/Vis Spectrophotometer
Microbial Studies
• Aerobic, E-coli, Salmonella
• Yeast/Mold
