Impurities Testing for Pharmaceutical Products and APIs
Eurofins BioPharma Product Testing network of laboratories offers comprehensive support for impurities testing and contaminant investigations-from residual solvents and process-related impurities to extractables/leachables and degradant related issues. And with complementary expertise in method development, method validation and stability testing, our biopharmaceutical testing team is the perfect partner to provide corrective action follow-up support.
Why Choose Eurofins BioPharma Product Testing?
- Our scientists are experts at identifying and quantifying very low levels of impurities in the most difficult of sample matrices.
- We have decades of experience working with active pharmaceutical ingredients and drug product, across all major dosage forms and delivery systems, including unit dose vials (UDVs) and metered dose inhalers (MDIs).
- If you have a short-term or infrequent need for testing, our self-validating method approach for residual solvents testing is a faster and more cost effective option.
- We can help determine the most suitable strategies for monitoring impurities and accelerating your drug development programs.
- Our 30-year history of cGMP regulatory compliance ensures that you get the highest quality data.
Testing Available
Residual Solvents/Impurities
- USP <467> and Ph. EUR Method 2.4.24 (all classes of residual solvents in current chapter)
- Customized method development/validation
- Extractables/Leachables
- Controlled extraction studies
- Simulation studies
- Leachable method development, validation & monitoring
- Validation of disposables for use in Biomanufacturing
- Customized method development/validation
Specific example of methods include:
- Establishment of methods for residual solvents using either GC or HPLC
- Leachable methods for process intermediates or final formulations
- Trace metals by Inductively Coupled Plasma in drug products
Process Impurities
- Customized method development/validation
- HPLC product and API specific methodology
- Qualitative/Quantitative analysis
- Tracking/trending of resulting stability studies
Degradation Products
- Customized method development/validation
- Forced degradation studies and assessment of peak purity
- Finished product and API specific methodology
- Qualitative/Quantitative analysis
- Tracking/trending of resulting stability studies
Trace Metals
- Qualitative/Quantitative limits testing (using ICP and ICP/MS approaches)
Elemental Analysis
- Qualitative/Quantitative limits testing (using AA and CHN approaches)
Peak Identification
- Identification of organic compounds using modern mass spectrometry
Instrumentation
Mass Spectrometers
- Agilent GC/MS and GC/MS/MS
- Agilent LC/MS-Iontrap
- Agilent LC/MS-TOF
- Applied Biosystems Voyager DE PRO MALDI-TOF
- Perkin Elmer Inductively Coupled Plasma ICP/MS
- Thermo ICP/MS
- Thermo Scientific Accela LC/LTQ Orbitrap XL
- Waters Xevo G2 LC-MS/TOF and LC/MS/MS
- Bruker ultrafleXtreme MALDI-TOF/TOF
Chromatography Equipment
- Agilent GCs with either headspace or direct injection sample introduction
- Agilent/Waters/Thermo Scientific HPLC/UHPLC
- Dionex ICS-3000 Ion Chromatograph (IC)
Detectors
- Corona Charged Aerosol (CAD+)
- Electrochemical (ECD)
- Evaporative Light Scattering (ELSD)
- Fluorescence (FL)
- Laser-Induced Fluorescence (LIF)
- Refractive Index (RI)
- Ultraviolet (UV)
- Photodiode Array (PDA)
- Diode Array (DAD)
- Pulsed Amperometric (PAD)
Spectrophotometers
- PE Analyst 800 Flame Atomic Absorption Spectrometer
- PE Analyst 400 Flame Atomic Absorption Spectrometer
- PE CHN Analyzer
- PE Graphite Furnace Atomic Absorption Spectrometer
- Thermo iCE3500 Flame/Furnace Atomic Absorption
