Expertise in method development and validation, stability, trace organics, elemental impurities, and QC testing for more than 30 years
Intertek Pharmaceutical Services, located in Whitehouse, New Jersey, USA, is a contract consulting analytical research and development laboratory and Good Manufacturing Practice (cGMP) compliant facility. We specialize in method development and validation, stability, trace organics, elemental impurities, and quality control testing. We provide complex and routine services to support the development of drug products, formulations, devices, and drug delivery systems for pharmaceutical and biotechnology companies.
Our Discovery Support Department is one of the nation’s largest providers of trace metals and organic elemental analysis. Our facility provides routine support to researchers throughout the entire pharmaceutical and chemical industries, as well as academic institutions using in-house methods developed for informational purposes. Any method may be validated to meet compound specific and client regulatory requirements. We also specialize in compound characterization, reference standard support, identification and quantitation of inorganic components, toxicology screening, product profiling, determining contaminants related to packaging materials, residue characterization and compendial testing.
Supports drug development across a range of analytical technologies
Supports pharmaceutical development and GMP production
USP <232> and <233> elemental impurities testing
Quantify and assess risk associated with potential leachable impurities
Supports drug development, commercial stability studies, batch release and QC testing
Release testing of raw materials, excipients, APIs and finished pharma products
Upcoming industry events and conferences
Publications, Webinars, Blogs and Scientific Posters
Learn more about our scientific team
Intertek Pharmaceutical Services
P.O. Box 470
291 Route 22 East
Salem Industrial Park
Whitehouse, NJ 08888
USA
Sample Size and Pricing Guide (PDF)
Download our Pharmaceutical Testing brochure (PDF)
Download our Intertek Pharmaceutical Services Brochure
Download our Custom Extractables and Leachables Solutions Brochure
White Paper: Rapid Determination of Benzene in Pharmaceuticals
White Paper: Trace Analytical Methods and Techniques for Testing E&L
Related Links
Client Notification
We are happy to announce the roll out of our Agilent OpenLab Chromatography Data System (CDS) at the Intertek Whitehouse facility. Read More
Wheel of Pharmaceutical Services - Whitehouse, NJ
Interview with Scientific Liaison, Gyorgy Vas
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Interview with Laboratory Manager, Mike Murphy
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Recorded Webinars
- NEW: Regulatory Driven E and L Studies for Key Drug Delivery Formats
- Design of Robust and Sensitive Extractables and Leachables Studies
- Extractables and Leachables Studies on Process Materials and Container Closure Systems
- Biocompatibility - The Importance of Extractables & Leachables Testing
Whitepapers
- NEW: Risk-Based E&L Strategies for Bioprocessing Single-Use Systems
- From Extractables to Leachables: Problem Solving for Complicated Formulations and Container Closure Systems
- Evaluation of Extraction Conditions for Volatile Extractables
- Extractables and Leachables Strategies for Pharmaceutical Production Tubing
- Importance of a High Performing GC-MS Screening for Testing Stability Samples for Volatile and Semi-Volatile Leachable Impurities
- Impact of the GC-MS Injection Solvent and the Analyte Concentration on Relative Responses for common Extractables
- Extractables and Leachables Strategies for Transdermal Patch Products
- Trace Analytical Methods and Techniques for Testing Extractables and Leachables
Pharmaceutical News & Events
- PRESS RELEASE: Lab expansion to enhance capabilities in inhaled biologics drug development
- PRESS RELEASE: Intertek partners with CrystecPharma to advance formulation science and accelerate development for dry powder inhalers
- NEW! Blog: Optimising Quality in Pharma Supply Chains
- Determination of Particles in Pharmaceuticals - Article
- Discover our Audit Live Tool for direct access to our scheduled audits
- Extractables/Leachables Lab Tour - Request access
- Medical Device Extractables & Leachables Studies
- Glycosylation Analytical Approaches for Antibody Therapeutics
- Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products
