Intertek Pharmaceutical Services
P.O. Box 470
291 Route 22 East
Salem Industrial Park, Bldg #5
Whitehouse, NJ 08888
T: (908) 534-4445, ext. 669
E: intertek.whitehouse@intertek.com
W: https://www.intertek.com/pharmaceutical/analysis/whitehouse-nj/

 

Intertek’s Pharmaceutical Services laboratory in Whitehouse, NJ, is an FDA- and DEA-registered cGMP-compliant facility, specializing in complex and routine services to support the development of drug products, formulations, medical devices, and drug delivery systems for clients globally. We have pharmaceutical expertise for various GMP and CMC testing, including method development and validation, stability, extractables and leachables, and elemental impurities.

Partnering with our Whitehouse facility brings the assurance, confidence, and peace of mind that comes with collaborating with a current good manufacturing practice (cGMP) compliant facility, ensuring that testing will be carried out to the most up-to-date and highest quality standards, preserving the integrity of your products.

COMPANY OVERVIEW

For more than 130 years, companies around the world have depended on Intertek to help ensure the quality and safety of their products, processes and systems. We go beyond testing, inspecting, and certifying products; we are a Total Quality Assurance provider to industries worldwide. Through our global network of state-of-the-art facilities and industry-leading technical expertise, we provide innovative and bespoke Assurance, Testing, Inspection, and Certification services to customers. We provide a systemic approach to supporting our customers’ Quality Assurance efforts in each of the areas of their operations, including R&D, raw materials sourcing, components suppliers, manufacturing, transportation, distribution, and retail channels, and consumer management.

SERVICES OFFERED

Analytical Method Development and Validation
Supporting drug development delivering regulatory-driven and phase-appropriate methodology across a range of analytical technologies

Elemental Analysis and Trace Metals
Supporting pharmaceutical development and GMP production through elemental composition and impurity quantification testing services

Elemental Impurities
United States Pharmacopeia (USP) <232> and <233> elemental impurities testing in drug products including screening and quantification of potentially toxic metal impurities

Extractables and Leachables
Quantification and assessment of risks associated with potential leachable impurities that originate from pharmaceutical container closures, process equipment and medical device packaging

Stability Studies
Supporting drug product development, commercial stability studies, batch release and quality control testing

Quality Control
Release testing of raw materials, excipients, APIs and intermediates to pharmacopoeia specifications supported by troubleshooting and specialist QC methods

Medical Device Testing
Analysis to ensure materials comply with strict industry specifications to meet application performance requirements for intended use in industry

Nitrosamine Impurity Testing & Analysis
N-nitrosodimethylamine (NDMA) in API and final drug products by LC-MS/MS, GC-MS and GC-MS/MS Methods


WHITE PAPERS

Extractables & Leachables

Extractables and Leachables Testing: An Introduction and Strategies in Current Practice

Trace Analytical Methods and Techniques for Testing Extractables and Leachables

Importance of a High Performing GC-MS Based Screening Method for Testing Stability Samples for Volatile and Semi-Volatile Leachable Impurities

Analyzing Leachables from Plastics

Elemental Impurities

Elemental Impurities: A Guide to Risk Assessment and Testing

Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products

Stability & Pharmaceutical Testing

Outsourcing Stability Studies to Contract Laboratories: Keys to Success

VIDEOS

Intertek Pharmaceutical Services

BLOG

https://www.intertek.com/blog/med-pharma/