Comprehensive Extractables & Leachables Testing

Extractables and Leachables Testing

• Product Development Support
• Quality Control Assurance
• Regulatory Approval Assistance

Industries We Serve:

• Pharmaceuticals
• Medical Devices
• Food Products
• Cosmetics
• Packaging

Our Expertise:

• Custom-designed simulated conditions
• State-of-the-art analytical techniques
• Time-based elution rate studies

Analysis Methods:

• UHPLC-UV-ELSD-QTOF-MS
• GC-MS & HS-GC-MS
• HPLC & UV-Vis
• FTIR & TOCWhy Choose Us?
• 25+ Years of Experience
• PhD-Level Scientists
• Regulatory-Ready Reports

We adhere to relevant standards including ASTM, USP, and ISO guidelines:

• ASTM D1045 Standard Test Methods for Sampling and Testing Plasticizers Used in Plastics
• ASTM D7823 Test Method for Determination of Low Level, Regulated Phthalates in Poly (Vinyl Chloride) Plastics by Thermal Desorption — Gas Chromatography/Mass Chromatography
• ASTM WK43975 New Practice for Determining and Characterizing Extractables from Materials Used in Single-use Applications
• USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
• USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery Systems
• ISO 10993-12 Sample Preparation and Reference Materials
• ISO 10993-18:20 Chemical Characterization of Medical Device Materials Within a Risk Management Process

Don’t risk product safety or regulatory non-compliance. Get expert extractables and leachables testing from CPG.

Contact us today for a consultation and discover how our expertise can ensure your product’s safety and market success.

ISO 17025 Accredited #3930.01

ISO 9001 Certified #000912-1-US-1-QMS

FDA Registered #3005793482