Material Certification & Qualification

Whether considering which raw material vendor to use or analyzing a finished product on the way to your customer, quality control is critical.

We can help you choose between competing vendors, certify your raw materials, and provide assurance of the quality of your finished products. With our extensive array of techniques and over 165 years of experience, we have the tools to meet your needs.

Examples:

• Molecular weight by GPC, IV, and MFI
• Assay by HPLC, GC-FID, and NMR
• Impurities and additives content by GC-FID, GC-MS, and HPLC
• Thermal characterization by DSC and TGA
• Residual monomer
• Residual solvent
• Heavy metals analysis
• FTIR analysis
• Acid number

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Above: SEC of Poly(Lactide-co-Glycolide), a biodegradable polyester used for resorbable medical implants, and a GC/MS chromatogram identifying Phthalate Ester Plasticizers in PVC

Work We've Done

FDA Material Qualification

PSI can supply the quality needs for your FDA product throughout its life cycle. From analytical support of R&D to qualification of raw materials to routine lot release of a product, we are with you every step of the way.

We can custom-develop methods to suit your analysis needs and validate them to give you the highest assurance of quality.