Demonstrate quality control with our identity, purity, and quality testing of the materials used in your finished product manufacturing. Our experienced team supports vendor qualification and performs testing according to compendial, client-supplied, or vendor-supplied methodology. These raw materials testing services are supported by replicate capacity for optimal turnaround times, streamlined data and document access with our online portal, and late-phase and post-approval change support. We routinely test raw materials according to a variety of industry standards and compendia.
United States Pharmacopoeia/National Formulary (USP/NF)
European Pharmacopoeia (EP)
British Pharmacopoeia (BP)
Japanese Pharmacopoeia (JP)
Japanese Pharmaceutical Excipients (JPE)
Chinese Pharmacopoeia (ChP)
Food Chemical Codex (FCC)
American Chemical Society, Reagent Standards (ACS)
We hold registrations with the FDA and DEA, ensuring regulatory compliance. Our labs are cGMP compliant and ISO/IEC 17025 accredited, enabling us to offer the highest quality control of raw materials.
Our team leverages existing compendial methods, also known as pharmacopeial methods, to ensure your products meet the defined standards before they are released for distribution and consumption. These standardized testing procedures and analytical methods are outlined in official pharmacopoeias and serve as a foundation for quality control, consistency, and regulatory compliance within the pharmaceutical industry. Our team applies these methods based on your instruction to ensure the safety and efficacy of your drug product.
We understand that compendial methods are not always available nor applicable for novel materials and are able to adapt to your unique circumstances. If you have pre-existing methods for your materials, we can transfer them into our laboratories. When appropriate methodology does not exist or is otherwise unavailable, our team develops and completes phase-appropriate validations of custom methods. Custom methods (i.e., Client Laboratory Methods, or CLMs) are owned by the sponsor. Once established within our laboratory, CLMs can be used for routine analyses or transferred to other sites as needed.
USP <467> Residual Solvent Testing
Spectrophotometric Analyses (Fourier-Transform Infrared Spectroscopy [FTIR], Ultraviolet-Visible Spectroscopy [UV/VIS, UV-Vis])
Metals Analyses (Atomic Absorption Spectroscopy (AA), Graphite Furnace Atomic Absorption Spectroscopy (GFAA), Inductively Coupled Plasma with Optical Emission Spectroscopy (ICP-OES), Inductively-Coupled Plasma with Atomic Emission Spectroscopy (ICP-AES), Inductively-Coupled Plasma with Mass Spectroscopy (ICP-MS))
Heavy Metals Testing (ICP-MS)
Ethylene Oxide and 1,4 – Dioxane Testing
Plastics Container Testing per USP <661> and <671>
Purified Water Testing
Karl Fisher (KF) Analyses
Wet Chemistry Analyses
Ready to Get Started? Connect with our team to discuss your testing and development needs.