Ensure Your Product’s Quality with Raw Materials Testing
Safeguard your drug product quality from setbacks or repercussions, such as manufacturing delays and recalls, with trusted raw materials data. Our raw materials quality control testing demonstrates the identity, purity, and quality of excipients and active pharmaceutical ingredients used in finished product manufacturing. In addition, our experienced team supports the qualification of your raw material vendors and performs testing according to compendial, client-supplied, or vendor-supplied methodology.
We also offer expedited turnaround time services so that you can count on getting fast, accurate results to meet “just-in-time” manufacturing processes.
Integrated Services To Fit Your Needs
Meet Industry & Compendial Standards
We routinely test raw materials according to a variety of industry standards and compendia.
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.
Raw Materials Laboratory Services
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
Integrated Laboratory Services
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.