Ensure your raw materials, drug substance, and drug product meet global standards with our compendial testing services. Compendial standards define the quality, purity, strength, and identity of raw materials and finished products. These standards are established and maintained by authoritative pharmacopeias or compendia organizations, which differ between countries.
Our testing services comply with the requirements described in the most commonly referenced compendia, including:
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 testing services.
To ensure your product consistently meets the highest quality and safety standards, we incorporate three crucial elements – verification, meticulous adherence to compendial procedures, and expertise in interpreting and applying pharmacopeial monograph requirements.
Our testing services include rigorous verification of compendial procedures, ensuring that the methodology used on your materials yields reliable and acceptable results. We verify compliance with established pharmacopeias and regulations, providing you with the assurance that your products meet the most stringent requirements.
We follow compendial procedures meticulously, ensuring that every aspect of testing, from sample preparation to analysis, adheres to the standards set by pharmacopeias. Our commitment to these procedures guarantees that you receive accurate, reliable results.
Pharmacopeial monographs serve as essential references for the identity, purity, strength, and quality of pharmaceutical raw materials and finished products. Our team specializes in helping you navigate regulatory requirements by strictly adhering to the specifications outlined in the applicable compendia and monographs.
Ready to Get Started? Connect with our team to discuss your testing and development needs.