Quality & Sourcing Standards
Documentation and testing discipline behind every lot
- Manufacturer Vetting - Sourced only from manufacturers able to provide documentation on manufacturing process and quality history
- Purity Testing - Identity and purity verified via HPLC/MS prior to lot release
- Certificate of Analysis - COA provided with every order, available for download on each product page
- Storage and Handling - Cold-chain and storage conditions specified per product and maintained through shipment
- Traceablity - Lot-level documentation maintained for chain-of-custody records
Looking for a specific Certificate of Analysis? COAs are available for download on each product page, or request one directly.
Regulatory and Legal Notices
Who may purchase Products offered through Summit API Group are intended exclusively for qualified research institutions and licensed compounding pharmacies (or their authorized purchasing agents) for lawful research or compounding purposes. By requesting a quote, you represent that you are purchasing in that capacity and hold any licensure required for your intended use.
Sourcing standard We work to source from manufacturers that maintain applicable FDA establishment registration and can provide lot-specific documentation. Buyers remain responsible for independently confirming a given compound’s current regulatory status — including its standing under the applicable 503A or 503B bulk substances framework, USP/NF monograph status, or status as a component of an FDA-approved drug — before use in compounding, as that status can and does change over time.
No medical claims Nothing on this website is intended to diagnose, treat, cure, or prevent any disease, and nothing here should be construed as medical or clinical guidance. Products are not intended for direct human consumption outside of a licensed compounding process conducted in accordance with applicable law, or legitimate research use.
Documentation A Certificate of Analysis (COA) is made available for each product. Product specifications reflect the documentation provided by the sourcing manufacturer at the time of testing.
No warranty beyond documented specifications Products are provided in accordance with the specifications on their accompanying documentation. Summit API Group makes no warranty, express or implied, beyond what is reflected in that documentation.
Licensing Summit API Group is in the process of establishing and expanding the state and federal licensing applicable to its business operations.
