USP <795>, <797>, and <800> compliance requires compounding pharmacies to demonstrate the safety and quality of compounded preparations. Residual solvents, endotoxin, and elemental impurities are the primary analytical requirements for sterile and non-sterile compounded drug products. We provide fast-turnaround testing formatted for compounding pharmacy quality programs.
Compounding pharmacies face increasing FDA and state board scrutiny following high-profile contamination incidents. Proactive analytical testing — particularly for sterile preparations — is both a regulatory requirement and a patient safety imperative.
Sterile compounded preparations require endotoxin testing, sterility testing, and for parenteral products, elemental impurities documentation per USP <232>/<233>.
Compounded oral medications, topicals, and injectables manufactured using organic solvents require USP <467> or ICH Q3C residual solvent testing before dispensing.
Injectable compounded preparations must meet ICH Q3D limits for elemental impurities. ICP-MS testing is required for non-sterile and sterile injectable formulations.
We support compounding pharmacy environmental monitoring programs with surface and air sampling analysis. Results are formatted for compliance with USP <797> requirements.
Each COA is formatted for integration into the pharmacy's batch record and dispensing documentation system. We provide digital and signed PDF copies with a signed header.
Analytical stability data supports extended beyond-use dating (BUD) for compounded preparations. We help pharmacies document the analytical basis for extended BUD assignments.
Key analytical services for compounding pharmacies:
Submitting takes less than 5 minutes. Most projects turn around in 5–10 business days from sample receipt.
Send a brief project description — sample type, quantity, and timeline. We confirm turnaround and quote within one business day.
We'll send a submission form and our San Diego shipping address. Most samples ship ambient or cold depending on stability requirements.
Results are delivered as a signed PDF COA within the agreed turnaround. Rush service (2–3 business days) is available for urgent timelines.
Send us your samples and receive a Certificate of Analysis. Results in 5–10 business days.