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 accreditation-pending 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 an ISO 17025 accreditation pending Certificate of Analysis. Results in 5–10 business days.