USP <467> is the compendial standard for residual solvents in pharmaceutical ingredients and drug products. We run Procedure A and B headspace GC/FID analysis with quantification against ICH Q3C Class 1, 2, and 3 limits — returning a signed COA in 5–10 business days.
Any product registered in the United States Pharmacopeia or intended for pharmaceutical use must demonstrate residual solvent compliance under USP <467>. Testing requirements apply at the ingredient and finished-product level.
Active pharmaceutical ingredients produced via organic synthesis require solvent compliance before IND/NDA submission or CMO batch release.
Hexane, ethanol, and ethyl acetate extraction processes must be documented. USP <467> applies to dietary supplement ingredients used in OTC drug products.
Tablets, capsules, topicals, and injectables must pass USP <467> as part of batch release, even when the excipients — not the API — introduce solvents.
Pharmaceutical excipients sold to drug manufacturers must comply with USP <467> under the "Option 1" total daily exposure approach.
CMOs must verify that products manufactured for brand clients meet USP <467> limits. Our COA is formatted for direct inclusion in CMO quality systems.
Reference standard materials used in pharmaceutical QC labs require residual solvent documentation. We test neat solids and solutions.
We test for the full USP <467> solvent list. Common client requests include:
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.