USP <232> and <233> establish permitted daily exposure (PDE) limits and ICP-MS test procedures for elemental impurities in pharmaceutical drug products. We deliver sub-ppb detection with full ICH Q3D compliance documentation for oral, inhalation, and parenteral product classes.
USP <232> applies to all new pharmaceutical drug products. ICH Q3D defines PDEs for 24 elemental impurities across oral, parenteral, and inhalation routes. Compliance is required for FDA and ICH market submissions.
Finished drug products must demonstrate that elemental impurities — from manufacturing equipment, excipients, and water — do not exceed ICH Q3D PDEs.
Botanical and mineral-derived ingredients often carry elevated background metals from soil and processing. ICP-MS verifies levels against route-specific limits.
Metal leaching from reactors, columns, and filtration equipment must be assessed as part of the elemental impurity risk assessment (EIRA).
Purified water, WFI, and excipients used in sterile manufacturing require elemental testing under the Option 1 or Option 2 compliance pathway.
New chemical entities must include an elemental impurities risk assessment in IND and NDA filings, with speciated ICP-MS data for Class 1 and 2A elements.
USP <2232> extends the elemental impurities concept to dietary supplements. Major retailers increasingly require ICP-MS COA for Pb, Cd, As, and Hg.
We routinely test the following elements per ICH Q3D classification:
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.