USP <233> Elemental Impurities — Procedures
Issued by United States Pharmacopeia (USP)
StandardAudit Scope
Specifies analytical procedures (ICP-MS and ICP-OES) for quantifying elemental impurities defined in USP <232>. Includes sample preparation, instrument validation, system suitability, and acceptance criteria.
What It Proves
A laboratory used USP-specified ICP-MS or ICP-OES procedures (with validated methodology) to quantify elemental impurities in a sample.
What It Does Not Prove
USP <233> describes METHODS, not pass/fail thresholds (those are in <232>). A '<233> tested' claim without paired <232> result interpretation is incomplete. A lab performing <233> procedures must be ISO/IEC 17025 accredited for the specific test scope for results to be third-party defensible; in-house <233> is self-declaration.
How Vendors Report It
You may see this listed as:
Related Glossary Concepts
Evaluating Manufacturer Credentials?
Our directory shows certification status, verification details, and assessment rationale for every listed vendor.