Elemental Impurities Testing USP
Elemental Impurities Testing USP <232> and <233>
ACTA Laboratories, Inc. is a cGMP FDA Registered Testing Laboratory that performs USP <232>/<233> (ICP-MS testing for Elemental Impurities) on Pharmaceutical APIs (Active Pharmaceutical Ingredients) and Drug Products. ACTA also performs the USP <231> Heavy Metals test (wet chemistry testing for heavy metals) for those clients that need this work.
USP <232> Elemental Impurities – Limits
USP <233> Elemental Impurities – Procedures
The new ICP-MS procedures are quantitative and will provide an accurate assessment of elemental impurities. The USP <232> Elemental Impurities Limits lists the proposed limits for allowable levels of elemental impurities in drug products and drug substances. The USP <233> Elemental Impurities Procedures outline the procedures to validate the method and perform routine analyses. The old USP <231> procedure was obsolete January 1, 2018. At this time, USP <232> and <233> will be effective for all USP materials.
USP <231> Heavy Metals Testing
The obsolete procedure in the USP for Heavy Metals testing is a wet chemistry test that utilizes sulfide to precipitate certain heavy metals (Pb, Hg, Bi, As, Sb, Sn, Cd, Ag, Cu, and Mo). The test sample preparation is visually examined to see if it is darker than the standard. This procedure is not quantitative and was replaced by quantitative procedures (USP <232> and <233>).
If you would like to discuss any elemental impurities ICP-MS analysis needs, please contact ACTA Laboratories, Inc. at 949-595-0641 or firstname.lastname@example.org