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Heavy Metals Testing USP

 

Heavy Metals Testing USP <231>, <232>, and <233>

ACTA Laboratories, Inc. is a cGMP FDA Registered Testing Laboratory that performs USP <231> (wet chemistry testing for heavy metals) and USP <232>/<233> (ICP-MS testing for Elemental Impurities) on Pharmaceutical APIs (Active Pharmaceutical Ingredients) and Drug Products.

 

USP <231> Heavy Metals Testing

The current 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 is in the process of being replaced by quantitative procedures (USP <232> and <233>).

 

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 USP <231> procedure will be obsolete December 1, 2015. At that time, USP <232> and <233> will be effective for all USP materials.

 

If you would like to discuss any elemental impurities ICP-MS analysis needs, please contact ACTA Laboratories, Inc. at 949-595-0641 or info@actalabs.com

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