Elemental Impurities: new USP chapters <232>, <233>, and <2232>
New USP Chapters
Drug products and dietary supplements for the US market have to comply with the new elemental impurities requirements and testing set forth by the USP General Chapters <232> Elemental Impurities—Limits, <233> Elemental Impurities—Procedures, and <2232> Elemental Contaminants in Dietary Supplements. The USP recognized that the current chapter <231> Heavy Metals is obsolete, and has been eliminated completely as of 1/1/2018, when the new chapters were officially implemented.
These new chapters include the use of modern procedures and analytical equipment, and establish the limits for acceptable levels of elemental impurities in drug products and dietary supplements. These changes will affect not just the drug manufacturers but also the raw materials supplier for active pharmaceutical ingredients (APIs) and/or excipients.
Impact Analytical has extensive experience developing new methods, validation processes, and testing for the pharmaceutical and raw materials industries. Contact us today to discuss your elemental analysis needs.
For years Impact Analytical has been providing elemental analysis for our clients. When you work with us, our experts will consult with you right from the start to help determine what elemental impurities service we can assist you with. Our laboratory, which operates under cGMP/GLP guidelines, is able to analyze drug products, API’s, and excipients. Utilizing modern techniques such as inductively coupled plasma – optical emission spectroscopy (ICP-OES) and inductively coupled plasma – mass spectrometry (ICP-MS), Impact Analytical can identify and quantify a wide range of trace elements including each of the metals listed in USP 232, 233, and 2232.
At Impact Analytical we have the sample preparation capabilities you need to prepare your product for analysis. Many drug products require closed vessel microwave digestion to break down and dissolve the elemental constituents of the product. We can provide microwave digestion along with other popular preparation techniques such as hot plate digestion, hydrofluoric acid (HF) digestion, extractions, evaporation, separation, and sample milling amongst others.
- ICP-MS: can detect over 60 elements simultaneously with extreme sensitivity and the best detection limits.
- ICP-OES: can detect over 60 elements simultaneously while being robust and capable of dealing with difficult matrixes.
Impact Analytical complies with the Good Laboratory Practice (GLP) regulations and current Good Manufacturing Practice (cGMP), and it is a registered facility with the FDA and is also licensed with the DEA. Don’t have a method? Let our experienced staff develop and validate a method that is uniquely designed for your materials.