Determination of elemental concentrations in pharmaceutical products can now be routinely performed at ChemCon via ICP–MS in conformation with USP <232> and <233>.
On February 1st, 2013 the USP (The United States Pharmacopeial Convention) published new requirements concerning the concentration of elemental impurities in pharmaceutical products. Two new chapters ( <232> ‘Elemental Impurities—Limits’, and <233> ‘Elemental Impurities—Procedures’) were introduced, describing the new limits of elemental impurities and how to measure inorganic contaminants. As of May 2014 these chapters will replace the previous tests, which measured the sum of all elemental impurities via a single determination. These new regulations will cause a step change in the way elemental impurities are measured in the pharmaceutical industry.
The total number of elements which have to be quantified for a specific substance can be reduced following a strict risk assessment of the process at hand. However, the so-called ‘Bad Four’ (arsenic, lead, cadmium and mercury) must always be included in this risk assessment. The USP prescribes the use of inductively coupled plasma mass spectrometry (ICP-MS) in Chapter <233> for these elemental concentration determinations. Accordingly, ChemCon GmbH has invested in a new ICP–MS system (complemented by a microwave sample digester) in preparation for these changes. The new Thermo Scientific ICAP Q was recently brought into full operation by the QC department, allowing complete compliance with the new analytical challenges facing the pharmaceutical industry. The ICAP Q is characterized by its ease of use, robustness and excellent operational characteristics, ensuring consistent and accurate results. These advantages are transmitted to our customers through the quality of the data which the system generates.
About ChemCon: ChemCon GmbH is a leading global supplier of high-quality active pharmaceutical ingredients (API) and fine chemicals, located in Freiburg, Germany. The company is specialized on small molecule chemistry – organic and inorganic. Based around chemical development on various stages of drug development ChemCon offers an all-in-one-hand service including full analytical support, complete documentation and outstanding quality management. Learn more about the company at www.chemcon.com.
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