CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems, is pleased to announce a new cGMP service line specifically dedicated to USP 232 and USP 233 Elemental Impurities testing. While CS Analytical performs a large volume of extractable metals testing on container systems and components, this new service line will be focused on actual drug product, substance, excipients, and medical devices required to meet either USP or ICH guidelines for a wide variety of elemental impurities. Common elemental impurities include well-known arsenic and lead, but also can include a host of other metals that may have a negative toxicological effect on the end-user of a drug or medical device product.

“USP 232 and USP 233 testing capabilities are a natural extension of the container and package system extractable metals work we already perform for a large number of clients. Applying our knowledge and skills to a new service line dedicated to actual drug product, substances, excipients, and medical devices expands our ability to collaborate with new and existing clients on efficient, comprehensive test programs,” stated Brandon Zurawlow, CS Analytical Chief Scientific Officer.

ICH has very specific and defined guidelines for permissible daily exposure limits of elemental impurities for drug products that are applicable to oral, inhalation and parenteral substances. Based upon the guidelines, the USP defines acceptable exposure limits to elemental impurities in general chapter 232 and the specific test procedures to determine the impurity levels in general chapter 233. The Food and Drug Administration (FDA) has further classified elemental impurities according to three distinct classes based upon level of toxicity. The elemental impurities testing of a drug product mirrors very closely to the extractable metals testing required of container and package systems as outlined in USP 661.1 and 661.2.