CS Analytical Expands Service Offering to Include USP 232 and 233 Elemental Impurity Testing


Applying our knowledge and skills to a new line of services dedicated to drug products, substances, excipients, and actual medical devices expands our ability to collaborate with new and existing customers on effective and comprehensive testing programs .

CS Analytical Laboratory, the world’s only FDA-regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for pharmaceutical and medical device container systems, is pleased to announce a new range of cGMP services specifically dedicated to USP 232 elemental impurities and USP 233 testing. While CS Analytical performs a large number of extractable metals tests on container systems and components, this new line of services will focus on actual pharmaceuticals, substances, excipients, and medical devices needed to meet USP guidelines or ICH for a wide variety of elemental substances. impurities. Common elemental impurities include the well-known arsenic and lead, but can also include a host of other metals that can have an adverse toxicological effect on the end user of a drug or medical device.

“The USP 232 and USP 233 testing capabilities are a natural extension of the work on extractable metals from container and packaging systems that we already do for a large number of customers. Applying our knowledge and skills to a new line of services dedicated to real drugs, substances, excipients and medical devices expands our ability to collaborate with new and existing customers on effective and comprehensive testing programs,” said Brandon Zurawlow, scientific director of CS Analytical. .

The ICH has very specific and well-defined guidelines for permissible daily exposure limits to elemental impurities for pharmaceuticals that apply to oral, inhalation and parenteral substances. Based on the guidelines, the USP defines acceptable exposure limits for elemental impurities in General Chapter 232 and specific test procedures for determining impurity levels in General Chapter 233. The Food and Drug Administration ( FDA) has further classified elemental impurities into three distinct categories. classes based on level of toxicity. Testing for elemental impurities of a drug product very closely resembles the test for extractable metals required for container and packaging systems, as outlined in USPs 661.1 and 661.2.

About CS Analysis Lab

The only FDA-regulated cGMP laboratory dedicated exclusively to the complex world of container and packaging qualification testing for drugs and medical devices, CS’s analytical team includes the world’s leading experts on all relevant USP and EP requirements, as well as thought leaders and pioneers of CCI (Container Closure Integrity Testing – CCI). Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as comprehensive USP 1207 services that cover basic feasibility studies, component qualification programs and development and validation of advanced methods for helium leak testing, vacuum decay, high voltage and headspace analysis. CS Analytical is the only source that can guarantee that your medical product container and packaging system meets stringent and complex regulatory requirements.

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