CS Analytical Expands USP 661.1 Service Offering with HPLC & GC Instrument Capabilities

With the USP formally implementing a series of test method updates to USP 661.1 and USP 661.2 effective December 1^st 2025 it is imperative that the CS Analytical Team be prepared to help our client base navigate these new and more complex test methods. The addition of HPLC and GC capabilities enables us to meet this objective especially as it relates to plastic additive testing

CLIFTON, N.J., Oct. 22, 2025 /PRNewswire/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and testing services specifically for drug product and medical device package systems, is excited to announce that it has made a capital investment in HPLC (High Performance Liquid Chromatography) and GC (Gas Chromatography) instruments to further expand its service offering specific to USP 661.1 testing requirements. These specific instruments play a crucial role in the plastic additives testing as outlined by the USP for all plastic materials of construction used in the formation of container and package systems.

As stated by Ronak Patel, CS Analytical Chemistry Service Laboratory Manager, "With the USP formally implementing a series of test method updates to USP 661.1 and USP 661.2 effective December 1^st 2025 it is imperative that the CS Analytical Team be prepared to help our client base navigate these new and more complex test methods especially as it relates to plastic additives. The addition of HPLC and GC capabilities enables us to meet this objective."

USP 661.1 is a standard for testing individual plastic materials used in pharmaceutical packaging to confirm their identity, biological reactivity, general physicochemical properties, and composition. This testing ensures that the raw plastic material is well-characterized and suitable for its intended use before it is used to create a component. Key aspects of the testing include assessing biological reactivity, establishing physicochemical properties and confirming the identity and additives of the plastic resin.

The CS Analytical Team currently offers complete USP 661.1 and USP 661.2 testing services for all plastic material types that may be used in the production of plastic based container and package systems. Whether a traditional solid oral dose in an HDPE bottle, a unique drug delivery system, a challenging and oversized IV bag system, the CS Analytical Team has the knowledge and hands-on experience to develop a qualification test program for all types of plastic container and package systems that ensures all development goals and regulatory compliance factors are met.

About CS Analytical Laboratory
The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world's leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP 1207 services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.

SOURCE CS Analytical