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CS Analytical Laboratory Enhances Testing Services with HPLC and GC Instrumentation

CS Analytical Laboratory, the only FDA regulated contract laboratory focused exclusively on regulatory solutions and testing services for drug products and medical device packaging, has recently expanded its capabilities significantly. With a new investment in High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) technology, CS Analytical is poised to better serve its clients in light of updated testing requirements under USP 661.1 and USP 661.2, effective December 1st, 2025.

The latest updates introduced by the United States Pharmacopeia (USP) necessitate a robust testing framework that CS Analytical is ready to fulfill. According to Ronak Patel, the lab’s Chemistry Service Laboratory Manager, the enhancements are critical for helping clients navigate the increasingly complex landscape of testing methods—particularly as they pertain to the testing of plastic additives.

Understanding USP 661.1 and Its Importance

USP 661.1 establishes standards for testing individual plastic materials intended for pharmaceutical packaging. These rigorous tests assess the identity, biological reactivity, physiochemical properties, and composition of plastic materials used in the creation of containers and packaging systems. Such thorough testing ensures that the plastics are well-characterized for their intended applications, which is vital in preserving the integrity of drug products.

Tests under USP 661.1 specifically focus on several key aspects:

• - Biological Reactivity: Ensures that the materials do not adversely affect the pharmaceutical content.
• - Physicochemical Properties: Evaluates the physical and chemical characteristics relevant to functionality and safety.
• - Additives and Composition: Confirms that the plastic materials do not contain prohibited substances that might compromise the product.

CS Analytical has long been recognized for its comprehensive service offering in relation to USP 661.1 and 661.2, providing testing for various plastic materials used in packaging systems. From traditional HDPE bottles to sophisticated IV bag systems, the laboratory boasts a wealth of knowledge and experience, ensuring compliance with regulatory requirements and assisting in the development of qualification test programs.

Commitment to Regulatory Compliance and Client Needs

CS Analytical’s investment in HPLC and GC instruments substantiates its commitment to meeting both current and future regulatory demands. This upgrade in technology will particularly enhance their capabilities in plastic additives testing, an area of increasing concern in the pharmaceutical industry.

Patel emphasizes that the incorporation of these advanced instruments is not just about expanding their toolbox; it's about ensuring that every plastic component used in medical packaging meets stringent safety and efficacy standards set forth by regulatory bodies. By doing so, CS Analytical not only aids individual clients in navigating these challenges but also supports the broader pharmaceutical community in maintaining the safety and efficacy of drug products.

A Leader in Laboratory Services

As a leader in the FDA regulated and cGMP-compliant laboratory space, CS Analytical is uniquely positioned to provide expertise in container qualification testing. The laboratory has become synonymous with excellence in executing USP, EP, and JP procedures across various materials, advancing the frontiers of container closure integrity (CCI) testing. Their full suite of laboratory services includes everything from basic feasibility studies to advanced method development and validation tailored for an array of critical testing methodologies.

With their continuous investment in state-of-the-art technology and unwavering focus on regulatory compliance, CS Analytical stands out as the essential partner for any organization seeking to ensure that their medical packaging systems are primed for success in the rigorous pharmaceutical landscape of today and tomorrow.

Conclusion

In summary, CS Analytical Laboratory’s expansion of their testing capabilities with HPLC and GC technology represents a significant step forward in addressing the evolving needs of the pharmaceutical industry. As regulatory requirements become more intricate and demanding, having a reliable laboratory partner with the necessary resources and expertise becomes indispensable. CS Analytical is committed to helping its clients navigate these waters effectively, ensuring compliance and the success of pharmaceutical packaging systems.