Stay Audit-Ready with Waters and USP <621>

Waters helps laboratories stay confident, compliant, and audit-ready when implementing adjustments under USP General Chapter <621>. By combining trusted LC technology with the industry leading Empower Chromatography Data System, Waters brings scientific leadership and regulatory expertise together to support modern chromatography labs. From automated system suitability calculations to traceable workflows and data integrity controls, our solutions and scientific insight help ensure that every allowable adjustment is scientifically justified and inspection ready.

  • Audit-ready workflows: Built-in calculations and documentation aligned with <621>

  • Scientific leadership: Guidance from Waters experts to support compliant method adjustments

  • Trusted by regulators and labs worldwide

Improving USP Monograph Analysis Time Through Scaling by N on an HPLC System Using CORTECS™️ Premier Columns

Focusing on practical method optimization within United States Pharmacopeia (USP) guidelines, this application note explores scaling by plate count (N) as an alternative to traditional L/dp adjustments. By transitioning to more efficient solid-core particles on a shorter column, the approach demonstrates how laboratories can reduce run times and solvent consumption while maintaining compliance—without requiring a full shift to UPLC instrumentation.

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Achieving Method Modernization within Gradient Allowances

Leveraging flexibility in United States Pharmacopeia Chapter <621>, this study highlights how gradient adjustments can enable method modernization on existing HPLC systems. Using the Alliance™️ iS platform, it illustrates how both system and column parameters can be refined to improve performance for abacavir sulfate analysis while remaining within compendial limits, offering a practical path to modernization without major infrastructure changes.

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From UHPLC to HPLC: Key Considerations for Method Scaling

Method transfer between chromatographic platforms requires careful balance between regulatory compliance and performance consistency. This white paper outlines the critical factors involved in scaling methods from UHPLC to HPLC, including system differences, method robustness, and lifecycle management. It emphasizes maintaining validated performance while adapting to evolving laboratory needs such as global method transfer, instrumentation changes, or manufacturing strategy shifts.

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USP Chapter <621> Calculating Signal-to-Noise in Empower Software

Providing practical guidance on recent updates to United States Pharmacopeia Chapter <621>, this Q&A explains how revised signal-to-noise requirements are implemented within Empower Software. It details how noise is calculated from blank injections and how parameters such as peak width at half height are applied, demonstrating that Empower natively supports harmonized pharmacopeial calculations while giving users flexibility to configure methods and maintain compliance.

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The Importance of Keeping Laboratory Software Updated

Modern laboratories depend on software to ensure data integrity, compliance, and operational efficiency. This white paper examines the risks associated with outdated systems, including security vulnerabilities and reduced productivity. It also highlights the benefits of staying current, such as improved functionality and regulatory alignment, underscoring why proactive software maintenance is essential for sustaining reliable, future-ready laboratory operations.

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