The Science

The control and characterization of a drug substance and its impurities is an essential and highly regulated aspect of the drug development process. Improving the understanding of known and unknown components within your sample will ultimately help mitigate impact on patient safety, and minimize the likelihood of potential delays in commercialization, drug shortages, or even product recalls.

Explore the scientific resources found on this page to help align your workflow with ICH guidelines, ensuring the quality, safety, and efficacy of your drug substance.

Mutagenic and Genotoxic Impurities

Genotoxic impurities pose a significant challenge for the pharmaceutical industry. The identification and control of these impurities is challenging due to their high reactivity, diverse properties, and the need to control them at levels much lower than what is typically found in traditional impurities. Recent introduction of regulatory guidance provides a roadmap for their assessment, characterization of risk, and control. Waters offers applications and resources to address these challenges.

Extractables and Leachables

Extractables and leachables characterization is one of the requirements for new drug applications. Waters resources include hardware solutions to address the recommended testing strategies in PQRI guidelines as well as USP chapters 1663 and 1664. In addition, scientific data management systems provide streamlined workflows for targeted and non-targeted screening data interpretation.

Method modernization

While pharmaceutical companies expect to utilize analytical instrumentation for many years, today’s robust technology often surpasses their projections of asset utilization. Robust technologies that last often delay or inhibit the development of new methods. Method modernization and lifecycle management initiatives are aimed at facilitating industry adoption of new technologies to further improve the quality and safety of their therapeutics. Waters aims to provide clarity about how new technologies can positively impact your business without disrupting current scientific workflows. Waters offers modernization pathways with instrumentation such as ACQUITY Arc, improved data integrity with Empower 3 Chromatography Data System, and progressive column technologies that facilitate adoption of USP Chapter <621> allowances.

Pharmaceutical Stability

Stability testing of pharmaceutical products is required to ensure potency, safety, and efficacy of products during the shelf life expectancy. Recent changes issued by the FDA regulatory agency requires increased stability testing, placing additional burden on generic drug manufacturers submitting ANDAs. Often, the interpretation of stability studies are designed and executed using traditional LIMS systems or spreadsheets, however these can be difficult to implement or prone to human error thus leading to compromising gaps in data integrity. Recently, Waters introduced the NuGenesis Stability Module which makes setting up and executing robust stability studies easy while being easy with efficient implementation at any organization.

Development and Validation of Analytical Procedures

Validation of analytical procedures involves the execution of a number of experiments, often across numerous labs. In addition, compilation of the data is frequently done manually which can lead to transcription errors and inconsistent reporting. Complicating this are regulatory requirements which call for appropriate data integrity and traceability to sufficiently prove validation. Waters’ Empower Chromatography Software with Method Validation Manager allows users to define, execute, and report validation studies in a compliant manner.

Impurities in Drug Product and Drug Substance

The assessment and control of impurities is as important in the drug substance material as it is in the final drug product, but both have their unique challenges and reporting thresholds. Assessment is required for both drug substance and drug product and includes organic impurities, trace metals, and residual solvents. In each case, impurities need to be assessed for their overall abundance and if necessary identified according to well-defined thresholds. Waters provides a comprehensive combination of technologies that enable laboratories around the globe to accurately detect, identify, and monitor impurities across the product development pipeline.

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