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Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis

30 Aug 2015

Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety, not just to satisfy competent authorities. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists. This application note proposed enhancements that can be applied to the sample preparation schemes outlined the USP <467> Residual Solvents general chapter. However, they can also be applied to all pharmacopeias complying with the ICH guidelines for residual solvents.

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Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Shipping / PackagingPackaging is the technology of enclosing or protecting products for distribution, storage, sale, and use and the process and production of packages. Packaging is closely linked to Shipping and the preparing of goods for transport, warehousing, logistics, sale, and end use. Within the pharmaceutical industry packaging and shipping are used for transport, storage and logistics between Contract Research Organizations (CROs), Manufacturing and Clinical Trial companies. Packaging is also critical in the final production of a pharmaceutical product before market. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Volatile Organic Compounds (VOCs)Volatile organic compounds (VOCs) are chemicals that have a low boiling point. Some VOCs are harmful to human health, whereas others can be used to determine the shelf-life of foods samples. Solvent MonitoringActive PharmaceuticalsThe Active Pharmaceutical Ingredient (API) of a drug is the component that causes the direct effect of the product. The remaining inactive components are known as excipients.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. USP Method

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Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis