USP 1663 Pharmaceutical Packaging Test

EUROLAB laboratory provides testing and compliance service within the scope of USP 1663 standard. This standard provides a framework for the design, rationale and conduct of an extractable substance assessment for pharmaceutical packaging and distribution systems.

This section identifies the critical dimensions of an extractable assessment and discusses the practical and technical aspects of each dimension. While intended to be helpful and generally applicable, this section is for informational purposes only and does not establish acceptance criteria for particular extraction conditions, analytical procedures, or mandatory extractable specifications, and certain packaging and delivery systems or dosage forms; nor does it describe every situation in which a deducible assessment is required.

It is not possible for a general discussion of extractables to anticipate and cover all situations in which an evaluation of extractables may be necessary. Designing an individual extractable assessment is a process that balances sound science, prudent resource allocation, and effective risk management.

Achieving this balance is the responsibility and obligation of the pharmaceutical product manufacturer and requires consideration of all applicable legal and regulatory requirements. The principles and best proven practices outlined in this general section represent a consensus interpretation of sound science and are therefore applicable to any situation where extractable substance assessment is required for pharmaceutical application.

EUROLAB assists manufacturers with USP 1663 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.