USP 1663 & 1664
Trust Gateway Analytical to guide your biopharmaceutical products towards meeting and exceeding safety standards. USP 1663 and 1664 are both guidelines for extractables and leachables (E&L) testing for the biopharmaceutical industry. These guidelines provide recommendations and best practices for the biopharmaceutical industry to ensure the quality and safety of their products.
Our services encompass comprehensive analytical testing for drug packaging & delivery systems and products, aligning with the recommendations for testing types, compound limits, and analytical methods.
United States Pharmacopeia 1663 (USP 1663)
USP 1663 provides guidelines for testing for systems used to manufacture biopharmaceuticals. The guidelines provide recommendations for extractables and leachables testing, including the types of testing required and the limits for acceptable levels of compounds. Regulatory agencies do not mandate compliance with USP 1663, but it is often used as a reference by the biopharmaceutical industry to ensure that their products meet the required safety standards.
United States Pharmacopeia 1664 (USP 1664)
USP 1664 is a guidance document developed by the Parenteral Drug Association (PDA) for E&L testing for the biopharmaceutical industry. The guidance provides recommendations for E&L testing for drug products and packaging/delivery systems used in the biopharmaceutical industry. The document provides recommendations for the types of testing required, the limits for acceptable levels of compounds, and the analytical methods that should be used. Regulatory agencies do not mandate compliance with 1664, but it is often used as a reference by the biopharmaceutical industry to ensure that their products meet the required safety standards.
