Albumin is available for use as an HSA excipient in North America, South America, some European countries, and Japan. There is no need to change HSA for countries worldwide in which Albumin is licensed as a therapeutic product.
Albumin meets United States Pharmacopeia (USP) specifications, and can be tested to European Pharmacopeia requirements. Additional key testing for Albumin includes:
The following resources provide regulatory standards, guidelines, and/or approval, in varying capacities, for the geographies they serve. More information on approvals and regulatory processes can be obtained by contacting them.
Additional information on the current state of excipient-related products is provided by:
