Customized Reference Standard

Customized Reference Standard. Means any non-compendial or not commercially available substance that has been shown by an extensive set of analytical tests to be authentic material of high purity, obtained from existing production material of high purity, or prepared by further purification of existing production material. A list of Customized Reference Standards applicable to Acceptance Tests to be performed to determine that the Product supplied to Takeda conforms to the Drug Product Specifications is set forth in the... Restated Quality Agreement View More