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This document provides details on the characterization of follitropin concentrated solution, including: 1) It defines follitropin concentrated solution as a solution of a heterodimeric glycoprotein consisting of an α-chain and β-chain that is produced recombinantly in mammalian cells. 2) It lists requirements for host-cell derived proteins, host-cell and vector-derived DNA, and specifies a potency range of 9000-17000 IU per milligram. 3) It provides detailed procedures for identifying the solution throu

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Found Sun

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EN