| 摘要 |
PROBLEM TO BE SOLVED: To provide high purity PTH peptide-containing lyophilized products, to provide a production method thereof, and to provide an inspection method of the PTH related substance for inspecting the purity of PTH peptide-containing lyophilized products.SOLUTION: In the invention, presence of the PTH related substance produced during manufacturing process of PTH peptide-containing lyophilized products is confirmed. Further, production of the PTH related substance concerned is found out to be prevented and reduced significantly by suppressing exposure to atmospheric environment in manufacturing facilities of pharmaceuticals, such as PTH peptide-containing solution.SELECTED DRAWING: Figure 2 |
