The present invention provides the dry preparation of high-purity peptide containing the PTH freezing universe and its manufacturing methods. Additionally provide the inspection method of the PTH analogs with the purity of the what confirmation freezing dry preparation of the universe of peptide containing PTH etc.. It confirmed the presence of the PTH analogs generated in the manufacturing process that peptide containing PTH freezes the dry preparation of the universe in the present invention. It has furthermore been found that the generation of the PTH analogs significant in air environment can obtain preventing from reducing by inhibiting peptide solution containing PTH etc. be exposed in pharmaceuticals manufacturing facility.本發明提供了高純度含PTH肽冷凍乾燥製劑及其製造方法。還提供了用於確認含PTH肽冷凍乾燥製劑的純度等的PTH類似物的檢查方法。本發明中確認了在含PTH肽冷凍乾燥製劑的製造工序中生成的PTH類似物的存在。進一步發現，該PTH類似物的生成可通過抑制含PTH肽溶液等暴露在醫藥品製造設施內空氣環境中而顯著得到防止．降低。
