[Problem] Provided is a freeze-dried preparation containing high-purity PTH peptide and a method for the production thereof. Also provided is a test method for PTH analogs to confirm the purity of a freeze-dried preparation containing PTH peptide, and the like.
[Solution] In the present invention, the presence of PTH analogs produced during the manufacturing process of a freeze-dried preparation containing PTH peptide was confirmed. The production of these PTH analogs was also discovered to be markedly prevented or reduced by controlling exposure of the solution containing PTH peptide and the like to air environments within a pharmaceutical production facility.
[问题]提供了一种含有高纯度
PTH 肽的冻干制剂及其生产方法。还提供了一种
PTH 类似物的检测方法,用于确认含有
PTH 肽的冻干制剂的纯度等。
[解决方案]在本发明中,确认了在含有
PTH 肽的冻干制剂的生产过程中产生的
PTH 类似物的存在。还发现通过控制含有
PTH 肽的溶液等暴露于制药生产设施内的空气环境中,可以明显防止或减少这些
PTH 类似物的产生。