To provide a scalable production method of a uniform-quality lyophilized preparation containing 6-fluoro-3-hydroxy-2-pyrazine carboxamide or its salt. The method of producing a lyophilized preparation containing amorphous sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide in the present invention is useful in producing a uniform quality of lyophilized preparation.提供一種包含6-氟-3-羥基-2-吡甲醯胺(6-fluoro-3-hydroxy-2-pyrazine carboxamide)或其鹽之均一品質的冷凍乾燥製劑之可規模放大的製造方法。本發明之包含6-氟-3-羥基-2-吡甲醯胺的鈉鹽的非晶質之冷凍乾燥製劑之製造方法可用作製造均一品質的冷凍乾燥製劑之方法。
