よむ、つかう、まなぶ。
・資料No.2～2-1_日本薬局方の参考情報の改正（案）について (15 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000174942_00007.html |
| 出典情報 | 薬事・食品衛生審議会 日本薬局方部会（令和4年度第1回 7／26）《厚生労働省》 |
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【原案６】.
目
次
参考情報 (案)
G0.
医薬品品質に関する基本的事項
化学合成される医薬品原薬及びその製剤の不純物に関する考え方〈G0-3-181〉 ········································· 1
G1.
理化学試験関連
システム適合性〈G1-2-181〉 ··········································································································· 2
近赤外吸収スペクトル測定法〈G1-3-161〉 ························································································· 3
液の色に関する機器測定法〈G1-4-181〉 ···························································································· 3
クロマトグラフィーのライフサイクル各ステージにおける管理戦略と変更管理の考え方（クロマトグラフィ
ーのライフサイクルにおける変更管理）〈G1-5-181〉 ······································································· 5
G2.
物性関連
せん断セル法による粉体の流動性測定法〈G2-5-181〉 ·········································································· 7
G4.
微生物関連
微生物試験における微生物の取扱いのバイオリスク管理〈G4-11-181〉 ··················································· 9
G5.
生薬関連
日本薬局方収載生薬の学名表記について〈G5-1-181〉 ········································································ 14
G6.
製剤関連
錠剤の摩損度試験法〈G6-5-181〉 ··································································································· 14
G9.
医薬品添加剤関連
製剤に関連する添加剤の機能性関連特性について〈G9-1-181〉 ···························································· 15
GZ.
その他
製薬用水の品質管理〈GZ-2-181〉··································································································· 16
14
目
次
参考情報 (案)
G0.
医薬品品質に関する基本的事項
化学合成される医薬品原薬及びその製剤の不純物に関する考え方〈G0-3-181〉 ········································· 1
G1.
理化学試験関連
システム適合性〈G1-2-181〉 ··········································································································· 2
近赤外吸収スペクトル測定法〈G1-3-161〉 ························································································· 3
液の色に関する機器測定法〈G1-4-181〉 ···························································································· 3
クロマトグラフィーのライフサイクル各ステージにおける管理戦略と変更管理の考え方（クロマトグラフィ
ーのライフサイクルにおける変更管理）〈G1-5-181〉 ······································································· 5
G2.
物性関連
せん断セル法による粉体の流動性測定法〈G2-5-181〉 ·········································································· 7
G4.
微生物関連
微生物試験における微生物の取扱いのバイオリスク管理〈G4-11-181〉 ··················································· 9
G5.
生薬関連
日本薬局方収載生薬の学名表記について〈G5-1-181〉 ········································································ 14
G6.
製剤関連
錠剤の摩損度試験法〈G6-5-181〉 ··································································································· 14
G9.
医薬品添加剤関連
製剤に関連する添加剤の機能性関連特性について〈G9-1-181〉 ···························································· 15
GZ.
その他
製薬用水の品質管理〈GZ-2-181〉··································································································· 16
14