日本薬局方フォーラム
Japanese Pharmacopoeial Forum

Vol. 33 No. 2

June 2024目

次Contents
改正案

Revision Drafts

第十九改正日本薬局方に収載予定の改正案(意見募集)
１. 通則 ························································· 161
２. 一般試験法(1) 既収載
7.01 注射剤用ガラス容器試験法 ·················· 161
9.41 試薬・試液 ······································· 163
9.62 計量器・用器 ······································ 165
３. 参考情報(1) 新収載
微生物学的試験法の適合性試験等における留意事項<G4-12-190> ·············································· 165
1H スピン情報に基づいた参照 NMR スペクトルと日本薬局方試薬への応用〈G5-9-190〉 ············ 166
既収載品目（医薬品各条(生薬等)）の定量法の改正について（意見募集）
釣藤散エキス ············································ 169
チンピ ····················································· 169
補中益気湯エキス ······································ 169
抑肝散加陳皮半夏エキス ····························· 169
六君子湯エキス ········································· 169
第十九改正日本薬局方に収載予定の改正案(意見募集)
１. 一般試験法(1) 既収載
6.05 注射剤の採取容量試験法 ····················· 170
9.41 試薬・試液 ······································· 170
２. 医薬品各条（化学薬品等）(1) 新収載
シロップ用 L－カルボシステイン ·················· 172
ミドドリン塩酸塩 ······································ 173
ミドドリン塩酸塩錠 ··································· 174
ミドドリン塩酸塩口腔内崩壊錠····················· 176
レベチラセタム ········································· 177
レベチラセタム錠 ······································ 179(2) 既収載
ダウノルビシン塩酸塩 ································ 181
３. 医薬品各条（生薬等）(1) 既収載

エンゴサク ················································ 181
エンゴサク末 ············································· 182
カノコソウ ················································ 182
カノコソウ末 ············································· 182
４. 参照紫外可視吸収スペクトル
ミドドリン塩酸塩 ······································· 183
５. 参照赤外吸収スペクトル
ミドドリン塩酸塩 ······································· 184
レベチラセタム ·········································· 184

薬局方関連通知など

Useful Information

日本薬局方収載原案意見募集（2024 年 6 月 3 日分）に係るカラム情報の公開について ······················· 185
通則 39 及び一般試験法「9.62 計量器・用器」の改正について ························································ 186
一般試験法「6.05 注射剤の採取容量試験法」の改正案について ····················································· 187
参考情報「1H スピン情報に基づいた参照 NMR スペク
トルと日本薬局方試薬への応用」 の新規作成について ······························································ 188

日本薬局方技術情報
Japanese Pharmacopoeial Technical Information

新規参考情報「1H スピン情報に基づいた参照 NMR
スペクトルと 日本薬局方試薬への応用〈G5-9-190〉」について ·························································· 189

国際調和Pharmacopoeial Harmonization

１. Stage 2 案(Official Inquiry Stage Draft)(1) 試験法1)改正① Test for Extractable Volume of ParenteralPreparations ············································· 193

標準品のご案内Reference Standards

日本薬局方等標準品の頒布のご案内 ·················· 195
USP 標準品の取次販売のご案内 ······················· 205

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LGC Standards 社不純物標準物質等および EP 標準品の取次販売のご案内 ··································· 206～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Drafts for JP 19
１. General Notices(1) Revision
General Notices ······································· 211
２. General Tests, Processes and Apparatus(1) Revision
6.05 Test for Extractable Volume of ParenteralPreparations ············································· 211
9.41 Reagents, Test Solutions ························ 212
9.62 Measuring Instruments, Appliances ··········· 213
３.Official Monographs(1) Addition
L-Carbocisteine for Syrup ····························· 214
Levetiracetam ··········································· 216
Levetiracetam Tablets ·································· 218
Midodrine Hydrochloride ····························· 220
Midodrine Hydrochloride Orally Disintegrating
Tablets ··················································· 222
Midodrine Hydrochloride Tablets ···················· 224(2) Revision
Daunorubicin Hydrochloride ·························· 226
４. Official Monographs－Crude Drugs(1) Revision
Corydalis Tuber ········································· 227
Powdered Corydalis Tuber ···························· 227Japanese Valerian······································· 228

Powdered Japanese Valerian ·························· 228
５. Infrared Reference Spectra
Levetiracetam ··········································· 229
Midodrine Hydrochloride ····························· 229
６. Ultraviolet-visible Reference Spectra
Midodrine Hydrochloride ····························· 230
７. General Information(1) Addition
Points to Consider in Suitability Testing, etc. ofMicrobial Tests〈G4-12-190〉 ······················ 230
Reference NMR Spectrum Based on 1H Spin
Parameters and Application to Reagents in theJapanese Pharmacopoeia 〈G5-9-190〉 ············ 232

Reference Standards
PMRJ
ReferenceStandards
Ordering
Information for Foreign Users ····················· 234

Pharmacopoeial Harmonization
１．Stage 2(Official Inquiry Stage Draft)(1) Tests
1)Revision① Test for Extractable Volume of ParenteralPreparations ············································· 193

次号（33 巻 3 号）出版月：2024 年 9 月
Publishing Schedule (Vol.33, No.3):September 2024