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

Vol. 26

No. 4December 2017

目次Contents

改正案

Revision Drafts

第十七改正日本薬局方第二追補に収載予定の改正案（意見募集）その１
１. 通則 ························································ 499
２. 一般試験法(1) 新収載
2.26 ラマンスペクトル測定法 ····················· 499(2) 既収載
2.01 液体クロマトグラフィー ······················ 501
9.21 容量分析用標準液 ······························· 501
9.41 試薬・試液 ········································ 501
３. 参考情報(1) 新収載
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 ······································ 502(2) 既収載
医薬品原薬及び製剤の品質確保の基本的考え方······························································ 503
第十七改正日本薬局方第二追補に収載予定の改正案（意見募集）その２
１. 医薬品各条(1) 新収載
エチルセルロース ······································ 506
ガチフロキサシン水和物 ····························· 507
ガチフロキサシン点眼液 ····························· 509
シタグリプチンリン酸塩水和物····················· 510
シタグリプチンリン酸塩錠 ·························· 512
ヒドロキシエチルセルロース························ 514
ベラパミル塩酸塩注射液 ····························· 515
ラノコナゾール ········································· 516
ラノコナゾール外用液 ································ 517
ラノコナゾール軟膏 ··································· 518
ラノコナゾールクリーム ····························· 519(2) 既収載
軽質無水ケイ酸 ········································· 519
結晶セルロース ········································· 519

ヒドロコルチゾン・ジフェンヒドラミン軟膏 ··· 521
ヒプロメロース ·········································· 521
メチルセルロース ······································· 523
無水リン酸水素カルシウム ··························· 524(3) 既収載品目（医薬品各条）の有害試薬の排除に伴う改正について
エストリオール ·········································· 525
コレステロール ·········································· 525
テストステロンエナント酸エステル ··············· 525
デヒドロコール酸 ······································· 525
精製デヒドロコール酸 ································· 526
トリアムシノロンアセトニド ························ 526
ヒドロコルチゾン ······································· 526
ヒドロコルチゾン酢酸エステル ····················· 526
ベクロメタゾンプロピオン酸エステル ············ 526
ベタメタゾンジプロピオン酸エステル ············ 526
メストラノール ·········································· 526
メチルプレドニゾロン ································· 526
２. 医薬品各条（生薬等）(1) 既収載
オンジ ······················································ 527
オンジ末 ··················································· 527
カンゾウエキス ·········································· 527
カンゾウ粗エキス ······································· 527
ケツメイシ ················································ 527
センソ ······················································ 528
ベラドンナコン ·········································· 528
ホミカ ······················································ 528
ロートコン ················································ 528
３. 参照紫外可視吸収スペクトル
ガチフロキサシン水和物 ······························ 529
シタグリプチンリン酸塩水和物 ····················· 529
ラノコナゾール ·········································· 529
４. 参照赤外吸収スペクトル
エチルセルロース ······································· 530
ガチフロキサシン水和物 ······························ 530

ii
シタグリプチンリン酸塩水和物 ····················· 531
ラノコナゾール ·········································· 531

日本薬局方技術情報
Japanese PharmacopoeialTechnical Information

日本薬局方医薬品各条「サッカリンナトリウム」の確認試験を実施する上での留意点について） ········ 532「吸入剤の空気力学的粒度測定法」について（第十七改正日本薬局方第一追補 新規収載 一般試験法6.15） ························································ 536「ガラスインピンジャーによる吸入剤の空気力学的粒度測定法」について（第十七改正日本薬局方第一追補 新規収載 参考情報） ····························· 542

薬局方関連通知など

Authority Announcements

日本薬局方収載原案意見募集（平成 29 年 12 月分）に係るカラム情報の公開について ······················· 543
通則 5、46 の改正案の趣旨等について ················· 545
通則 13 及び参考情報「医薬品原薬及び製剤の品質確保の基本的考え方」の改正案の趣旨について ········ 546
参考情報「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」の収載案の趣旨について································································· 547
第十七改正日本薬局方正誤表の送付について（その２） ··························································· 548
第十七改正日本薬局方（英文版）正誤表の送付について ······························································ 552

国際調和Pharmacopoeial Harmonization

１. 日米欧三薬局方調和合意文書表紙（Sign-off CoverSheet of Harmonized Document）(1) 試験法1)新規①Conductivity ········································· 559(2) 各条
1)改正・訂正・表紙改正①Anhydrous Dibasic Calcium Phosphate (Rev. 2)··························································· 561②Cellulose, Microcrystalline (Rev. 2) ·········· 562③Hydroxypropylcellulose (Revision of Sign-off
Cover Sheet) ········································· 564④Hypromelose (Rev.2) ······························ 565⑤Methylcellulose (Rev. 3)·························· 566
２. 前号掲載「国際調和 PharmacopoeialHarmonization」の Revision 数の脱落について································································· 567

海外薬局方情報

Foreign Pharmacopoeial Information

医薬品の品質評価技術の評価···························· 568

標準品のご案内

Useful Information

日本薬局方等標準品の頒布のご案内 ················· 575
アメリカ薬局方標準品の取次販売のご案内 ········ 589
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 ··································· 591

総目次

Cumulative Contents

Vol.26 総目次 ·············································· 652～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Revision Drafts for Second Supplement to JP 17
１. General Notices ············································ 599
２. General Tests, Processes and Apparatus(1) Addition
2.26 Raman Spectrophotometry ······················ 599(2) Revision
2.01 Liquid Chromatography ························· 602
9.21 Standard Solutions for Voluemetric Analysis···························································· 602
9.41 Reagents, Test Solutions ························ 602
３. Official Monographs(1) Addition
Ethylcellulose ··········································· 603
Gatifloxacin Hydrate ··································· 605

Gatifloxacin Ophthalmic Solution ··················· 606
Hydroxyethylcellulose ································ 608
Lanoconazole ··········································· 611
Lanoconazole Cream ·································· 612
Lanoconazole Cutaneous Solution ··················· 613
Lanoconazole Ointment ······························· 614
Sitagliptin Phosphate Hydrate ························ 615
Sitagliptin Phosphate Tablets························· 617
Verapamil Hydrochloride Injection ················· 619(2) RevisionAnhydrous Dibasic Calcium Phosphate············· 620
Microcrystalline Cellulose ···························· 621
Hydrocortisone and Diphenhydramine Ointment·· 623
Hypromellose ··········································· 623
Methylcellulose ········································ 626
Light Anhydrous Silicic Acid ························ 628

ii(3) Revision－Elimination of harmful reagents inmonographs
Beclometasone Dipropionate ························· 628
Betamethasone Dipropionate ························· 628
Cholesterol ·············································· 628
Dehydrocholic Acid ···································· 628
Purified Dehydrocholic Acid ························· 628
Estriol ···················································· 629
Hydrocortisone ········································· 629
Hydrocortisone Acetate································ 629
Mestranol ················································ 629
Methylprednisolone ···································· 629
Testosterone Enanthate ································ 630
Triamcinolone Acetonide ····························· 630
４. Official Monographs－Crude Drugs(1) RevisionBelladonna Root ········································ 630
Cassia Seed ·············································· 630
Glycyrrhiza Extract ···································· 630
Crude Glycyrrhiza Extract ···························· 631
Nux Vomica ············································· 631
Polygala Root ··········································· 631Powdered Polygala Root ······························ 631
Scopolia Rhizome ······································ 632
Toad Cake ··············································· 632
５. Infrared Reference Spectra
Ethylcellulose ········································ 632
Gatifloxacin Hydrate ······························· 633
Lanoconazole ········································· 633

Sitagliptin Phosphate Hydrate ················· 633
６. Ultraviolet-visible Reference Spectra
Gatifloxacin Hydrate ······························ 634
Lanoconazole ········································· 634
Sitagliptin Phosphate Hydrate ················· 634

Pharmacopoeial Harmonization
１.Sign-off Cover Sheet of Harmonized Document(1) General Tests
1)Addition①Conductivity ········································· 559(2) Monographs
1)Revision・Correction・Revision of Cover Sheet①Anhydrous Dibasic Calcium Phosphate (Rev. 2)··························································· 561②Cellulose, Microcrystalline (Rev. 2) ·········· 562③Hydroxypropylcellulose (Revision of Sign-offCover Sheet) ········································· 564④Hypromelose (Rev.2) ······························ 565⑤Methylcellulose (Rev. 3)·························· 566

Useful InformationPMRJ Reference Standards Ordering Information
for Foreign Users ······································ 635

Cumulative Contents
Vol.26 Cumulative Contents ································· 655

次号（27 巻 1 号）出版月：2018 年 3 月
Publishing Schedule (Vol.27, No.1): March 2018