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

Vol. 28

No. 4

December 2019目

次Contents
改正案

Revision Drafts

第十八改正日本薬局方第一追補に収載予定の改正案（意見募集）
１. 医薬品各条（生薬等）(1) 既収載
コウボク ·················································· 539
ゴシツ ····················································· 539
ハマボウフウ ············································ 539
ボウイ ····················································· 539
２. 参考情報(1) 既収載
日本薬局方収載生薬の学名表記について········· 540
第十八改正日本薬局方第一追補に収載予定の改正案（意見募集）
１. 参考情報(1) 新収載
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 ························································ 540
第十八改正日本薬局方に収載予定の改正案（報告）１. 医薬品各条（化学薬品等）(1) 既収載
無水乳糖 ·················································· 544
乳糖水和物 ··············································· 545
精製白糖 ·················································· 545
第十八改正日本薬局方における医薬品各条に掲げた日本名別名の削除について（報告） ····························· 546
第十八改正日本薬局方収載予定の参考情報への固有番号の付与について（報告） ··································· 561
参考情報「第〇改正日本薬局方における国際調和」について（報告）························································ 563
第十八改正日本薬局方に収載予定の改正案（意見募集終了）
１. 通則 ························································ 563

２. 一般試験法(1) 既収載
2.48 水分測定法(カールフィッシャー法) ········· 563
9.41 試薬・試液 ········································· 566
３. 参考情報(1) 新収載
エンドトキシン試験法と測定試薬に遺伝子組換えタ
ンパク質を用いる代替法 ······························ 566
第十八改正日本薬局方に収載予定の改正案（意見募集）
１. 医薬品各条（化学薬品等）(1) 新収載
エリブリンメシル酸塩 ································· 569
クロペラスチンフェンジゾ酸塩 ····················· 573
クロペラスチンフェンジゾ酸塩錠 ·················· 574
シロドシン口腔内崩壊錠 ······························ 575
ピタバスタチンカルシウム口腔内崩壊錠 ········· 577
フェノバルビタール錠 ································· 578(2) 既収載
精製ゼラチン ············································· 579
低置換度ヒドロキシプロピルセルロース ········· 579
ヒプロメロース ·········································· 580
ホリナートカルシウム水和物 ························ 581
メチルセルロース ······································· 581
ラウリル硫酸ナトリウム ······························ 581
黄色ワセリン ············································· 582
白色ワセリン ············································· 583
２. 医薬品各条（生薬等）(1) 既収載
カンゾウ ··················································· 584
サイコ ······················································ 584
３. 参照紫外可視吸収スペクトル
クロペラスチンフェンジゾ酸塩 ····················· 585
４. 参照赤外吸収スペクトル
クロペラスチンフェンジゾ酸塩 ····················· 585
ラウリル硫酸ナトリウム ······························ 586
黄色ワセリン ············································· 586
白色ワセリン ············································· 586

ii「2.66 元素不純物試験法」について ··················· 599

クロスカルメロースナトリウム ·················· 719
２.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)改正・訂正・表紙改正①Conductivity (Corr. 1) ····························· 720② Dissolution (Rev. 3,Correction of the Sign-off
Cover Sheet) ············································ 723(2) 各条1)改正・訂正・表紙改正①Gelatin (Rev. 3)······································ 725②Sodium Laurylsulfate (Rev. 1) ·················· 726③Lactose, Anhydrous (Rev. 4, Corr. 1) ········· 727④Lactose, Monohydrate (Rev. 2, Corr. 1) ······ 729⑤Copovidone (Corr. 1) ······························· 731

薬局方関連通知など

海外薬局方情報第十八改正日本薬局方に収載予定の改正案の追加改正（意見募集）
１. 医薬品各条（化学薬品等）(1) 既収載
サッカリン ················································ 587
サッカリンナトリウム水和物 ························ 587
既収載品目（医薬品各条）の構造式、化学名及び CAS 登
録番号の改正について（報告） ····························· 589
既収載品目（9.41 試薬・試液）の「内部基準物質」の 用語に係る改正について（報告） ································ 598

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

Authority Announcements

一般試験法〈2.48〉水分測定法の改正案について ····· 603
医薬品各条 エリブリンメシル酸塩（案）について································································· 604
日本薬局方収載原案意見募集（令和元年 9 月 30 日分）に係るカラム情報の公開について ···················· 605
日本薬局方医薬品各条（生薬等）原案に係るカラムの情報の公開について ········································· 606
第十八改正日本薬局方原案作成要領(一部改正) ······ 608
第十八改正日本薬局方における医薬品各条に掲げた日本名別名の削除について（報告） ···················· 717

元素不純物－限度〈232〉に適合する医薬品原料の調製及び分析に関する技術ガイダンス ························· 733
USP 包装の基準－戦略と概観··························· 743

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 ················· 750
アメリカ薬局方標準品の取次販売のご案内 ········ 759
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 ··································· 760

総目次
国際調和

Foreign Pharmacopoeial Information

Cumulative ContentsVol. 28 総目次················································ 843

Pharmacopoeial Harmonization

１. Stage 2 案 (Official Inquiry Stage Draft)(1) 各条1)改正①Croscarmellose Sodium ··························· 718～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Revision Drafts for First Supplement to JP 18
１. Official Monographs－Crude Drugs(1) Revision
Achyranthes Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 766
Glehnia Root and Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 766
Magnolia Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 766
Sinomenium Stem and Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 766

２. General Information(1) Revision
On the Scientific Names of Crude Drugs listed in the JPꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 767
Drafts for JP 18
１. General Notices ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 768

iii

２. General Tests, Processes and Apparatus(1) Revision
2.48 Water Determination (Karl Fischer Method)ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 768
5.01 Crude Drugs Test ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 772
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 774
３. Official Monographs(1) Addition
Cloperastine Fendizoate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 778
Cloperastine Fendizoate Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 779
Eribulin Mesilate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 781
Phenobarbital Tabletsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 785
Pitavastatin Calcium Orally Disintegrating Tabletsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 786
Silodosin Orally Disintegrating Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 788(2) Revision
Calcium Folinate Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 791
Croscarmellose Sodium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 791
Low Substituted Hydroxypropylcellulose ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 793
Purified Gelatin ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 794
Hypromellose ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 794
Anhydrous Lactose ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 795
Lactose Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 795
Methylcellulose ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 796
Oxygen ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 797
White Petrolatumꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 798
Yellow Petrolatum ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 799
Sucrose ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 800
Sodium Lauryl Sulfate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 800
４. Official Monographs－Crude Drugs(1) Revision
Bupleurum Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 801
Glycyrrhiza ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 802
Goshuyuto Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 802
５. General Information(1) Addition
Bacterial Endotoxins Test and alternative methods using
recombinant protein-reagents for endotoxin assayꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 803
BioriskManagementof
theHandlingofMicroorganisms in Microbial Testsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 805
Radioactivity Measurements Method for Crude Drugsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 810
６. Infrared Reference Spectra
Cloperastine Fendizoate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 818
Sodium Lauryl Sulfate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 818
White Petrolatumꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 819
Yellow Petrolatum ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 819
７. Ultraviolet-visible Reference Spectra
Cloperastine Fendizoate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 820

Additional Revision of Drafts for JP 18
１. Official Monographs(1) Revision
Saccharin ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 820
Saccharin Sodium Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 821
Drafts for JP 18
１. General Tests, Processes and Apparatus(1) Revision
2.52 Thermal Analysis ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 822
4.06 Sterility Testꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 823
Revision of the term “ internal reference compound” forlisted articles (9.41 Reagent, Test Solutions) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 824
Deletion of “assay 1” for listed articles (9.41 Reagent, TestSolutions) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 825
Revision of the description of optical isomer for listed
articles (official monographs)
Bepotastine Besilate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 827
Clopidogrel Sulfate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 827
Dorzolamide Hydrochloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 828
Levofloxacin Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 829
Levofloxacin Fine Granules ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 829
Levofloxacin Injection ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 830
Levofloxacin Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 830
Montelukast Sodium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 831
Paroxetine Hydrochloride Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 831
Valaciclovir Hydrochloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 832
Valsartan ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 832
Voriconazole ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 833
Voriconazole for Injectionꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 833

Authority Announcements
Briefing on Proposed Draft Official Monograph “EribulinMesilate” ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 834

Useful Information
PMRJ Reference Standards Ordering Information for
Foreign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 835

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1) Monographs
1) Revision①Croscarmellose Sodium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 718
２. Sign-off Cover Sheet of Harmonized Document(1) General Tests
1) Revision・Correction・Revision of Cover Sheet①Conductivity (Corr. 1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 720②Dissolution (Rev. 3,Correction of the Sign-off CoverSheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 723

iv(2) Monographs
1) Revision・Correction・Revision of Cover Sheet①Gelatin (Rev. 3) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 725②Sodium Laurylsulfate (Rev. 1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 726③Lactose, Anhydrous (Rev. 4, Corr. 1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 727④Lactose, Monohydrate (Rev. 2, Corr. 1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 729⑤Copovidone (Corr. 1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 731

Cumulative ContentsVol. 28 Cumulative Contentsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 846

次号（29 巻 1 号）出版月：2020 年 3 月
Publishing Schedule (Vol.29, No.1): March 2020

JP Forum Vol. 28 No. 4 (2019)