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レギュラトリーサイエンス・基準作成調査・日本薬局方

日局におけるPDG調和文書への対応状況（医薬品各条）

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調和合意された医薬品各条について、PDG （Pharmacopoeial Discussion Group：薬局方調和国際会議）の調和文書表紙（Sign-off Cover Sheet （注））を掲載しています。なお、2020年12月22日の調和合意分より、調和文書表紙だけではなく、調和文書全体を公開しております。（詳しくは、2020年11月PDGテレビ会議議事要旨[358KB]をご参照ください。）
（注）PDG調和文書の表紙：各薬局方による署名及び調和・非調和項目や独自記載事項等の情報を記載。
改正版と施行日の対応についてはこちら[41.7KB]をご確認ください。

As of July 3, 2024

各条（医薬品添加物）

  • E-01 / Alcohol　エタノール
Harmonization No. Sign-off 施行日
　初回調和 October 24, 2001[34.9KB] -
　Rev. 1 September 9, 2002[115KB] April 1, 2006
　Rev. 2 November 7, 2012[37.4KB] February 28, 2014
　Rev. 2, Corr. 1 June 27, 2013[32.7KB] April 1, 2016
　Rev. 2, Corr. 2 June 26, 2014[19.2KB] April 1, 2016
　Corr. of Sign-off cover sheet November 15, 2021[31.3KB] December 12, 2022

 

  • E-02 / Dehydrated Alcohol　無水エタノール
Harmonization No. Sign-off 施行日
　初回調和 October 24, 2001[30.5KB] -
　Rev. 1 September 9, 2002[109KB] April 1, 2006
　Rev. 2 November 7, 2012[37.5KB] February 28, 2014
　Rev. 2, Corr. 1 June 27, 2013[32.4KB] April 1, 2016
　Rev. 2, Corr. 2 June 26, 2014[19.1KB] April 1, 2016
　Corr. of Sign-off cover sheet November 15, 2021[31.4KB] December 12, 2022

 

  • E-03 / Benzyl Alcohol　ベンジルアルコール
Harmonization No. Sign-off 施行日
　初回調和 July 18, 2000[27.2KB] January 1, 2005
　Rev. 1 November 8, 2005[99.7KB] April 1, 2006
　Rev. 2 June 3, 2008[28.9KB] April 1, 2011
　Rev. 2, Corr. 1 June 15, 2011[32.1KB] October 1, 2012
　Rev. 2, Corr. 2 December 22, 2020[434KB] December 12, 2022

 

  • E-04 / Calcium Disodium Edetate　エデト酸カルシウムナトリウム水和物
Harmonization No. Sign-off 施行日
　初回調和 November 8, 2005[104KB] February 28, 2014
　Corr. of Sign-off cover sheet January 20, 2023[361KB] December 12, 2022
　Rev. 1 (Stage 2)  

 

  • E-05 / Calcium Phosphate Dibasic　リン酸水素カルシウム水和物
Harmonization No. Sign-off 施行日
　初回調和 November 8, 2005[111KB] October 1, 2007
　Rev. 1 June 15, 2011[44.2KB] October 1, 2012
　Corr. of Sign-off cover sheet January 20, 2023[371KB] December 12, 2022

 

  • E-06 / Calcium Phosphate Dibasic  Anhydrous　無水リン酸水素カルシウム
Harmonization No. Sign-off 施行日
　初回調和 November 8, 2005[112KB] October 1, 2007
　Rev. 1 June 15, 2011[43.0KB] October 1, 2012
　Rev. 2 September 13, 2017[36.7KB] June 28, 2019
　Corr. of Sign-off cover sheet November 15, 2021[26.3KB] -
　Corr. of Sign-off cover sheet January 20, 2023[376KB] December 12, 2022

 

  • E-07 / Carmellose Calcium　カルメロースカルシウム
Harmonization No. Sign-off 施行日
　初回調和 October 24, 2001[34.6KB] -
　Rev. 1 July 17, 2003[108KB] January 1, 2005
　Rev. 1, Corr. 1 January 20, 2023[995KB] June 28, 2024

 

  • E-08 / Carmellose Sodium　（調和作業中）

 

  • E-09 / Croscarmellose Sodium　クロスカルメロースナトリウム
Harmonization No. Sign-off 施行日
　初回調和 October 24, 2001[116KB] April 1, 2006
　Rev. of Sign-off cover sheet May 26, 2016[681KB] December 12, 2022
　Rev. 1 December 22, 2020[129KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[364KB] December 12, 2022
　Rev. 2 (Stage 2)  

 

  • E-10 / Cellulose, Microcrystalline　結晶セルロース
Harmonization No. Sign-off 施行日
　初回調和 February 18, 2004[41.8KB] -
　Rev. 1 May 11, 2005[125KB] April 1, 2006
　Rev. 1, Rev. of Sign-off cover sheet May 26, 2016[708KB] June 28, 2019
　Rev. 2 September 13, 2017[465KB] June 28, 2019
　Rev. 3 October 3, 2018[656KB] June 28, 2019
　Corr. of Sign-off cover sheet November 15, 2021[35.1KB] -
　Corr. of Sign-off cover sheet January 20, 2023[408KB] December 12, 2022

 

  • E-11 / Cellulose, Powdered　粉末セルロース
Harmonization No. Sign-off 施行日
　初回調和 February 18, 2004[32.8KB] -
　Rev. 1 May 11, 2005[102KB] April 1, 2006
　Rev. 1, Rev. of Sign-off Cover Sheet May 26, 2016[627KB] December 12, 2022
　Rev. 1, Corr. 1 November 15, 2021[85.3KB] -
　Rev. 1, Corr. 1 January 20, 2023[362KB] December 12, 2022

 

  • E-13 / Cellulose Acetate Phthalate　セラセフェート
Harmonization No. Sign-off 施行日
　初回調和 October 24, 2001[32.6KB] January 1, 2005
　Rev. 1 November 9, 2010[45.4KB] October 1, 2012
　Rev. 1, Corr. 1 June 6, 2012[27.8KB] October 1, 2012
　Corr. of Sign-off cover sheet November 15, 2021[26.0KB] -
　Corr. of Sign-off cover sheet January 20, 2023[381KB] December 12, 2022

 

  • E-14 / Citric Acid, Anhydrous　無水クエン酸
Harmonization No. Sign-off 施行日
　初回調和 May 23, 2001[32.2KB] January 1, 2003
　Rev. 1 November 11, 2003[109KB] April 1, 2006
　Rev. 2 June 9, 2010[29.8KB] October 1, 2012
　Corr. of Sign-off cover sheet January 20, 2023[355KB] December 12, 2022

 

  • E-15 / Citric Acid, Monohydrate　クエン酸水和物
Harmonization No. Sign-off 施行日
　初回調和 May 23, 2001[31.8KB] January 1, 2003
　Rev. 1 November 11, 2003[108KB] April 1, 2006
　Rev. 2 June 9, 2010[29.8KB] October 1, 2012
　Corr. of Sign-off cover sheet January 20, 2023[338KB] December 12, 2022

 

  • E-16 / Crospovidone　クロスポビドン
Hamonization No. Sign-off 施行日
　初回調和 November 9, 2010[41.2KB] October 1, 2012
　Corr. of Sign-off cover sheet October 3, 2018[615KB] -
　Corr. of Sign-off cover sheet November 15, 2021[24.0KB] -
　Corr. of Sign-off cover sheet January 20, 2023[374KB] December 12, 2022

 

  • E-17 / Ethylcellulose　エチルセルロース
Harmonization No. Sign-off 施行日
　初回調和 February 6, 2002[115KB] -
　Rev. 1 October 27, 2009[31.8KB] -
　Rev. 2 May 26, 2016[468KB] June 28, 2019
　Corr. of Sign-off cover sheet January 20, 2023[403KB] December 12, 2022

 

  • E-18 / Hydroxyethylcellulose　ヒドロキシエチルセルロース
Harmonization No. Sign-off 施行日
　初回調和 July 25, 2016[260KB] June 28, 2019
　Corr. of Sign-off cover sheet November 15, 2021[28.1KB] -
　Corr. of Sign-off cover sheet January 20, 2023[389KB] December 12, 2022
　Rev. 1 (Stage 1)  

 

  • E-19 / Hydroxypropylcellulose　ヒドロキシプロピルセルロース
Harmonization No. Sign-off 施行日
　初回調和 June 27, 2013[24.2KB] April 1, 2016
　Rev. of Sign-off cover sheet September 13, 2017[498KB] June 28, 2019
　Corr. of Sign-off cover sheet November 15, 2021[27.3KB] -
　Corr. of Sign-off cover sheet January 20, 2023[368KB] December 12, 2022

 

  • E-20 / Hydroxypropylcellulose, Low Substituted　低置換度ヒドロキシプロピルセルロース
Harmonization No. Sign-off 施行日
　初回調和 November 13, 2014[451KB] December 1, 2017
　Corr. 1 July 1, 2015[186KB] December 1, 2017
　Corr. 2 October 26, 2016[24.3KB] December 1, 2017
　Corr. of Sign-off cover sheet November 15, 2021[26.4KB] -
　Corr. 3 January 20, 2023[1,222KB] June 28, 2024

 

  • E-21 / Hypromellose　ヒプロメロース
Harmonization No. Sign-off 施行日
　初回調和 November 10, 2003[131KB] April 1, 2006
　Rev. 1 June 6, 2012[30.6KB] February 28, 2014
　Rev. 1, Corr. 1 June 26, 2014[35.9KB] April 1, 2016
　Rev. 1, Corr. 2 July 1, 2015[231KB] December 1, 2017
　Rev. 1, Rev. of Sign-off cover sheet October 26, 2016[460KB] June 28, 2019
　Rev. 2 September 13, 2017[30.2KB] June 28, 2019
　Corr. of Sign-off cover sheet November 15, 2021[26.5KB] -
　Rev. 2, Corr. 1 January 20, 2023[1,927KB] June 28, 2024

 

  • E-22 / Hypromellose Phthalate　ヒプロメロースフタル酸エステル
Harmonization No. Sign-off 施行日
　初回調和 June 6, 2006[102KB] October 1, 2007
　Corr. 1 November 15, 2021[103KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[372KB] December 12, 2022

 

  • E-23 / Lactose, Anhydrous　無水乳糖
Harmonization No. Sign-off 施行日
　初回調和 September 10, 2002[35.3KB] -
　Rev. 1 February 5, 2003[35.0KB] April 1, 2006
　Rev. 2 November 8, 2005[118KB] October 1, 2007
　Rev. 3 June 5, 2008[30.4KB] October 1, 2009
　Rev. 4 November 9, 2010[55.5KB] October 1, 2012
　Rev. 4, Rev. of Sign-off cover sheet October 26, 2016[778KB] June 7, 2021
　Rev. 4, Corr. 1 October 2, 2019[29.6KB] June 7, 2021
　Rev. 4, Corr. 2 January 20, 2023[1,536KB] December 12, 2022
　Rev. 5 (Stage 1)  

 

  • E-24 / Lactose, Monohydrate　乳糖水和物
Harmonization No. Sign-off 施行日
　初回調和 September 10, 2002[115KB] April 1, 2006
　Rev. 1 October 25, 2006[127KB] -
　Rev. 2 June 5, 2008[36.2KB] October 1, 2009
　Rev. 2, Corr. 1 October 2, 2019[28.1KB] June 7, 2021
　Rev. 2, Corr. 2 January 20, 2023[874KB] December 12, 2022
　Rev. 3 (Stage 1)  

 

  • E-25 / Magnesium Stearate　ステアリン酸マグネシウム
Harmonization No. Sign-off 施行日
　初回調和 June 3, 2008[34.1KB] October 1, 2012
　Corr. 1 November 11, 2008[39.0KB] October 1, 2012
　Corr. 2 June 6, 2012[25.2KB] October 1, 2012
　Corr. 3 June 27, 2013[34.5KB] -
　Corr. of Sign-off cover sheet December 22, 2020[53.5KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[393KB] December 12, 2022

 

  • E-26 / Methylcellulose　メチルセルロース
Harmonization No. Sign-off 施行日
　初回調和 November 10, 2003[130KB] -
　Rev. 1 November 8, 2005[124KB] April 1, 2006
　Rev. 2 June 6, 2012[31.3KB] February 28, 2014
　Rev. 2, Corr. 1 June 26, 2014[18.6KB] April 1, 2016
　Rev. 2, Corr. 2 July 1, 2015[219KB] December 1, 2017
　Rev. 3 September 13, 2017[32.7KB] June 28, 2019
　Corr. of Sign-off cover sheet November 15, 2021[26.0KB] -
　Rev. 3, Corr. 1 January 20, 2023[1,884KB] June 28, 2024

 

  • E-27 / Methyl Paraben　パラオキシ安息香酸メチル
Harmonization No. Sign-off 施行日
　初回調和 February 19, 2004[112KB] April 1, 2006
　Rev. 1 June 10, 2009[27.8KB] October 1, 2012
　Rev. 1, Corr. 1 November 9, 2011[35.4KB] October 1, 2012
　Rev. 1, Corr. 2 December 22, 2020[152KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[387KB] December 12, 2022

 

  • E-28 / Petrolatum　黄色ワセリン
Harmonization No. Sign-off 施行日
　初回調和 November 15, 2021[203KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[423KB] December 12, 2022

 

  • E-29 / Petrolatum, White　白色ワセリン
Harmonization No. Sign-off 施行日
　初回調和 November 15, 2021[191KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[429KB] December 12, 2022

 

  • E-30 / Polyethylene Glycol　（調和作業中）

 

  • E-31 / Polysorbate 80　ポリソルベート80
Harmonization No. Sign-off 施行日
　初回調和 June 3, 2008[28.7KB] February 28, 2014
　Corr. 1 October 27, 2009[21.0KB] February 28, 2014
　Corr. 2 November 13, 2014[481KB] April 1, 2016
　Corr. 3 July 1, 2016[26.8KB] December 1, 2017
　Rev. of Sign-off cover sheet October 26, 2016[450KB] -
　Corr. of Sign-off cover sheet December 22, 2020[53.3KB] Decemer 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[436KB] Decemer 12, 2022

 

  • E-32 / Povidone　ポビドン
Harmonization No. Sign-off 施行日
　初回調和 October 25, 2006[116KB] April 1, 2016
　Corr. 1 May 8, 2007[78.3KB] April 1, 2016
　Corr. 2 June 3, 2008[30.6KB] April 1, 2016
　Rev. 1 July 1, 2015[361KB] April 1, 2016
　Rev. 1, Corr. 1 November 4, 2015[696KB] -
　Corr. of Sign-off cover sheet January 20, 2023[541KB] December 12, 2022
　Rev. 2 (Stage 1)  

 

  • E-36 / Silicon Dioxide　（調和作業中）

 

  • E-37 / Silicon Dioxide, Colloidal　（調和作業中）

 

  • E-38 / Sodium Chloride　塩化ナトリウム
Harmonization No. Sign-off 施行日
　初回調和 May 23, 2001[32.9KB] -
　Rev. 1 October 24, 2001[35.2KB] January 1, 2003
　Rev. 2 November 11, 2003[119KB] April 1, 2006
　Rev. 3 November 6, 2013[489KB] April 1, 2016
　Rev. 3, Corr. 1 May 26, 2016[433KB] -
　Rev. 3, Corr. 2 December 22, 2020[274KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[393KB] December 12, 2022

 

  • E-39 / Sodium Starch Glycolate　デンプングリコール酸ナトリウム
Harmonization No. Sign-off 施行日
　初回調和 November 10, 2003[37.6KB] -
　Rev. 1 May 11, 2005[110KB] October 1, 2007
　Rev. 3 June 27, 2013[38.2KB] April 1, 2016
　Corr. of Sign-off cover sheet November 15, 2021[27.6KB] -
　Corr. of Sign-off cover sheet January 20, 2023[376KB] December 12, 2022

 

  • E-40 / Starch, Corn　トウモロコシデンプン
Harmonization No. Sign-off 施行日
　初回調和 October 24, 2001[32.3KB] January 1, 2005
　Rev. 1 February 18, 2004[30.7KB] April 1, 2006
　Rev. 2 October 29, 2007[107KB] October 1, 2009
　Rev. 3 June 6, 2012[34.0KB] February 28, 2014
　Rev. 4 July 3, 2024[525KB] (April, 2026)

 

  • E-41 / Starch, Potato　バレイショデンプン
Harmonization No. Sign-off 施行日
　初回調和 October 24, 2001[32.8KB] January 1, 2005
　Rev. 1 October 29, 2007[106KB] October 1, 2009
　Rev. 2 June 15, 2011[46.9KB] February 28, 2014

 

  • E-42 / Starch, Rice　コメデンプン
Harmonization No. Sign-off 施行日
　初回調和 October 25, 2006[95.3KB] October 1, 2009
　Rev. 1 November 6, 2013[454KB] April 1, 2016

 

  • E-43 / Starch, Wheat　コムギデンプン
Harmonization No. Sign-off 施行日
　初回調和 October 24, 2001[32.6KB] January 1, 2005
　Rev. 1 October 29, 2007[111KB] October 1, 2009
　Rev. 2 June 15, 2011[46.1KB] April 1, 2011
　Rev. 2, Rev. of Sign-off cover sheet November 4, 2015[460KB] April 1, 2016
　Rev. 3 October 3, 2018[234KB] June 7, 2021
　Rev. 3, Corr. 1 December 22, 2020[261KB] December 12, 2022
　Corr. of Sign-off cover sheet November 15, 2021[30.0KB] -

 

  • E-44 / Stearic Acid　ステアリン酸
Harmonization No. Sign-off 施行日
　初回調和 June 3, 2008[32.1KB] February 28, 2014
　Rev. 1 November 6, 2013[468KB] February 28, 2014
　Rev. 1, Corr. 1 November 13, 2014[293KB] -
　Rev. 1, Rev. of Sign-off cover sheet July 1, 2015[356KB] April 1, 2016
　Rev. 2 November 15, 2021[376KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[391KB] December 12, 2022

 

  • E-45 / Sucrose　精製白糖
Harmonization No. Sign-off 施行日
　初回調和 October 30, 2007[107KB] October 1, 2012
　Rev. of Sign-off cover sheet June 27, 2013[32.9KB] -
　Rev. 1 (Stage 3A)  

 

  • E-46 / Talc　タルク
Harmonization No. Sign-off 施行日
　初回調和 November 10, 2003[147KB] -
　Rev. 1 June 3, 2008[33.6KB] April 1, 2011

 

  • E-48 / Ethyl Paraben　パラオキシ安息香酸エチル
Harmonization No. Sign-off 施行日
　初回調和 February 19, 2004[112KB] April 1, 2006
　Rev. 1 June 10, 2009[30.2KB] October 1, 2012
　Rev. 1, Corr. 1 November 9, 2011[35.0KB] October 1, 2012
　Rev. 1, Corr. 2 December 22, 2020[148KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[386KB] December 12, 2022

 

  • E-49 / Propyl Paraben　パラオキシ安息香酸プロピル
Harmonization No. Sign-off 施行日
　初回調和 February 19, 2004[111KB] April 1, 2006
　Rev. 1 June 10, 2009[30.0KB] October 1, 2012
　Rev. 1, Corr. 1 November 9, 2011[35.2KB] October 1, 2012
　Rev. 1, Corr. 2 December 22, 2020[144KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[381KB] December 12, 2022

 

  • E-50 / Butyl Paraben　パラオキシ安息香酸ブチル
Harmonization No. Sign-off 施行日
　初回調和 February 19, 2004[110KB] April 1, 2006
　Rev. 1 June 9, 2010[29.4KB] October 1, 2012
　Rev. 1, Corr. 1 December 22, 2020[179KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[377KB] December 12, 2022

 

  • E-51 / Glycerin　（調和作業中）

 

  • E-52 / Carmellose　カルメロース
Harmonization No. Sign-off 施行日
　初回調和 November 11, 2008[29.1KB] April 1, 2011
　Rev. 1 November 9, 2011[39.1KB] February 28, 2014
　Corr. of Sign-off cover sheet January 20, 2023[328KB] December 12, 2022

 

  • E-54 / Copovidone　コポビドン
Harmonization No. Sign-off 施行日
　初回調和 October 3, 2018[477KB] June 7, 2021
　Corr. 1 October 2, 2019[25.1KB] June 7, 2021
　Corr. of Sign-off cover sheet January 20, 2023[409KB] December 12, 2022
　Rev. 1 (Stage 1)  

 

  • E-55 / Gelatin　ゼラチン
Harmonization No. Sign-off 施行日
　初回調和 (gelling grade) June 6, 2012[37.0KB] May 31, 2013
　初回調和 (non-gelling grade) June 6, 2012[205KB] -
　Corr. 1 (gelling grade) November 7, 2012[28.7KB] May 31, 2013
　Corr. 1 (non-gelling grade) November 7, 2012[28.9KB] -
　Corr. 2 (gelling grade) November 6, 2013[529KB] April 1, 2016
　Corr. 2 (non-gelling grade) November 6, 2013[499KB] -
　Corr. 3 (gelling grade) October 26, 2016[653KB] June 7, 2021
　Corr. 3 (non-gelling grade) October 26, 2016[811KB] -
　Rev. 2 (gelling grade) October 3, 2018[204KB] June 7, 2021
　Rev. 2 (non-gelling grade) October 3, 2018[490KB] -
　初回調和 (gelling grade and non-gelling grade) October 2, 2019[18.7KB] June 7, 2021
　Corr. of Sign-off cover sheet (gelling grade and non-gelling grade) November 15, 2021[27.7KB] -
　Corr. of Sign-off cover sheet (gelling grade and non-gelling grade) January 20, 2023[382KB] December 12, 2022

（注）2019年10 月PDG東京会合議事要旨[357KB]で合意された通り、ゲル化グレード（E-55a）と非ゲル化グレード（E-55b）は統合されてE-55とされました。
 

  • E-56 / Glucose Anhydrous/Monohydrate　精製ブドウ糖／ブドウ糖水和物
Harmonization No. Sign-off 施行日
　初回調和 June 26, 2014[33.0KB] December 1, 2017
　Corr. 1 January 20, 2015[13.8KB] December 1, 2017
　Rev. of Sign-off cover sheet November 4, 2015[304KB] -
　Corr. of Sign-off cover sheet January 20, 2023[357KB] December 12, 2022

 

  • E-58 / Mannitol　D－マンニトール
Harmonization No. Sign-off 施行日
　初回調和 June 6, 2012[38.5KB] February 28, 2014
　Corr. 1 June 26, 2014[15.8KB] February 28, 2014
　Corr. of Sign-off cover sheet October 3, 2018[650KB] -
　Corr. of Sign-off cover sheet November 15, 2021[30.2KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[420KB] December 12, 2022

 

  • E-59 / Propylene Glycol　（調和作業中）

 

  • E-60 / Sodium Laurylsulfate　ラウリル硫酸ナトリウム
Harmonization No. Sign-off 施行日
　初回調和 November 13, 2014[452KB] December 1, 2017
　Rev. 1 October 2, 2019[17.7KB] June 7, 2021

 

  • E-61 / Starch, Pregelatinized　（調和作業中）

 

  • E-62 / Sterile Water for Injection in Containers　（調和作業中）

 

  • E-64 / Isomalt　イソマル水和物
Harmonization No. Sign-off 施行日
　初回調和 June 27, 2013[31.7KB] April 1, 2016
　Rev. of Sign-off cover sheet November 4, 2015[321KB] April 1, 2016
　Corr.1 November 29, 2016[233KB] June 28, 2019
　Corr. of Sign-off cover sheet October 3, 2018[455KB] -
　Corr. of Sign-off cover sheet January 20, 2023[356KB] December 12, 2022

 

  • E-65 / Isostearyl Alcohol　（調和作業中）

 

  • E-66 / Myristyl Myristate　（調和作業中）

 

  • E-68 / Polysorbate 65　（調和作業中）

 

  • E-69 / Calcium Silicate　（調和作業中）

 

  • E-70 / Polysorbate 20　（調和作業中）

 

  • E-71 / Purified Water　（調和作業中）

 

  • E-72 / Water for Injection　（調和作業中）
 

調和対象外項目

 以下2項目については、2018年10月に三薬局間調和作業計画の対象外とされました。
（詳しくは2018年10月PDGストラスブール会合議事要旨[306KB]をご参照ください。）
 

  • E-63 / Lactose for Inhalation
  • E-67 / Sodium Cetyl Sulfate
  

調和対象外項目

 以下5項目については、2017年9月に三薬局間調和作業計画の対象外とされました。
（詳しくは2017年9月PDGロックビル会合議事要旨[203KB]をご参照ください。）
 

  • E-12 / Cellulose Acetate
Harmonization No. Sign-off 施行日
　初回調和 October 24, 2001[108KB] -
　Rev. 1 February 5, 2003[107KB] -
　Rev. 2 November 7, 2012[32.5KB] -
　Rev. 3 July 21, 2016[226KB] -

 

  • E-33 / Saccharin　サッカリン
Harmonization No. Sign-off 施行日
　初回調和 February 5, 2003[106KB] April 1, 2006
　Rev. 1 June 27, 2013[30.8KB] April 1, 2016

 

  • E-34 / Saccharin, Sodium 　サッカリンナトリウム水和物
Harmonization No. Sign-off 施行日
　初回調和 February 5, 2003[33.4KB] -
　Rev. 1 February 18, 2004[114KB] April 1, 2006
　Rev. 2 November 13, 2014[501KB] December 1, 2017
　Rev. 2, Corr. 1 May 26, 2016[293KB] December 1, 2017
　Rev. 2, Sign-off cover sheet October 26, 2016[528KB] -

 

  • E-35 / Saccharin, Calcium
Harmonization No. Sign-off 施行日
　初回調和 February 5, 2003[105KB] -

 

  • E-53 / Calcium Carbonate