ここから本文です。

日局におけるPDG調和文書への対応状況(医薬品各条)

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をご確認ください。

As of June 14, 2023

Harmonization No. / Item 日局収載名等 Sign-off 施行日
E-01 / Alcohol エタノール    
 初回調和 October 24, 2001 -
 Rev. 1 September 9, 2002 April 1, 2006
 Rev. 2 November 7, 2012 February 28, 2014
 Rev. 2, Corr. 1 June 27, 2013 April 1, 2016
 Rev. 2, Corr. 2 June 26, 2014 April 1, 2016
 Corr. of Sign-off cover sheet November 15, 2021 December 12, 2022
E-02 / Dehydrated Alcohol 無水エタノール    
 初回調和 October 24, 2001 -
 Rev. 1 September 9, 2002 April 1, 2006
 Rev. 2 November 7, 2012 February 28, 2014
 Rev. 2, Corr. 1 June 27, 2013 April 1, 2016
 Rev. 2, Corr. 2 June 26, 2014 April 1, 2016
 Corr. of Sign-off cover sheet November 15, 2021 December 12, 2022
E-03 / Benzyl Alcohol ベンジルアルコール    
 初回調和 July 18, 2000 January 1, 2005
 Rev. 1 November 8, 2005 April 1, 2006
 Rev. 2 June 3, 2008 April 1, 2011
 Rev. 2, Corr. 1 June 15, 2011 October 1, 2012
 Rev. 2, Corr. 2 December 22, 2020 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    
 初回調和 November 8, 2005 February 28, 2014
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
 Rev. 1    
E-05 / Calcium Phosphate Dibasic リン酸水素カルシウム水和物    
 初回調和 November 8, 2005 October 1, 2007
 Rev. 1 June 15, 2011 October 1, 2012
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-06 / Calcium Phosphate Dibasic  Anhydrous 無水リン酸水素カルシウム    
 初回調和 November 8, 2005 October 1, 2007
 Rev. 1 June 15, 2011 October 1, 2012
 Rev. 2 September 13, 2017 June 28, 2019
 Corr. of Sign-off cover sheet November 15, 2021 -
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-07 / Carmellose Calcium カルメロースカルシウム    
 初回調和 October 24, 2001 -
 Rev. 1 July 17, 2003 January 1, 2005
 Rev. 1, Corr. 1 January 20, 2023 (June, 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    
 初回調和 October 24, 2001 April 1, 2006
 Rev. of Sign-off cover sheet May 26, 2016 December 12, 2022
 Rev. 1 December 22, 2020 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
 Rev. 2    
E-10 / Cellulose, Microcrystalline 結晶セルロース
 
   
 初回調和 February 18, 2004 -
 Rev. 1 May 11, 2005 April 1, 2006
 Rev. 1, Rev. of Sign-off cover sheet May 26, 2016 June 28, 2019
 Rev. 2 September 13, 2017 June 28, 2019
 Rev. 3 October 3, 2018 June 28, 2019
 Corr. of Sign-off cover sheet November 15, 2021 -
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-11 / Cellulose, Powdered 粉末セルロース    
 初回調和 February 18, 2004 -
 Rev. 1 May 11, 2005 April 1, 2006
 Rev. 1, Rev. of Sign-off Cover Sheet May 26, 2016 December 12, 2022
 Rev. 1, Corr. 1 November 15, 2021 -
 Rev. 1, Corr. 1 January 20, 2023 December 12, 2022
E-13 / Cellulose Acetate Phthalate セラセフェート    
 初回調和 October 24, 2001 January 1, 2005
 Rev. 1 November 9, 2010 October 1, 2012
 Rev. 1, Corr. 1 June 6, 2012 October 1, 2012
 Corr. of Sign-off cover sheet November 15, 2021 -
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-14 / Citric Acid, Anhydrous 無水クエン酸    
 初回調和 May 23, 2001 January 1, 2003
 Rev. 1 November 11, 2003 April 1, 2006
 Rev. 2 June 9, 2010 October 1, 2012
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-15 / Citric Acid, Monohydrate クエン酸水和物    
 初回調和 May 23, 2001 January 1, 2003
 Rev. 1 November 11, 2003 April 1, 2006
 Rev. 2 June 9, 2010 October 1, 2012
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-16 / Crospovidone クロスポビドン    
 初回調和 November 9, 2010 October 1, 2012
 Corr. of Sign-off cover sheet October 3, 2018 -
 Corr. of Sign-off cover sheet November 15, 2021 -
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-17 / Ethylcellulose エチルセルロース    
 初回調和 February 6, 2002 -
 Rev. 1 October 27, 2009 -
 Rev. 2 May 26, 2016 June 28, 2019
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-18 / Hydroxyethylcellulose ヒドロキシエチルセルロース    
 初回調和 July 25, 2016 June 28, 2019
 Corr. of Sign-off cover sheet November 15, 2021 -
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
 Rev. 1    
E-19 / Hydroxypropylcellulose ヒドロキシプロピルセルロース    
 初回調和 June 27, 2013 April 1, 2016
 Rev. of Sign-off cover sheet September 13, 2017 June 28, 2019
 Corr. of Sign-off cover sheet November 15, 2021 -
 Corr. of Sign-off cover sheet January 20, 2023 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    
 初回調和 November 13, 2014 December. 1, 2017
 Corr. 1 July 1, 2015 December. 1, 2017
 Corr. 2 October 26, 2016 December. 1, 2017
 Corr. of Sign-off cover sheet November 15, 2021 -
 Corr. 3 January 20, 2023 (June, 2024)
E-21 / Hypromellose ヒプロメロース    
 初回調和 November 10, 2003 April 1, 2006
 Rev. 1 June 6, 2012 February 28, 2014
 Rev. 1, Corr. 1 June 26, 2014 April 1, 2016
 Rev. 1, Corr. 2 July 1, 2015 December 1, 2017
 Rev. 1, Rev. of Sign-off cover sheet October 26, 2016 June 28, 2019
 Rev. 2 September 13, 2017 June 28, 2019
 Corr. of Sign-off cover sheet November 15, 2021 -
 Rev. 2, Corr. 1 January 20, 2023 (June, 2024)
E-22 / Hypromellose Phthalate ヒプロメロースフタル酸エステル    
 初回調和 June 6. 2006 October 1, 2007
 Corr. 1 November 15, 2021 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-23 / Lactose, Anhydrous 無水乳糖    
 初回調和 September 10, 2002 -
 Rev. 1 February 5, 2003 April 1, 2006
 Rev. 2 November 8, 2005 October 1, 2007
 Rev. 3 June 5, 2008 October 1, 2009
 Rev. 4 November 9, 2010 October 1, 2012
 Rev. 4, Rev. of Sign-off cover sheet October 26, 2016 June 7, 2021
 Rev. 4, Corr. 1 October 2, 2019 June 7, 2021
 Rev. 4, Corr. 2 January 20, 2023 December 12, 2022
 Rev. 5    
E-24 / Lactose, Monohydrate 乳糖水和物    
 初回調和 September 10, 2002 April 1, 2006
 Rev. 1 October 25, 2006 -
 Rev. 2 June 5, 2008 October 1, 2009
 Rev. 2, Corr. 1 October 2, 2019 June 7, 2021
 Rev. 2, Corr. 2 January 20, 2023 December 12, 2022
 Rev. 3    
E-25 / Magnesium Stearate ステアリン酸マグネシウム    
 初回調和 June 3, 2008 October 1, 2012
 Corr. 1 November 11, 2008 October 1, 2012
 Corr. 2 June 6, 2012 October 1, 2012
 Corr. 3 June 27, 2013 -
 Corr. of Sign-off cover sheet December 22, 2020 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-26 / Methylcellulose メチルセルロース    
 初回調和 November 10, 2003 -
 Rev. 1 November 8, 2005 April 1, 2006
 Rev. 2 June 6, 2012 February 28, 2014
 Rev. 2, Corr. 1 June 26, 2014 April 1, 2016
 Rev. 2, Corr. 2 July 1, 2015 December 1, 2017
 Rev. 3 September 13, 2017 June 28, 2019
 Corr. of Sign-off cover sheet November 15, 2021 -
 Rev. 3, Corr. 1 January 20, 2023 (June, 2024)
E-27 / Methyl Paraben パラオキシ安息香酸メチル    
 初回調和 February 19, 2004 April 1, 2006
 Rev. 1 June 10, 2009 October 1, 2012
 Rev. 1, Corr. 1 November 9, 2011 October 1, 2012
 Rev. 1, Corr. 2 December 22, 2020 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-28 / Petrolatum 黄色ワセリン    
 初回調和 November 15, 2021 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-29 / Petrolatum, White 白色ワセリン    
 初回調和 November 15, 2021 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-30 / Polyethylene Glycol (調和作業中)    
E-31 / Polysorbate 80 ポリソルベート80    
 初回調和 June 3, 2008 February 28, 2014
 Corr. 1 October 27, 2009 February 28, 2014
 Corr. 2 November 13, 2014 April 1, 2016
 Corr. 3 July 1, 2016 December 1, 2017
 Rev. of Sign-off cover sheet October 26, 2016 -
 Corr. of Sign-off cover sheet December 22, 2020 Decemer 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 Decemer 12, 2022
E-32 / Povidone ポビドン    
 初回調和 October 25, 2006 April 1, 2016
 Corr. 1 May 8, 2007 April 1, 2016
 Corr. 2 June 3, 2008 April 1, 2016
 Rev. 1 July 1, 2015 April 1, 2016
 Rev. 1, Corr. 1 November 4, 2015 -
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
 Rev. 2    
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    
 初回調和 May 23, 2001 -
 Rev. 1 October 24, 2001 January 1, 2003
 Rev. 2 November 11, 2003 April 1, 2006
 Rev. 3 November 6, 2013 April 1, 2016
 Rev. 3, Corr. 1 May 26, 2016 -
 Rev. 3, Corr. 2 December 22, 2020 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-39 / Sodium Starch Glycolate デンプングリコール酸ナトリウム    
 初回調和 November 10, 2003 -
 Rev. 1 May 11, 2005 October 1, 2007
 Rev. 3 June 27, 2013 April 1, 2016
 Corr. of Sign-off cover sheet November 15, 2021 -
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-40 / Starch, Corn トウモロコシデンプン    
 初回調和 October 24, 2001 January 1, 2005
 Rev. 1 February 18, 2004 April 1, 2006
 Rev. 2 October 29, 2007 October 1, 2009
 Rev. 3 June 6, 2012 February 28, 2014
 Rev. 4    
E-41 / Starch, Potato バレイショデンプン    
 初回調和 October 24, 2001 January 1, 2005
 Rev. 1 October 29, 2007 October 1, 2009
 Rev. 2 June 15, 2011 February 28, 2014
E-42 / Starch, Rice コメデンプン    
 初回調和 October 25, 2006 October 1, 2009
 Rev. 1 November 6, 2013 April 1, 2016
E-43 / Starch, Wheat コムギデンプン    
 初回調和 October 24, 2001 January 1, 2005
 Rev. 1 October 29, 2007 October 1, 2009
 Rev. 2 June 15, 2011 April 1, 2011
 Rev. 2, Rev. of Sign-off cover sheet November 4, 2015 April 1, 2016
 Rev. 3 October 3, 2018 June 7, 2021
 Rev. 3, Corr. 1 December 22, 2020 December 12, 2022
 Corr. of Sign-off cover sheet November 15, 2021 -
E-44 / Stearic Acid ステアリン酸    
 初回調和 June 3, 2008 February 28, 2014
 Rev. 1 November 6, 2013 February 28, 2014
 Rev. 1, Corr. 1 November 13, 2014 -
 Rev. 1, Rev. of Sign-off cover sheet July 1, 2015 April 1, 2016
 Rev. 2 November 15, 2021 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-45 / Sucrose 精製白糖    
 初回調和 October 30, 2007 October 1, 2012
 Rev. of Sign-off cover sheet June 27, 2013 -
 Rev. 1    
E-46 / Talc タルク    
 初回調和 November 10, 2003 -
 Rev. 1 June 3, 2008 April 1, 2011
E-48 / Ethyl Paraben パラオキシ安息香酸エチル    
 初回調和 February 19, 2004 April 1, 2006
 Rev. 1 June 10, 2009 October 1, 2012
 Rev. 1, Corr. 1 November 9, 2011 October 1, 2012
 Rev. 1, Corr. 2 December 22, 2020 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-49 / Propyl Paraben パラオキシ安息香酸プロピル    
 初回調和 February 19, 2004 April 1, 2006
 Rev. 1 June 10, 2009 October 1, 2012
 Rev. 1, Corr. 1 November 9, 2011 October 1, 2012
 Rev. 1, Corr. 2 December 22, 2020 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-50 / Butyl Paraben パラオキシ安息香酸ブチル    
 初回調和 February 19, 2004 April 1, 2006
 Rev. 1 June 9, 2010 October 1, 2012
 Rev. 1, Corr. 1 December 22, 2020 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-51 / Glycerin (調和作業中)    
E-52 / Carmellose カルメロース    
 初回調和 November 11, 2008 April 1, 2011
 Rev. 1 November 9, 2011 February 28, 2014
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-54 / Copovidone コポビドン    
 初回調和 October 3, 2018 June 7, 2021
 Corr. 1 October 2, 2019 June 7, 2021
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
 Rev. 1    
E-55a / Gelatin, gelling type ゼラチン    
 初回調和 June 6, 2012 May 31, 2013
 Corr. 1 November 7, 2012 May 31, 2013
 Corr. 2 November 6, 2013 April 1, 2016
 Corr. 3 October 26, 2016 June 7, 2021
 Rev. 2 October 3, 2018 June 7, 2021
E-55b / Gelatin, non-gelling grade (日局は調和に不参加)    
 初回調和 June 6, 2012 -
 Corr. 1 November 7, 2012 -
 Corr. 2 November 6, 2013 -
 Corr. 3 October 26, 2016 -
 Rev. 2 October 3, 2018 -
E-55 / Gelatin ゼラチン    
 Rev. 3 October 2, 2019 June 7, 2021
 Corr. of Sign-off cover sheet November 15, 2021 -
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-56 / Glucose Anhydrous/Monohydrate 精製ブドウ糖/ブドウ糖水和物    
 初回調和 June 26, 2014 December 1, 2017
 Corr. 1 January 20, 2015 December 1, 2017
 Rev. of Sign-off cover sheet November 4, 2015 -
 Corr. of Sign-off cover sheet January 20, 2023 December 12, 2022
E-58 / Mannitol D-マンニトール    
 初回調和 June 6, 2012 February 28, 2014
 Corr. 1 June 26, 2014 February 28, 2014
 Corr. of Sign-off cover sheet October 3, 2018 -
 Corr. of Sign-off cover sheet November 15, 2021 December 12, 2022
 Corr. of Sign-off cover sheet January 20, 2023 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    
 初回調和 November 13, 2014 December 1, 2017
 Rev. 1 October 2, 2019 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    
 初回調和 June 27, 2013 April 1, 2016
 Rev. of Sign-off cover sheet November 4, 2015 April 1, 2016
 Corr.1 November 29, 2016 June 28, 2019
 Corr. of Sign-off cover sheet October 3, 2018 -
 Corr. of Sign-off cover sheet January 20, 2023 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)    


 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をご参照ください。)

Harmonization No. / Item 日局収載名等 Sign-off 施行日
E-63 / Lactose for Inhalation   - -
E-67 / Sodium Cetyl Sulfate   - -


 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をご参照ください。)

Harmonization No. / Item 日局収載名等 Sign-off 施行日
E-12 / Cellulose Acetate      
 初回調和 October 24, 2001 -
 Rev. 1 February 5, 2003 -
 Rev. 2 November 7, 2012 -
 Rev. 3 July 21, 2016 -
E-33 / Saccharin サッカリン    
 初回調和 February 5, 2003 April 1, 2006
 Rev. 1 June 27, 2013 April 1, 2016
E-34 / Saccharin, Sodium サッカリンナトリウム水和物    
 初回調和 February 5, 2003 -
 Rev. 1 February 18, 2004 April 1, 2006
 Rev. 2 November 13, 2014 December 1, 2017
 Rev. 2, Corr. 1 May 26, 2016 December 1, 2017
 Rev. 2, Sign-off cover sheet October 26, 2016 -
E-35 / Saccharin, Calcium   February 5, 2003 -
E-53 / Calcium Carbonate   - -

 

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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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