調和合意された試験法等について、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 November 24, 2023
| Harmonization Item | 日局収載名等 | Sign-off | 施行日 |
|---|---|---|---|
| Q-01 / Dissolution | <6.10> 溶出試験法 | ||
| 初回調和 | June 22, 2004 | April 1, 2006 | |
| Rev. 1 | November 8, 2005 | - | |
| Rev. 2 | November 12, 2008 | July 30, 2010 | |
| Rev. 3 | June 10, 2010 | October 1, 2010 | |
| Rev. 3, Corr. Sign-off cover sheet | October 3, 2018 | - | |
| Rev. 3, Corr. Sign-off cover sheet | October 2, 2019 | - | |
| Rev. 5 | |||
| Q-02 / Disintegration | <6.09> 崩壊試験法 | ||
| 初回調和 | June 21, 2004 | April 1, 2006 | |
| Rev. 1 | October 30, 2007 | March 31, 2009 | |
| Rev. 1, Corr.1 | October 3, 2018 | - | |
| Rev. 2 | |||
| Q-03/04 / Uniformity of Content/Mass | <6.02> 製剤均一性試験法 | ||
| 初回調和 | February 18, 2004 | April 1, 2006 | |
| Rev. 1 | November 9, 2010 | May 31, 2013 | |
| Rev. 1, Revised Sign-off cover sheet | June 15, 2011 | - | |
| Rev. 1, Rev. of Sign-off cover sheet | November 6, 2013 | - | |
| Rev. 2 | November 4, 2015 | December. 1, 2017 | |
| Rev. 2, Corr. 1 | October 26, 2016 | - | |
| Q-05a / Tests for Specified Microorganism | <4.05> 微生物限度試験法 | ||
| 初回調和 | November 8, 2005 | October 1, 2007 | |
| Rev. 1 | June 5, 2008 | March 31, 2009 | |
| Q-05b / Microbial Enumeration | <4.05> 微生物限度試験法 | ||
| 初回調和 | November 8, 2005 | October 1, 2007 | |
| Rev. 1 | June 5, 2008 | March 31, 2009 | |
| Rev. 1, Corr. 1 | June 10, 2009 | April 1, 2011 | |
| Rev. 1, Corr. 2 | August 22, 2023 | (April , 2026) | |
| Q-05c / Limits for Non-sterile Products | <G4-1-170> 非無菌医薬品の微生物学的品質特性 | ||
| 初回調和 | November 8, 2005 | October 1, 2007 | |
| Rev. of Sign-off cover sheet | June 27, 2013 | - | |
| Corr. of Sign-off cover sheet | October 3, 2018 | - | |
| Q-06 / Bacterial Endotoxins | <4.01> エンドトキシン試験法 | ||
| 初回調和 | January 3, 2000 | April 1, 2001 | |
| Rev. 1 | November 11, 2008 | April 1, 2011 | |
| Rev. 1, Corr. 1 | October 27, 2009 | April 1, 2011 | |
| Rev. 2 | June 15, 2011 | October 1, 2012 | |
| Q-07 / Color (instrumental method) | <G1-4-181> 液の色に関する機器測定法 （注）参考情報案に係る趣旨説明（2020年12月） |
||
| 初回調和 | October 26, 2016 | - | |
| Rev. 1 | June 24, 2019 | December 12, 2022 | |
| Q-08 / Extractable Volume | <6.05> 注射剤の採取容量試験法 | ||
| 初回調和 | July 18, 2000 | - | |
| Rev. 1 | June 10, 2004 | July 21, 2005 | |
| Update to Rev. 1, Sign-off cover sheet | November 9, 2010 | - | |
| Rev. 2 | |||
| Q-09 / Particulate Contamination | <6.07> 注射剤の不溶性微粒子試験法 （注）一般試験法改正案に係る趣旨説明（2021年9月） |
||
| 初回調和 | May 21, 2001 | - | |
| Rev. 1 | June 10, 2004 | April 1, 2006 | |
| Rev. 1, Sign-off cover sheet | November 9, 2010 | April 1, 2011 | |
| Update to Rev. 1, Sign-off cover sheet | June 6, 2012 | - | |
| Rev. 2 | |||
| Q-10 / Residue on Ignition | <2.44> 強熱残分試験法 | ||
| 初回調和 | February 11, 2000 | January 1, 2003 | |
| Rev. 1 | September 10, 2002 | January 1, 2005 | |
| Rev. 2 | August 4, 2005 | April 1, 2006 | |
| Q-11 / Sterility Test | <4.06> 無菌試験法 | ||
| 初回調和 | September 10, 2002 | January 1, 2005 | |
| Rev. 1 | October 30, 2007 | March 31, 2009 | |
| Rev. 1, Corr. 1 | June 3, 2008 | March 31, 2009 | |
| Rev. 1, Corr. 2 | November 11, 2008 | - | |
| Rev. 1, Corr. 3 | June 10, 2009 | April 1, 2011 | |
| G-01 / Analytical Sieving | <3.04> 粒度測定法 | ||
| 初回調和 | June 10, 2004 | April 1, 2006 | |
| Rev. 1 | May 8, 2007 | October 1, 2009 | |
| Rev. 1, Corr. 1 | November 15, 2021 | December 12, 2022 | |
| Rev. 2 | |||
| G-02 / Bulk Density of Powders | <3.01> かさ密度及びタップ密度測定法 | ||
| 初回調和 | May 8, 2007 | October 1, 2009 | |
| Rev. 1 | June 5, 2008 | October 1, 2009 | |
| Rev. 1, Corr. 1 | June 10, 2009 | April 1, 2011 | |
| Rev. 2 | June 15, 2011 | October 1, 2012 | |
| Rev. 3 | November 6, 2013 | October 1, 2012 | |
| Rev. 4 | January 20, 2023 | (June, 2024) | |
| Rev. 4, Corr. 1 | November 24, 2023 | (June, 2024) | |
| G-03 / Conductivity | <2.51> 導電率測定法 | ||
| 初回調和 | September 13, 2017 | June 28, 2019 | |
| Corr. 1 | October 2, 2019 | June 7, 2021 | |
| G-04 / Gas Pycnometric Density of Solids | <3.03> 粉体の粒子密度測定法 | ||
| 初回調和 | May 8, 2007 | October 1, 2009 | |
| G-05 / Powder Flow | <G2-3-171> 粉体の流動性 | ||
| 初回調和 | June 10, 2004 | April 1, 2006 | |
| Rev. 1 | January 20, 2023 | (June, 2024) | |
| G-06 / Tablet Friability | <G6-5-181> 錠剤の摩損度試験法 | ||
| 初回調和 | February 18, 2004 | April 1, 2006 | |
| Rev. 1 | June 7, 2022 | December 12, 2022 | |
| G-07 / Elemental Impurities | （調和作業中） （注）Stage 2 意見公募案に係る趣旨説明（2020年3月） |
||
| G-09 / Optical Microscopy | <3.04> 粒度測定法 | ||
| 初回調和 | June 10, 2004 | April 1, 2006 | |
| Rev. 1 | |||
| G-10 / Powder Fineness | <G2-2-171> 粉体の細かさの表示法 | ||
| 初回調和 | May 8, 2007 | October. 1, 2009 | |
| G-11 / Specific Surface Area | <3.02> 比表面積測定法 | ||
| 初回調和 | November 10, 2003 | April 1, 2006 | |
| G-13 / Laser Diffraction Measurement of Particle size | <3.06> レーザー回折・散乱法による粒子径測定法 | ||
| 初回調和 | November 11, 2008 | December 1, 2017 | |
| Rev. 1 | |||
| G-14 / X-Ray Powder Diffraction | <2.58> 粉末X線回折測定法 | ||
| 初回調和 | October 30, 2007 | April 1, 2011 | |
| Rev. 1 | December 22, 2020 | December 12, 2022 | |
| G-15 / Water-solid Interaction | <3.05> 収着-脱着等温線測定法及び水分活性測定法 | ||
| 初回調和 | October 27, 2009 | October 1, 2012 | |
| G-16 / Thermal Analysis | <2.52> 熱分析法 | ||
| 初回調和 | June 26, 2014 | April 1, 2016 | |
| Rev. 1 | |||
| G-20 / Chromatography | <2.00>クロマトグラフィー総論 （注）Stage 4 意見公募案に係る趣旨説明（2017年7月） （注）一般試験法に係る趣旨説明（2021年9月） |
||
| 初回調和 | September. 28, 2021 | December 12, 2022 | |
| Corr. 1 | November 13, 2023 | ||
| Rev. 1 | |||
| G-21 / Dynamic Light Scattering | （日局原案作成中） | ||
| 初回調和 | March 14, 2023 | (June, 2024) | |
| Corr. 1 | June 14, 2023 | (June, 2024) | |
| B-01 / Amino Acid Determination | <G3-2-171> アミノ酸分析法 | ||
| 初回調和 | September 9, 2002 | January 1, 2005 | |
| Rev. 1 | October 26, 2016 | December 1, 2017 | |
| B-02 / Capillary Electrophoresis | <G3-7-180> キャピラリー電気泳動法 | ||
| 初回調和 | September 10, 2002 | January 1, 2005 | |
| Corr. 1 | October 27, 2009 | - | |
| Corr. 2 | June 9, 2010 | July 20, 2010 | |
| Corr. 3 | November 20, 2018 | June 7, 2021 | |
| Rev. 1 | |||
| B-03 / Isoelectric Focusing | <G3-6-142> 等電点電気泳動法 | ||
| 初回調和 | September 9, 2002 | January 1, 2005 | |
| B-05 / Peptide Mapping | <G3-3-142> ペプチドマップ法 | ||
| 初回調和 | September 10, 2002 | January 1, 2005 | |
| Rev. 1 | January 20, 2023 | (June, 2024) | |
| B-06 / Polyacrylamide Gel Electrophoresis | <G3-8-170> SDSポリアクリルアミドゲル電気泳動法 | ||
| 初回調和 | October 15, 1999 | January 1, 2003 | |
| Rev. 1 | June 26, 2014 | April 1, 2016 |
以下6項目については、2017年9月に三薬局方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 Item | 日局収載名等 | Sign-off | 施行日 |
|---|---|---|---|
| G-08 / Inhalation | - | - | |
| G-12 / Porosimetry by Mercury Intrusion | May 8, 2007 | - | |
| G-17 / Uniformity of Delivered Dose of Inhalations | - | - | |
| G-18 / Microcalorimetry | June 15, 2011 | - | |
| G-19 / Density of Solids | - | - | |
| B-04 / Protein Determination | <G3-12-172> タンパク質定量法 | September 10, 2002 | - |