PDG Stage 2 Official Inquiry

PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts

Japanese Pharmacopoeia (JP) participates in the PDG to work on pharmacopoeial harmonization of general chapters and excipient monographs. The PDG Stage 2 drafts are published to collect the opinions of the JP stakeholders. The guide for comment and the comment form are available on the Japanese version of JP website. The comments in Japanese submitted not later than the deadline will be considered for the preparation of the final version.
Note: The PDG stage number for official inquiry was changed from Stage 4 to Stage 2 on April 1, 2018 in compliance with the Working Procedures of the PDG, Revised version 2.0 signed off on September 13, 2017.

• March 2023 Publication (Due date: May 31, 2023) -Link to Japanese site
  • Corn Starch​
• December 2022 Publication (Due date: February 28, 2023) -Link to Japanese site 
  • Dissolution
• September 2021 Publication (Due date: November 30,2021) -Link to Japanese site
  • Particulate Contamination
• December 2020 Publication (Due date: February 28, 2021) -Link to Japanese site 
  • Tablet Friability
• September 2020 Publication (Due date: November 30,2020) -Link to Japanese site
  • Carboxymethylcellulose Sodium
  • Stearic Acid
  • Sucrose
• June 2020 Publication (Due date: August 31,2020) - Link to Japanese site
  • Particle size analysis by dynamic light scattering
• March 2020 Publication (Due date: May 31,2020) - Link to Japanese site
  • Elementral Impurities - Procedures 
  • Bulk Density of Powders
  • Powder Flow
• September 2019 Publication (Due date: November 30,2019) - Link to Japanese site
  • Croscarmellose Sodium
• March 2019 Publication (Due date: May 31,2019) - Link to Japanese site
  • Petrolatum
  • White Petrolatum
  • Sodium Lauryl Sulfate
• June 2018 Publication (Due date: August 31,2018) - Link to Japanese site
  • X-Ray Powder Diffraction (Revision 1)

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