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Pharmaceuticals and Medical Devices Agency (Japan) pmda.go.jp

[YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated

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PDG (Pharmacopoeial Discussion Group) Sign-off Cover Sheets (which provide information such as on harmonized provisions, non-harmonized provisions, and local requirements as well as the signatures of three pharmacopoeias) on the harmonized general chapters are listed. From the sign-offs on December 22, 2020, not only sign-off cover sheets but full texts of the harmonized documents are published. (See the PDG November 2020 Videoconference Meeting Highlights[119KB].)
The JP edition or supplement of each implementation date is shown in the table “Implementation date of JP Editions and Supplements[26.0KB]”

  • Q-01 / Dissolution　<6.10> Dissolution Test
  • Q-02 / Disintegration　<6.09> Disintegration Test
  • Q-03/04 / Uniformity of Content/Mass　<6.02> Uniformity of Dosage Units
  • Q-05a / Tests for Specified Microorganism　<4.05> Microbiological Examination of Non-sterile Products
  • Q-05b / Microbial Enumeration　<4.05> Microbiological Examination of Non-sterile Products
  • Q-05c / Limits for Non-sterile Products　<G4-1-170> Microbial Attributes of Non-sterile Pharmaceutical Products
  • Q-06 / Bacterial Endotoxins　<4.01> Bacterial Endotoxins Test
  • Q-07 / Color (instrumental method)　<G1-4-181> Instrumental Measurement of Coloration of Liquids
  • Q-08 / Extractable Volume　<6.05> Test for Extractable Volume of Parenteral Preparations
  • Q-09 / Particulate Contamination　<6.07> Insoluble Particulate Matter Test for Injections
  • Q-10 / Residue on Ignition　<2.44> Residue on Ignition Test
  • Q-11 / Sterility Test　<4.06> Sterility Test
  • G-01 / Analytical Sieving　<3.04> Particle Size Determination
  • G-02 / Bulk Density of Powders　<3.01> Determination of Bulk Density
  • G-03 / Conductivity　<2.51> Conductivity Measurement
  • G-04 / Gas Pycnometric Density of Solids　<3.03> Powder Particle Density Determination
  • G-05 / Powder Flow　<G2-3-182> Powder Flow
  • G-06 / Tablet Friability　<G6-5-181> Tablet Friability Test
  • G-07 / Elemental Impurities　(JP draft under development)
  • G-09 / Optical Microscopy　<3.04>Particle Size Determination

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    October 13, 2026 03:33
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