The Ministry of Health, Labour and Welfare of Japan, The Japanese Pharmacopoeia
, The Ministry of Health, Labour and Welfare of Japan, Tokyo, Japan, 17th edition, 2017, http://www.mhlw.go.jp/file/06-Seisakujouhou-11120000Iyakushokuhinkyoku/JP17_REV_1.pdf.
, Society of Japanese Pharmacopoeia
 The Japanese Pharmacopoeia
, the Electronic Version, 16th edition, 2011, http://jpdb.nihs.go.jp/jp16e/.
For instance, the subsection on purity in the Japanese pharmacopoeia
monograph for "ephedra herb" states, "The amount of the woody stems contained in Ephedra Herb does not exceed 5.0%." And in a subsection labeled Foreign Matter, "that Ephedra Herb does not contain stems of Equisetaceae or Gramineae plants, or any other foreign matter." These specifications define the identity of the material, "Ephedra Herb," and include not only the plant but also the plant part.
PRIOR TO 2006, THE UNITED STATES Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia
(JP) used test methods to ensure microbial safety of non-sterile pharmaceutical products that were similar in intent, but widely variable in execution and acceptance criteria.
The same medicinal parts of Herba Asari are also recorded in the Japanese Pharmacopoeia
. Moreover, the regulation of purity test described in the Japanese Pharmacopoeia
stating that the terrestrial parts such as leaves and petioles should not be prescribed (Society of Japanese Pharmacopoeia
International Standards Concerning Hot-Air Sterilization Sterilization Standard Temperature Period US Pharmacopoeia 170 C 120 min European Pharmacopoeia 160 C minimum 120 min minimum American Dental Association 160 C 120 min ANSI/AAMI ST63-D [greater than Not defined or equal to] 160 C ANSI/AAMI ST50 160 C 120 min DIN 58947 180 C 30 min Pharmacopoeia Nordica 180 C 30 min Hygiene Directive Robert Koch 160 C, 180 C 200 min or 30 Institute min Japanese Pharmacopoeia
160 C-170 C or 170 120 min or 60 C-180 C or 180 C-190 C min or 30 min British Pharmacopoeia 160 C minimum 60 min minimum
Japan: For submission to Japan, the Japanese Pharmacopoeia
(JP), Section 59, lists physicochemical and biological series testing.
The PDG is an informal body consisting of representatives from the European Pharmacopoeia (EP), the Japanese Pharmacopoeia
(JP), and USP.