日本药典（19版）起草指南（英语版）2023.pdf

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GuidelineforDraftingMonographsfor

TheJapanesePharmacopoeia,

NineteenthEdition

(Partialrevision)

(Tentativetranslationversion*)

April2023

OfficeofReviewManagement

PharmaceuticalsandMedicalDevicesAgency

GuidelineforDraftingMonographsforTheJapanesePharmacopoeia,Nineteenth

Edition

(Partialrevision)

(Tentativetranslationversion)

Contents

1.Purpose···························································33.14Description··················································30

2.Content···························································33.15Descriptionofacrudedrug·······························34

3.Scope······························································33.16Identification················································34

4.Application······················································33.17Specificphysicaland/orchemicalvalues···············38

Part1Detailedrulesforpreparingadraftmonograph3.18Purity·························································43

forJP19······························································43.19Intentionaladulteration····································50

1.Basicitems······················································43.20Lossondrying,WaterorLossonignition·············50

1.1Establishmentofthespecificationsandtestprocedure··43.21Residueonignition,TotalashorAcid-insolubleash·52

1.1.1Selectionoftestitems············

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