USP美国药典-NF 1503 英文 Quality Attributes of Synthetic Peptide Drug Substances.docxVIP

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USP美国药典-NF 1503 英文 Quality Attributes of Synthetic Peptide Drug Substances.docx

Printedon:TueAug302022,10:01:32am

Printedby:AlbertZhao

Status:CurrentlyOfficialon30-Aug-2022

OfficialDate:Officialasof01-Aug-2021

DocumentType:GENERALCHAPTER

DocId:GUID-36322BA3-3F12-4A80-9020-156D7EEBFB89_2_en-US

DOI:/10.31003/USPNF_M12935_02_01

DOIRef:r9xxs

?2022USPC

Addthefollowing:

▲〈1503〉QUALITYATTRIBUTESOFSYNTHETICPEPTIDEDRUGSUBSTANCES

INTRODUCTION

PEPTIDEDEFINITION

MANUFACTURINGMETHODS

RAWMATERIALS

PEPTIDEGENERALCHARACTERISTICSANDSPECIFICATION

ColorandAppearance

Identification

Bioassays

AssayandPeptideContent

Impuri

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