硫代苹果酸钠金相关杂质检测方法及.pdfVIP

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硫代苹果酸钠金相关杂质检测方法及.pdf

3360Glycopyrrolate/MonographsUSP35

SolutionA:Acetonitrile,methanol,andBuffer(20:15:65)Acceptancecriteria:SeeTable2.

SolutionB:Acetonitrile,methanol,andBuffer(50:15:35)

Mobilephase:SeeTable1.Table2

RelativeAcceptance

Table1

RtentionCriteria,

TimeSolutionA

SolutionBNameTimeNMT(%)

(min)(%)(%)5-Nitroisophthalicacida0.45—d

01000Glycopyrrolate1.00—

101000Glycopyrrolatebaseb1.14—d

251090Cyclopentylmandelicacidc

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