药物杂质分析:甲氧氯普安杂质

应用领域:生物制药/仿制药

检测样品:甲氧氯普安

检测项目:甲氧氯普安杂质

参考标准:-

方案摘要

In the modern pharmaceutical industry,

it is critically important to identify and

quantify impurities with the highest

possible confidence given their potential

toxic effects on humans. This report

describes the performance of the

Agilent 6545 Q

-

TOF LC/MS system in

the determination of metoclopramide

pharmaceutical impurities.

In this, the 6545 Q

-

TOF and 1290

Infinity LC system are used to

determine metoclo

pramide impurities

(structures below).

Metoclopramide standard prepared at 500

ppm was spiked with all known impurities

described in European Pharmacopoeia and

two additional impurities at 0.05% (w/w)

and 0.01% (w/w) levels.

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