《Table 1 Results of forced degradation study of MAC at different stressed conditions》

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《指示稳定性的高效液相色谱方法和强制降解研究片剂型马西替坦中的杂质（英文）》

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a) Po tency o f MAC in the respective stressed sam ple；b) net degradatio n=to tal im purities in stressed sam ple（%）-to tal im purities in unstressed sam ple（%）；c) m ass balance=po tency o f sam ple（%）+to tal degradatio n（%）；d) peak purity:purity a

Fo rced degradatio n o f MAC sam ples in the tablet do sage fo rm w as carried o ut using the standard ex perim ental pro cedure[31]sum m arized in Table 1 alo ng w ith the degraded pro duct.MAC degrades to fo ur kno w n im purities designated 1 to 4as sho w n in Fig.5.Am o ng the fo ur im purities，im purities 2 and 4 are degradatio n pro ducts o f MAC（Fig.6）and im purities 1 and 3 are pro cess related im purities during API synthesis.Fo rced degradatio n analyses sho w ed that MAC underw ent hydro lytic（acid and alkali），o x idative，and therm al（dry heat）degradatio n，but no t pho to lytic hum idity-related degradatio n.