Semaglutide Delivery Excipient Salcaprozate Sodium Cas No: 203787-91-1

Appearance: White to yellowish or pinkish crystalline powder; HPLC: The retention time of the main peak of the Sample solution corresponds to that of the Standard solution; UV: The maximum absorption should be at the wavelength of 301nm and 238nm , and the minimum absorption should be at the wavelength of 228nm; IR: Corresponding to Cholesterol CRS; Impurity A: Not more than 0.15%; Impurity E: Not more than 0.15%; Impurity G: Not more than 0.5%; The maximum unknown single impurity: Not more than 0.1%; Total impurities: Not more than 1.0%; Water: Not more than 2.0%; Heavy Metals: Not more than 0.002%; Arsenate: Not more than 0.0002%; Methyl Alcohol: Not more than 0.5%; Isopropanol: Not more than 0.5%; DMF: Not more than 0.088%; Ethyl Alcohol: Not more than 0.5%; Benzene: Not more than 0.0002%; Total Aerobic Microbial Count: Not more than 1000CFU/g; Total combined Yeasts & Moulds Count: Not more than 100CFU/g; Escherichia coli: Not detected; Residue on Ignition: Not more than 0.1%w/w; Sodium: 7.1% 8.1%(On the Anhydrous Basis); Salcaprozate Sodium: 98.0% 102.0%(On the Anhydrous Basis)