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Items Specification
Appearance White or off white powder
Solubility Easy to dissolve in water
Identification HPLC
IR
Water 3.0%～5.0%
Heavy metals ≤20ppm
Residue on ignition ≤0.1%
Chiral impurities ≤1.0%
Specific rotation -18.0°~-23.0°(C=1,water)
Related impurities Total impurity≤1.0%
Assay 98.0%~102.0%
Conclusion Comply with In-house standard.
Sitagliptin phosphate monohydrate