ItemsStandardsResultsAppearanceWhiteto off-white crystallinepowderCompliesEngraving Machine IdentificationBy IRCompliesBy HPLCCompliesSolubilityFreely soluble in DMSO(100mg/mL), practically insoluble in water and ethanol.CompliesMelting Point181ºC~185ºC181.5ºC~184.6ºCLoss on Drying≤1.00%0.28%Residue on Ignition≤0.10%0.07%HeavyMetals≤10ppmCompliesResidual SolventsEthanol: ≤5000ppmNDTHF: ≤5000ppmGuide Rail 500ppmDMF: ≤880ppm75ppmAcetonitrile: &leShaft ;5000ppm100ppmRelatedSubstancesAny single impurity: ≤0.10%0.08%Total impurities: ≤0.50%0.38%Assay
(HPLC basis on drying)99.0%~101.0%99.75%Bulk Density0.25g/mL~0.40g/mLCompliesReference StandardIn-house StandardConclusionThe productcompliedtoIn-housestandard.StoragePreserve in tight,light-resistant containers in a cool place