Esmolol hydrochloride 99%min Pharmaceutical Cardiovascular diseases made in china CAS NO.81161-17-3

appearance

white to off-white crystalline powder

no visible evidence of contamination by foreign matter

identification a

infrared absorption spectrumcorresponds to that of the reference standard

identification b

the rentention time of the sample preparation in the assay preparation corresponds to that of the standard preparation

melting point

87.5℃~91.0℃

ph

3.0~5.0

residue on ignition

≤0.1%

heavy metals

≤0.0020%

sulfate

≤0.030%

wate content

≤1.0%

related substance

any other individual unspecified impurity ≤0.1%

esmolol isopropylamide analog ≤0.25%

esmolol free acid ≤0.4%

esmolol dimer ≤0.5%

n-ethyl esmolol ≤0.15%

total impurities ≤1.0%

assay

98.0~10.2% calculated on the anhydrous basis

residual solvents

ethyl acetate ≤ 2500ppm

ethyl ether ≤ 200ppm

bacteria endotoxin

≤0.2eu/mg

bioburden

total microbial：≤ 100cfu/mg

total yeast&molds：≤50cfu/mg