Biapenem 98%min supplier Pharmaceutical API Antibiotic Antifungal drugs made in china CAS NO.120410-24-4

appearance

white to light yellow crystalline powder, odourless. slightly soluble in water ,almost insoluble in methanol, ethanol and acetonitrile

identification

chemical reaction

uv

ir

piositive

should have the largest wavelength absorption at 292-296 nm

shall conform to the reference substance of the solution

optical rotation

-28°~ -35°

ph

4.0-6.0

clarity and color of solution

conforms

related substance

total impurities

≤1.0%

the biggest single impurity

≤0.5%

biapenem polymer

≤0.5%

methanol

≤0.3%

acetone

≤0.3%

acetonitrile

≤0.041%

dichloromethane

≤0.06%

tetrahydrofuran

≤0.072%

loss on drying

≤0.5%

residue on ignition

≤0.2%

heavy metals

≤10ppm

visible foreign matter

conforms

insoluble particle

conforms

sterility

conforms

bacterial endotoxin

<0.5eu/ mg

assay

98.0-102.0% of biapenemon the dried basis