Esomeprazole sodium China manufacture 99%min CAS NO.161796-78-7

description

white to an off-white powder ;hygroscopic in nature

solubility

freely soluble in water ,soluble in propylene glycol;sparingly soluble in alcohol and methanol

identification by

1. uv：0.002% solution in 0.1m naoh exhibits absorption maximum at 305nm and 276nm and the ratio is 1.6 to1.8
2. ir：the ir spectrum should be concordant with the ir spectrum of the working standard
3. test for sodium： the residue on ignition gives reaction of sodium

appearance of solution

(2.0 % w/v aqueous solution )

should be clear

ph

(2.0 % w/v aqueous solution )

10.3 to 11.3

water by kf (%w/w)

nmt 6.0%

specific rotation at 25 ℃(1.0% w/v solution in methanol)

-38 °~ –48.0°

heavy metals as pb

nmt20ppm

purity and related substances by hplc (%)

a) purity nlt 99.5%

b) total impurities nmt 0.5%

c) individual impurity nmt 0.2%

assay by hplc (% w/w)

(on anhydrous basis)

98.0 % to 102.0%

residual solvents by gc-hs (ppm)

a) methylene chloride nmt 600ppm

b) methanol nmt 3000ppm

c) ethyl acetate nmt 5000ppm

d) toluene nmt 890ppm