Ganciclovir china manufacture 98.0%min CAS NO.82410-32-0

description

white crystalline odorless powder

identification

1.ir vs standard：the ir absorption spectrum of the preparation of the test specimen exhibits maxima only at the same wavelengths as that of a similar preparation of the standard .

2.uv vs standard：the uv absorption spectra of the test solution and the standard solution exhibit maxima and minima at the same wavelengths.

solubility

very slightly soluble in water

very soluble in dilute alkaline solutions

assay

not less than 98.0% and not more than 102.0% on dried basis

related substances

nomorethan0.5%ganciclovir

related compound a

no more than 1.5% for total impurities

organic remain

nomorethan0.3%carbinol

nomorethan0.088%dmf

nomorethan0.006%chloroform

water

no more than 6.0%

heavy metals

not more than 0.002%

residue on ignition

not more than 0.1%

bacterial endotoxins

0.3eundotoxin unit per mg

absorption index

e1%1cm516~548

microorganism

total bacterial count： max 100ufc/gram

fungus and /oryeast ：max 10ufc/gram

pathogens search：

e.coli： absent

p.aerugmosa： absent

s.aureus ：absent

salmonella：absent