Voriconazole CAS NO.137234-62-9

product name: voriconazole

batch no.: 20150401

15

manufacturing date: 20150401

report date: 20150401

quantity: 50kg

items

standards

results

characteristic

description

a white or almost white crystalline powder

almost white crystalline powder

melting point

128 ～ 132℃

131 ～ 132℃

specific rotation

-55°～ -61°

-59.9°

identification

chemical method

it should be positive reaction

conforms

hplc

the retention time is concordant with reference standard

conforms

ir

ir spectrum agrees with reference standard

conforms

tests

loss on drying

not more than 0.5%

0.1%

residue on ignition

not more than 0.1%

0.05%

heavy metals

not more than 0.002%

conforms

chloride

not more than 0.02%

conforms

sulfate

not more than 0.02%

conforms

fluoride content

14.7 ～ 17.9%

16.8%

related substances

max individual impurity, nmt0.1%

0.01%

total impurities, nmt0.5%

0.02%

optical isomers

not more than 0.5%

not detected

chloroform

not more than 0.006%

0.0002%

dichloromethane

not more than 0.06%

not detected

methanol

not more than 0.3%

not detected

isopropyl alcohol

not more than 0.5%

0.04%

acetone

not more than 0.5%

not detected

assay

not less than 98.5%, calculated on dried basis

99.8%

conclusion: up to the requirements of ep7.3

exam: analyst: check: v