PRODUCT NAME:FLUCONAZOLE EP5.6

EXPIRY DATE:3 years

CAS NO.:

TEST ITEM

LIMT

TEST RESULTS

APPEARANCE

WHITE OR ALMOST WHITE,HYGROSCOPLE,CRYSTALLINE POWDER

CONFORMS

SOLUBILITY

SLIGHTLY SOLUBLE IN WATER,FREELY SOLUBLE IN METHANOL,SOLUBLE IN ACETONE

COMPLIES

IDENTIFICATION

TO COMPLY

COMPLIES

APPEARANCE OF SOLUTION

THE SOLUTION IS CLEAR AND COLORLESS

COMPLIES

RELATED SUBSTANCES %

IMPURITY A≤0.4

IMPURITY B≤0.3

IMPURITY C≤0.1

UNSPECIFIED IMPURITIES≤0.1

TOTAL IMPURITY≤0.6

0.3

NIL

NIL

0.02

0.32

HEAVY METALS %

≤0.001

<0.001

LOSS ON DRYING %

≤0.5

0.18

SULPHATED ASH %

≤0.1

<0.1

ASSAY (ON DRY BASIS) %

99.0-101.0

99.68

GRANULE SIZE

180 MICRON MAX

CONFORMS

CONCLUSION

CONFORMS TO EP5.6