PRODUCT: KETOTIFEN FUMARATE EPV

EXPIRY DATE: 2 YEARS

ITEM

SPECIFICATION(EPV)

RESULTS

APPEARANCE

WHITE TO BROWNISH-YELLOW, FINE, CRYSTALLINE POWDER

CONFORMS

SOLUBILITY

SPARINGLY SOLUBLE IN WATER,SLIGHTLY SOLUBLE IN METHANOL,VERY SLIGHTLY SOLUBLE IN ACETONITRILE

CONFORMS

IDENTIFICATION

TLC

COMPLIES

IR SPECTRUM

COMPLIES

CLARITY AND COLOUR OF SOLUTION

CLEAR AND NOT MORE THAN Y4,BY4,B4

<BY4

LOSS ON DRYING

NOT MORE THAN 0.5%

0.2%

SULPHATED ASH

NOT MORE THAN 0.1%

<0.1%

PH

3.0-4.0

3.6

CHLORIDE

NOT MORE THAN 150ppm

<150ppm

HEAVY METALS

NOT MORE THAN 20ppm

<20ppm

RELATED SUBSTANCES(HPLC)

IMPURITY A

IMPURITY G

SINGLE UNKNOWN IMPURITY

TOTAL IMPURITIES

NOT MORE THAN 0.2%

NOT MORE THAN 0.2%

NOT MORE THAN 0.1%

NOT MORE THAN 0.5%

0.13%

N.D.

N.D.

0.13%

ASSAY (POTEDNTIOMETRIC TITRATION) CALCULATED ON THE DRIED BASIS

BETWEEN 98.5% AND 101.0%

99.3%

CONCLUSION:

CONFORMS