Ketotifen fumarate

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Purity: 98.5%

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COMPLY WITH INHOUSE STANDARD PRODUCT KETOTIFEN FUMARATE EPVEXPIRY DATE 2 YEARSITEMSPECIFICATION(EPV)RESULTSAPPEARANCEWHITE TO BROWN…

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COMPLY WITH INHOUSE STANDARD PRODUCT KETOTIFEN FUMARATE EPVEXPIRY DATE 2 YEARS ITEMSPECIFICATION(EPV)RESULTSAPPEARANCEWHITE TO BROWNISH-YELLOW, FINE, CRYSTALLINE POWDERCONFORMSSOLUBILITYSPARINGLY SOLUBLE IN WATER,SLIGHTLY SOLUBLE IN METHANOL,VERY SLIGHTLY SOLUBLE IN ACETONITRILECONFORMSIDENTIFICATIONTLCCOMPLIESIR SPECTRUMCOMPLIESCLARITY AND COLOUR OF SOLUTIONCLEAR AND NOT MORE THAN Y4,BY4,B4<BY4LOSS ON DRYINGNOT MORE THAN 0.5%0.2%SULPHATED ASHNOT MORE THAN 0.1%<0.1%PH3.0-4.03.6CHLORIDENOT MORE THAN 150ppm<150ppmHEAVY METALSNOT MORE THAN 20ppm<20ppmRELATED SUBSTANCES(HPLC)IMPURITY AIMPURITY GSINGLE UNKNOWN IMPURITYTOTAL 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 BASISBETWEEN 98.5% AND 101.0%99.3%CONCLUSIONCONFORMS

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