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Dorzolmide HCL USP36
ITEMSSPECIFICATIONDESCRIPTIONWHITE OR ALMOST WHITE CRYSTALLINE POWDERIDENTIFICATIONa)I.R.SPECTRUMb)By HPLCc)CHLORIDESWATER CONTENT水分NOT MORE THAN 0.5％ (Using 0.4g)RESIDUE ON IGNITIONNOT MORE THAN 0.1％HEAVY METALSNOT MORE THAN 0.001％LIMIT OF DOR…

 

ITEMS

SPECIFICATION

DESCRIPTION

WHITE OR ALMOST WHITE CRYSTALLINE POWDER

IDENTIFICATION

a)I.R.SPECTRUM

b)By HPLC

c)CHLORIDES

WATER CONTENT

水分

NOT MORE THAN 0.5％   (Using 0.4g)

RESIDUE ON IGNITION

NOT MORE THAN 0.1％

HEAVY METALS

NOT MORE THAN 0.001％

LIMIT OF DORZALAMIDE

HCl RELATED COMPOUND

“A”

NOT MORE THAN 0.5％

CHROMATOGRAPHIC PURITY

INDIVIDUAL IMPURITY: NOT MORE THAN 0.1％

TOTAL IMPURITIES: NOT MORE THAN 0.5％

ORGANIC VOLATILE

IMPURITIES

溶媒殘留

ACETONE(丙酮):          NOT MORE THAN 5000ppm

ACETONITRILE(乙腈):    NOT MORE THAN 410ppm

ETHYL ACETATE(乙酸乙酯):NOT MORE THAN 5000ppm

HEXANE(正已烷):          NOT MORE THAN 290ppm

METHANOL(甲醇):          NOT MORE THAN 3000ppm

TETRAHYDROFURAN(四氫呋喃):NOT MORE THAN 720ppm

TOLUENE(甲苯):           NOT MORE THAN 890ppm

ISO PROPYL ALCOHOL(異丙醇):NOT MORE THAN 5000ppm

CHLOROFORM(氯仿):        NOT MORE THAN 60ppm

DIOXANE(1,4-二氧六環(huán)):   NOT MORE THAN 380ppm

TRICHLOROETHYLENE(三氯乙烯):NOT MORE THAN  80ppm

DICHLOROMETHANE(二氯甲烷): NOT MORE THAN 600ppm

ASSAY

（ON ANHYDROUS BASIS）

99.0％ ~ 101.0％ (C10H16N2O4S3.HCl)