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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) |