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ITEMS 项目 |
SPECIFICATION (USP36) 标准 |
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DESCRIPTION 外观 |
WHITE OR ALMOST WHITE CRYSTALLINE POWDER 白色或几乎白色结晶性粉末 |
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IDENTIFICATION 鉴定 |
a)I.R.SPECTRUM b)By HPLC c)CHLORIDES |
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WATER CONTENT 水分 |
NOT MORE THAN 0.5％ (Using 0.4g) |
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RESIDUE ON IGNITION 灼烧残渣 |
NOT MORE THAN 0.1％ |
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HEAVY METALS 重金属 |
NOT MORE THAN 0.001％ |
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LIMIT OF DORZALAMIDE HCl RELATED COMPOUND “A” 限制盐酸多佐胺相关化合物的“ A ” |
NOT MORE THAN 0.5％ |
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CHROMATOGRAPHIC PURITY 色谱纯度 |
INDIVIDUAL IMPURITY: NOT MORE THAN 0.1％ 最大单一杂质不超过 TOTAL IMPURITIES: NOT MORE THAN 0.5％ 总杂质不超过 |
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ORGANIC VOLATILE IMPURITIES 溶媒残留 |
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(四氢呋喃):NOT MORE THAN 720ppm TOLUENE(甲苯): NOT MORE THAN 890ppm ISO PROPYL ALCOHOL(异丙醇):NOT MORE THAN 5000ppm CHLOROFORM(氯仿): NOT MORE THAN 60ppm DIOXANE(1,4-二氧六环): NOT MORE THAN 380ppm TRICHLOROETHYLENE(三氯乙烯):NOT MORE THAN 80ppm DICHLOROMETHANE(二氯甲烷): NOT MORE THAN 600ppm |
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ASSAY（ON ANHYDROUS BASIS） 含量 |
99.0％ ~ 101.0％ (C10H16N2O4S3.HCl) |
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