Appearance: Orange crystalline powder,no visible evidence ofcontamination by foreign material Identification A: The infrared sp…
Appearance:
Orange crystalline powder,no visible evidence of contamination by foreign material
Identification A:
The infrared spectrum exhibits maxima only at the same wavelengths as that of a similar preparation of the reference standard
Identification B:
The chromatogram of the assay preparation obtained in the
assay exhibits a major peak for idarubicin,the retention time
of which corresponds to that in the chromatogram of the
standard preparation
PH :5.0 ~ 6.5
Related Substances:
Single Impurities:≤0.15%
Total Impurities:≤3.0%
Water :≤5.0%
Methanol: ≤3000ppm
Ethanol :≤3000ppm
Methylene chloride :≤600ppm
Dioxane :≤380ppm
Bacterial endotoxins :≤8.9EU/mg
Sterility: Conforms to USP29
Assay :(anhydrous) 960~1030ug/mg(C26H27NO9 HCl)
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