Product Name: Homoharringtonine
Othere Name: Omacetaxine mepesuccinate [USAN]; Ceflatonin; Myelostat; 4-methyl-cephalotaxin2-hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate; Cephalotaxine,4-methyl(2r)-2-hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioa; Cephalotaxine 4-methyl 2-hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate;
NSC 141633; BRN 5687925; CGX-635; Omapro; UNII-6FG8041S5B; 1-((1S,3aR,14bS)-2-Methoxy-1,5,6,8,9,14b-hexahydro-4H- cyclopenta(a)(1,3)dioxolo(4,5-h)pyrrolo(2,1-b)(3)benzazepin-1-yl) 4-methyl (2R)-2- hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate
CAS No.: 26833-87-4
Chemical Formula: C29H39NO9
Formula Weight: 545.62g/mol
Assay: 98%
Appearance: Off-white powder
Identification method: Mass, NMR
Applicaton: Omacetaxine/ Homoharringtoninefor the determination and identification, pharmacological experiments.
Pharmacological effect: Omacetaxine/ Homoharringtonine cycle non-specific antineoplastic agents. Depolymerize ribosome; inhibit protein synthesis; reduce mitotic index of he tumor; decrease nucleic acid content of tumor tissue; mainly used in clinical acute promyelocytic leukemia; acute monocytic leukemia, acute myeloid leukemia and malignant lyMelting Pointhoma; can also be used for chronic myeloid leukemia, polycythemia vera psychosis.
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TEST ITEM
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SPECIFICATION
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RESULTS
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Appearance
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Kind of white or
light yellow crystalline powder
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Kind of white crystalline Powder
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Solubility
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Soluble in ethanol, methanol, Chloroform, Slightly soluble in water and ethyl ether
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Conform
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Assay (HPLC)
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95% -103%
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99.45%
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Melting Point
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143°C -147°C
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144°C-146°C
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Loss on Drying
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≤2.0%
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0.65%
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Heavy Metals
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≤20 ppm
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10ppm
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Total Impurities
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≤2.0%
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0.53%
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Known single impurities
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≤0.5%
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0.28%
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Unknown single impurities
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≤0.1%
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0.08%
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Residual Solvent
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Meets the requirements of ICH
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Conform
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Acetone
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≤5000ppm
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300ppm
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Methanol
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≤3000ppm
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58ppm
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Chloroform
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≤5000ppm
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400ppm
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Dichloromethane
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≤3000ppm
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Absence
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Microbial Limits
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Total aerobic microbial count
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≤1000 cfu/g
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60 cfu/g
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Yeast & Mold
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Absence
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Absence
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Salmonella species
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Absence
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Absence
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Escherichia Coli
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Absence
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Absence
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CONCLUSION
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Conform to the specifications
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