Homoharringtonine
Omacetaxine mepesuccinate
Ceflatonin
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.
TEST ITEM SPECIFICATION RESULTS
Appearance Kind of white or
light yellow crystalline powder Kind of white crystalline Powder
Solubility Soluble in ethanol, methanol, Chloroform, Slightly soluble in water and ethyl ether Conform
Assay (HPLC) 95% -103% 99.45%
Melting Point 143C ¬-147C 144C-146C
Loss on Drying ≤2.0% 0.65%
Heavy Metals ≤20 ppm 10ppm
Total Impurities ≤2.0% 0.53%
Known single impurities ≤0.5% 0.28%
Unknown single impurities ≤0.1% 0.08%
Residual Solvent Meets the requirements of ICH Conform
Acetone ≤5000ppm 300ppm
Methanol ≤3000ppm 58ppm
Chloroform ≤5000ppm 400ppm
Dichloromethane ≤3000ppm Absence
Microbial Limits
Total aerobic microbial count ≤1000 cfu/g 60 cfu/g
Yeast & Mold Absence Absence
Salmonella species Absence Absence
Escherichia Coli Absence Absence
CONCLUSION Conform to the specifications