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CAS No:143491-57-0
Chemical Name:5-Fluoro-l-(2R,5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
Molecular Formula:C8H10FN3O3S
Shelf life:2 years
Storage Conditions:Store below 30℃
The detailed specifications are as below:

AppearanceWhite to off-white powder
Identity by chiral HPLCThe retention time of the main peak corresponds within 2.0% to that of the cis-(-)-EMTB reference standard
Identity by IRConsistent with the reference standard
Clarity of Solution (1%w/v in water)Clear, essentially free of visible particles
Water Content(%)≤0.5
Heavy Metals as lead(ppm)≤20
Residue on ignition(%)≤0.2
Bulk density(g/ml)Report data
Particle size by laser light scattering(μm)d50≤30
d90 :45〜75
Residual Solvent (%)Ethanol ≤1.00
Isopropyl Acetate≤0.20
1-propanol ≤1.00
Any unspecified solvent ≤0.10 or ≤the Permitted Daily Exposure specified by ICH Q3C.
EMTB-Carboxylic Acid(%)≤0.50
EMTB sulfoxides(%)≤0.15
Any unspecified impurity by HPLC(%)≤0.10
Total impurities by≤1.0
Assay by HPLC(%)98.0〜102.0 ( Dried basis)
98.0〜102.0 (Anhydrous basis)
Drug content factor (Report data)
Cis-(-) chiral purity by HPLC(%)Cis-(-)-EMTB≥98.5
cis-(+)-EMTB (Report data)
trans-(-)-EMTB (Report data)
 trans-(+)-EMTB(Report data)