| Chemical Name | 5-Fluoro-l-(2R,5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine |
| Structural Formula |  |
| Items | Standard |
| Appearance | White to off-white powder |
| Identity by chiral HPLC | The retention time of the main peak corresponds within 2.0% to that of the cis-(-)-EMTB reference standard |
| Identity by IR | Consistent 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 |
| Methanol≤0.20 |
| Isopropyl Acetate≤0.20 |
| 1-propanol≤1.00 |
| Any unspecified solvent ≤0.10 or ≤the Permitted Daily Exposure specified by ICH Q3C. |
| EMTB-Dioxolane(%) | ≤0.70 |
| EMTB-Carboxylic Acid(%) | ≤0.50 |
| EMTB-Disulfide(%) | ≤0.30 |
| 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) |