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:
| 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) |