Function: | Antiviral and New Anti HIV Drugs |
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Certification: | GMP |
Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | Not Volatile |
Samples: |
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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) |
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