- PRODUCT NAME:Sofosbuvir
Sofosbuvir is an antiviral medication used primarily in the treatment of chronic hepatitis C virus (HCV) infection. It belongs to a class of drugs known as direct-acting antivirals (DAAs), which target specific steps in the viral replication process, inhibiting the virus's ability to multiply and spread within the body.
Sofosbuvir is administered orally and is often prescribed in combination with other antiviral medications to form a highly effective treatment regimen for different genotypes of hepatitis C. The combination therapy helps improve treatment outcomes and increases the chances of achieving sustained virologic response (SVR), which means the virus is no longer detectable in the bloodstream.
This medication is well-tolerated by most patients and has been considered a significant advancement in the field of HCV treatment, offering high cure rates with shorter treatment durations compared to older interferon-based therapies.
Key features and benefits of Sofosbuvir:
1:High Efficacy: Sofosbuvir has shown high cure rates, often exceeding 90%, in various clinical trials and real-world studies when used in combination with other appropriate medications.
2:Genotype Coverage: It is effective against several genotypes of the hepatitis C virus, making it a versatile treatment option for a broader range of patients.
3:Well-Tolerated: Sofosbuvir-based regimens are generally well-tolerated, with a lower risk of side effects compared to older HCV treatments.
4:Shorter Treatment Duration: The use of Sofosbuvir-based regimens often allows for shorter treatment durations, typically ranging from 8 to 24 weeks, depending on the specific genotype and individual patient factors.
5:Convenience: As an oral medication, Sofosbuvir offers greater convenience for patients compared to injectable therapies.
|
Tests |
Specifications |
Results |
|
Appearance |
White or off-white crystalline powder |
White crystalline powder |
|
Identification |
A.Retention Time: Similar to Reference Substance |
Complies |
|
B.The 30 μg/ml methanol solution of this product has the maximum absorption at the wavelength of 262 nm |
Complies |
|
|
C.IR: Similar to Reference Substance |
Complies |
|
|
D.The X-ray diffraction patterns of this product (measurement range: 30～ 40°)have diffraction peaks at 2 theta as follows: 6.2°±0.2°、 8.2°士0.2°、10.4°±0.2°、12.7°±0.2°and 20.8°±0.2°, |
Complies |
|
|
Specific Rotation |
+34°~+38° |
+37° |
|
Melting Range |
123℃~127℃ |
123℃~127℃ |
|
Water |
≤0.5% |
0.13% |
|
Heavy metal |
≤20ppm |
Complies |
|
Related substances I |
DiSFBMA-SFB≤0.15% |
0.05% |
|
SFBA-1≤0.15% |
Not Detected |
|
|
phenol≤0.15% |
Not Detected |
|
|
Impurity A of SFB≤0.15% |
Not Detected |
|
|
Impurity B of SFB≤0.15% |
Not Detected |
|
|
Impurity C of SFB≤0.15% |
Not Detected |
|
|
Impurity D of SFB≤0.15% |
Not Detected |
|
|
Chloro-SFB≤0.15% |
Not Detected |
|
|
SFBD3≤0.15% |
Not Detected |
|
|
2-hydroxymethyl SFB≤0.15% |
Not Detected |
|
|
Any unknown impurity ≤0.10% |
0.02% |
|
|
Total impurities ≤0.5% |
0.09% |
|
|
Related substances Ⅱ |
SFBMA≤0.15% |
Not Detected |
|
Enantiomer |
SFBE≤0.15% |
0.03% |
|
Pentafluorophenol |
≤0.10% |
0.02% |
|
Genotoxic Impurities |
Sum of 1,4-dichlorobutane and 4-chloro-1-butanol≤3.75ppm |
Not Detected |
|
Residual solvents I |
Methanol≤3000ppm |
Not Detected |
|
Residual solvents I |
Ethanol≤5000ppm |
Not Detected |
|
Isopropyl alcohol≤5000ppm |
Not Detected |
|
|
Dichloromethane≤600ppm |
Not Detected |
|
|
Methyl tert-butyl ether≤5000ppm |
Not Detected |
|
|
N-Hexane≤290ppm |
Not Detected |
|
|
Isopropyl ether≤5000ppm |
Not Detected |
|
|
Ethyl acetate≤5000ppm |
Not Detected |
|
|
Tetrahydrofuran≤720ppm |
Not Detected |
|
|
Toluene≤890ppm |
Not Detected |
|
|
Chlorobenzene≤360ppm |
Not Detected |
|
|
N-Methylpyrrolidone≤530ppm |
Not Detected |
|
|
Residual solvents Ⅱ |
Benzene≤2ppm |
Not Detected |
|
Assay |
98.5%～101.0%(Calculated on the anhydrous basis) |
99.3% |
|
Tests |
Specifications |
Results |
|
Appearance |
White or off-white crystalline powder |
White crystalline powder |
|
Identification |
A. Retention Time: Similar to Reference Substance |
Complies |
|
B.The 30 μg/ml methanol solution of this product has the maximum absorption at the wavelength of 262 nm. |
Complies |
|
|
C.IR: Similar to Reference Substance |
Complies |
|
|
D.The X-ray diffraction patterns of this product (measurement range: 3°~ 40 )have diffraction peaks at 2 theta as follows:6.2°±0.2°、 8.2°±0.2°、10.4°±0.2°、12.7°±0.2°and 20.8°±0.2°, |
Complies |
|
|
Specific Rotation |
+34°~+38° |
+37° |
|
Melting Range |
123℃~127℃ |
123℃~126℃ |
|
Water |
≤0.5% |
0.15% |
|
Heavy metal |
≤20ppm |
Complies |
|
Related substances I |
DiSFBMA-SFB≤0.15% |
0.05% |
|
SFBA-1≤0.15% |
Not Detected |
|
|
phenol≤0.15% |
Not Detected |
|
|
Impurity A of SFB≤0.15% |
Not Detected |
|
|
Impurity B of SFB≤0.15% |
Not Detected |
|
|
Impurity C of SFB≤0.15% |
Not Detected |
|
|
Impurity D of SFB≤0.15% |
Not Detected |
|
|
Chloro-SFB≤0.15% |
Not Detected |
|
|
SFBD3≤0.15% |
Not Detected |
|
|
2-hydroxymethyl SFB≤0.15% |
Not Detected |
|
|
Any unknown impurity ≤0.10% |
0.02% |
|
|
Total impurities ≤0.5% |
0.09% |
|
|
Related substances ⅡI |
SFBMA≤0.15% |
Not Detected |
|
Enantiomer |
SFBE≤0.15% |
0.03% |
|
Pentafluorophenol |
≤0.10% |
0.01% |
|
Genotoxic Impurities |
Sum of 1,4-dichlorobutane and 4-chloro-1-butanol≤3.75ppm |
Not Detected |
|
Residual solvents I |
Methanol≤3000ppm |
Not Detected |
|
Residual solvents I |
Ethanol≤5000ppm |
Not Detected |
|
Isopropyl alcohol≤5000ppm |
Not Detected |
|
|
Dichloromethane≤600ppm |
Not Detected |
|
|
Methyl tert-butyl ether≤5000ppm |
Not Detected |
|
|
N-Hexane≤290ppm |
Not Detected |
|
|
Isopropyl ether≤5000ppm |
Not Detected |
|
|
Ethyl acetate≤5000ppm |
Not Detected |
|
|
Tetrahydrofuran≤720ppm |
Not Detected |
|
|
Toluene≤890ppm |
Not Detected |
|
|
Chlorobenzene≤360ppm |
Not Detected |
|
|
N-Methylpyrrolidone≤530ppm |
Not Detected |
|
|
Residual solyents Ⅱ |
Benzene≤2ppm |
Not Detected |
|
Assay |
98.5%～101.0%(Calculated on the anhydrous basis) |
100.0% |
|
Tests |
Specifications |
Results |
|
Appearance |
White or off-white crystalline powder |
White crystalline powder |
|
Identification |
A.Retention Time: Similar to Reference Substance |
Complies |
|
B.The 30 μg/ml methanol solution of this product has the maximum absorption at the wavelength of 262 nm. |
Complies |
|
|
C.IR: Similar to Reference Substance |
Complies |
|
|
D.The X-ray diffraction patterns of this product (measurement range: 30～ 40°)have diffraction peaks at 2 theta as follows: 6.2°±0.2°、 8.20±0.2°、10.4°±0.2°、12.7°±0.2°and 20.8°±0.2°. |
Complies |
|
|
Specific Rotation |
+34°~+38° |
+37° |
|
Melting Range |
123℃~127℃ |
123℃~126℃ |
|
Water |
≤0.5% |
0.16% |
|
Heavy metal |
≤20ppm |
Complies |
|
Related substances I |
DiSFBMA-SFB≤0.15% |
0.05% |
|
SFBA-1≤0.15% |
Not Detected |
|
|
phenol≤0.15% |
Not Detected |
|
|
Impurity A of SFB≤0.15% |
Not Detected |
|
|
Impurity B of SFB≤0.15% |
Not Detected |
|
|
Impurity C of SFB≤0.15% |
Not Detected |
|
|
Impurity D of SFB≤0.15% |
Not Detected |
|
|
Chloro-SFB≤0.15% |
Not Detected |
|
|
SFBD3≤0.15% |
Not Detected |
|
|
2-hydroxymethyl SFB≤0.15% |
Not Detected |
|
|
Any unknown impurity ≤0.10% |
0.02% |
|
|
Total impurities ≤0.5% |
0.09% |
|
|
Related substances Ⅱ |
SFBMA≤0.15% |
Not Detected |
|
Enantiomer |
SFBE≤0.15% |
0.03% |
|
Pentafluorophenol |
≤0.10% |
0.02% |
|
Genotoxic Impurities |
Sum of 1,4-dichlorobutane and 4-chloro-1-butanol≤3.75ppm |
Not Detected |
|
Residual solvents I |
Methanol≤3000ppm |
Not Detected |
|
Residual solvents I |
Ethanol≤5000ppm |
Not Detected |
|
Isopropyl alcohol≤5000ppm |
Not Detected |
|
|
Dichloromethane≤600ppm |
Not Detected |
|
|
Methyl tert-butyl ether≤5000ppm |
Not Detected |
|
|
N-Hexane≤290ppm |
Not Detected |
|
|
Isopropyl ether≤5000ppm |
Not Detected |
|
|
Ethyl acetate≤5000ppm |
Not Detected |
|
|
Tetrahydrofuran≤720ppm |
Not Detected |
|
|
Toluene≤890ppm |
Not Detected |
|
|
Chlorobenzene≤360ppm |
Not Detected |
|
|
N-Methylpyrrolidone≤530ppm |
Not Detected |
|
|
"Residual solvents Ⅱ |
Benzene≤2ppm |
Not Detected |
|
Assay |
98.5%～101.0%(Calculated on the anhydrous basis) |
99.3% |