| Size | Price | Stock | Qty |
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| 1mg |
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| 5mg |
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| Other Sizes |
| Targets |
The primary biological target is the HCV NS5B RNA-dependent RNA polymerase, the enzyme responsible for viral RNA replication. Sofosbuvir is a prodrug that is metabolized intracellularly to its active triphosphate form (GS-461203), which acts as a chain terminator by incorporating into nascent viral RNA and blocking further elongation. Sofosbuvir impurity J, as a diastereoisomer, may have altered metabolic activation or binding affinity, but its primary role is as an analytical impurity rather than a therapeutic agent.
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| ln Vitro |
In vitro, Sofosbuvir impurity J is used as an analytical standard rather than for biological activity testing. As a diastereoisomer of sofosbuvir, it may exhibit reduced or altered antiviral activity compared to the active diastereomer. However, detailed in vitro potency data (e.g., EC50 against HCV replicons) are not typically reported for this impurity. Its primary utility is in analytical method validation for quantifying sofosbuvir and its impurities in pharmaceutical formulations.
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| ln Vivo |
In vivo activity data for Sofosbuvir impurity J are not available, as it is not administered as a therapeutic agent. Its presence in sofosbuvir drug products is controlled as an impurity. The parent drug sofosbuvir demonstrates potent in vivo antiviral activity, achieving sustained virologic response rates of >90% in HCV-infected patients when used in combination with other direct-acting antivirals. The impurity is monitored to ensure it remains below regulatory thresholds.
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| Enzyme Assay |
For non-cellular analytical assays, Sofosbuvir impurity J is analyzed by high-performance liquid chromatography (HPLC) using a chiral or achiral stationary phase. It is detected by UV absorbance (typically at 260 nm) or mass spectrometry. The impurity is resolved from sofosbuvir and other related substances, and its relative retention time and response factor are determined for quantification.
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| Cell Assay |
For cell-based assays, Sofosbuvir impurity J could be tested for antiviral activity against HCV in replicon systems (e.g., Huh-7 cells harboring HCV replicons). Cells are treated with the impurity at various concentrations, and HCV RNA replication is measured by quantitative RT-PCR or luciferase reporter activity. Cytotoxicity is assessed by MTT assay. However, such studies are rarely reported for impurities.
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| Animal Protocol |
For in vivo experiments, no established protocols exist for Sofosbuvir impurity J. As an impurity, it is not administered to animals. Pharmacokinetic studies of sofosbuvir in animals and humans measure the parent drug and its active metabolite, but not impurity J. Analytical methods for quantifying impurity J in plasma or tissues are not routinely developed because it is not a therapeutic entity.
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| Molecular Formula |
C22H30FN4O8P
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|---|---|
| Molecular Weight |
528.46777009964
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| Exact Mass |
528.178
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| CAS # |
1334513-10-8
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| PubChem CID |
56649065
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| Appearance |
Light yellow to yellow solid powder
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| LogP |
0.7
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| Hydrogen Bond Donor Count |
3
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| Hydrogen Bond Acceptor Count |
10
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| Rotatable Bond Count |
11
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| Heavy Atom Count |
36
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| Complexity |
928
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| Defined Atom Stereocenter Count |
6
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| SMILES |
C[C@@H](C(=O)OC(C)C)N[P@](=O)(OC[C@@H]1[C@H]([C@@]([C@@H](O1)N2C=CC(=NC2=O)N)(C)F)O)OC3=CC=CC=C3
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| InChi Key |
JMTNHBQFZOWQKE-IQWMDFIBSA-N
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| InChi Code |
InChI=1S/C22H30FN4O8P/c1-13(2)33-19(29)14(3)26-36(31,35-15-8-6-5-7-9-15)32-12-16-18(28)22(4,23)20(34-16)27-11-10-17(24)25-21(27)30/h5-11,13-14,16,18,20,28H,12H2,1-4H3,(H,26,31)(H2,24,25,30)/t14-,16+,18+,20+,22+,36-/m0/s1
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| Chemical Name |
propan-2-yl (2S)-2-[[[(2R,3R,4R,5R)-5-(4-amino-2-oxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy-phenoxyphosphoryl]amino]propanoate
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| HS Tariff Code |
2934.99.9001
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| Storage |
Powder -20°C 3 years 4°C 2 years In solvent -80°C 6 months -20°C 1 month |
| Shipping Condition |
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
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| Solubility (In Vitro) |
May dissolve in DMSO (in most cases), if not, try other solvents such as H2O, Ethanol, or DMF with a minute amount of products to avoid loss of samples
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| Solubility (In Vivo) |
Note: Listed below are some common formulations that may be used to formulate products with low water solubility (e.g. < 1 mg/mL), you may test these formulations using a minute amount of products to avoid loss of samples.
Injection Formulations
Injection Formulation 1: DMSO : Tween 80: Saline = 10 : 5 : 85 (i.e. 100 μL DMSO stock solution → 50 μL Tween 80 → 850 μL Saline)(e.g. IP/IV/IM/SC) *Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH ₂ O to obtain a clear solution. Injection Formulation 2: DMSO : PEG300 :Tween 80 : Saline = 10 : 40 : 5 : 45 (i.e. 100 μL DMSO → 400 μLPEG300 → 50 μL Tween 80 → 450 μL Saline) Injection Formulation 3: DMSO : Corn oil = 10 : 90 (i.e. 100 μL DMSO → 900 μL Corn oil) Example: Take the Injection Formulation 3 (DMSO : Corn oil = 10 : 90) as an example, if 1 mL of 2.5 mg/mL working solution is to be prepared, you can take 100 μL 25 mg/mL DMSO stock solution and add to 900 μL corn oil, mix well to obtain a clear or suspension solution (2.5 mg/mL, ready for use in animals). View More
Injection Formulation 4: DMSO : 20% SBE-β-CD in saline = 10 : 90 [i.e. 100 μL DMSO → 900 μL (20% SBE-β-CD in saline)] Oral Formulations
Oral Formulation 1: Suspend in 0.5% CMC Na (carboxymethylcellulose sodium) Oral Formulation 2: Suspend in 0.5% Carboxymethyl cellulose Example: Take the Oral Formulation 1 (Suspend in 0.5% CMC Na) as an example, if 100 mL of 2.5 mg/mL working solution is to be prepared, you can first prepare 0.5% CMC Na solution by measuring 0.5 g CMC Na and dissolve it in 100 mL ddH2O to obtain a clear solution; then add 250 mg of the product to 100 mL 0.5% CMC Na solution, to make the suspension solution (2.5 mg/mL, ready for use in animals). View More
Oral Formulation 3: Dissolved in PEG400  (Please use freshly prepared in vivo formulations for optimal results.) |
| Preparing Stock Solutions | 1 mg | 5 mg | 10 mg | |
| 1 mM | 1.8923 mL | 9.4613 mL | 18.9226 mL | |
| 5 mM | 0.3785 mL | 1.8923 mL | 3.7845 mL | |
| 10 mM | 0.1892 mL | 0.9461 mL | 1.8923 mL |
*Note: Please select an appropriate solvent for the preparation of stock solution based on your experiment needs. For most products, DMSO can be used for preparing stock solutions (e.g. 5 mM, 10 mM, or 20 mM concentration); some products with high aqueous solubility may be dissolved in water directly. Solubility information is available at the above Solubility Data section. Once the stock solution is prepared, aliquot it to routine usage volumes and store at -20°C or -80°C. Avoid repeated freeze and thaw cycles.
Calculation results
Working concentration: mg/mL;
Method for preparing DMSO stock solution: mg drug pre-dissolved in μL DMSO (stock solution concentration mg/mL). Please contact us first if the concentration exceeds the DMSO solubility of the batch of drug.
Method for preparing in vivo formulation::Take μL DMSO stock solution, next add μL PEG300, mix and clarify, next addμL Tween 80, mix and clarify, next add μL ddH2O,mix and clarify.
(1) Please be sure that the solution is clear before the addition of next solvent. Dissolution methods like vortex, ultrasound or warming and heat may be used to aid dissolving.
(2) Be sure to add the solvent(s) in order.