| Size | Price | Stock | Qty |
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| 1mg |
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| 5mg | |||
| Other Sizes |
| Targets |
HCV NS5B RNA-dependent RNA polymerase (the binding site of the parent drug). Sofosbuvir impurity B is an analytical standard, not a pharmacological agent. The parent compound, Sofosbuvir, is a uridine nucleotide analog that acts as a potent inhibitor of the HCV NS5B polymerase, causing chain termination during viral RNA replication. As a diastereoisomer, Impurity B has a distinct spatial configuration, altering its interaction with the active site.
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| ln Vitro |
No significant in vitro biological activity. Sofosbuvir impurity B is described as the "less active impurity" and is not intended for pharmacological or biological studies. The parent drug, Sofosbuvir, has EC50 values ranging from 50-150 nM against HCV. In contrast, impurity B is expected to have minimal or no antiviral effect, which is why it is classified as an impurity rather than a drug.
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| ln Vivo |
No in vivo activity. Sofosbuvir impurity B is not used for in vivo efficacy testing. Its use in animal research is limited to acting as a quantitative standard. It can be used to develop and validate bioanalytical methods for measuring trace levels of this impurity in plasma and tissue samples from animals dosed with Sofosbuvir.
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| Enzyme Assay |
Sofosbuvir impurity B is characterized and quantified using a non-cell-based HPLC method. A reverse-phase column (e.g., Zorbax SB-C18) is used with a gradient elution system. Mobile phase A is an aqueous buffer (e.g., ammonium acetate, pH 5.5), and mobile phase B is acetonitrile. The flow rate is 1.0 mL/min, and detection is at 260 nm. The impurity is identified by its relative retention time (RRT).
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| Cell Assay |
Cell-based assays are not applicable for this compound. It is strictly an analytical chemistry reference material. It is not used to treat cells or to investigate a molecular pathway. No biological protocols are required for its use.
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| Animal Protocol |
Animal studies are not performed with isolated Sofosbuvir impurity B. It can be used in a research setting as a control or as a spiking standard for assay validation. For example, blank plasma is spiked with known concentrations of this impurity to create a standard curve for an LC-MS/MS bioanalytical method, ensuring the method can accurately quantify the impurity in a later toxicokinetic study.
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| ADME/Pharmacokinetics |
PK data is not applicable for this impurity. It is an analytical standard. The parent drug, Sofosbuvir (MW 529.45), is rapidly absorbed and metabolized. Impurity B, being a diastereoisomer, may have different physico-chemical properties, such as water solubility and stability. It is soluble in DMSO and ethanol, which is standard for reference standard preparation.
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| Toxicity/Toxicokinetics |
No specific toxicology data is available for Sofosbuvir impurity B. It is intended for research and analytical use only, not for human use. As a "less active" impurity, it is presumed to be less potent and potentially less toxic than the parent drug. Its levels are controlled to below 0.15% in the drug product as a non-specified impurity. Standard laboratory safety guidelines for handling chemicals should be followed.
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| Additional Infomation |
Sofosbuvir impurity B is a non-therapeutic research compound. It serves as a reference standard for the pharmaceutical industry. It is critical for the quality control of Sofosbuvir, a blockbuster antiviral drug. The molecular formula is C22H2₉FN3O₉P, and the molecular weight is 529.45. It is for research use only and should be stored at -20degC in a dry, well-ventilated place.
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| Molecular Formula |
C22H29FN3O9P
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|---|---|
| Appearance |
Typically exists as solid at room temperature
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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.) |
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.
Products are for research use only; We do not sell to patients
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