| Size | Price | Stock | Qty |
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| 1mg |
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| 5mg | |||
| Other Sizes |
| Targets |
HCV NS5B polymerase (the target of the parent drug). Sofosbuvir impurity E is an impurity standard, not a pharmacological agent. Its chemical structure is similar to Sofosbuvir, which is a nucleotide analog that acts as an inhibitor of the hepatitis C virus NS5B polymerase. As a stereoisomer, impurity E has a different 3D orientation, which drastically reduces its ability to bind to the viral polymerase.
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| ln Vitro |
No significant in vitro activity against HCV. Sofosbuvir impurity E is described as the "less active impurity" of Sofosbuvir. Its purpose is purely analytical; it is not used for biological assays. Compared to the parent drug, which has potent anti-HCV activity with an EC50 of ~50 nM in the HCV replicon assay, this impurity is expected to have minimal or no antiviral effect.
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| ln Vivo |
No therapeutic in vivo activity. Sofosbuvir impurity E is not used for in vivo efficacy studies. It can be used in pharmacokinetic studies as an analytical standard to detect and measure its concentration in plasma or tissue samples following administration of the parent drug, Sofosbuvir. This helps evaluate whether the impurity accumulates in the body.
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| Enzyme Assay |
Analytical HPLC method development is the standard protocol. A validated reverse-phase HPLC method with UV detection is used to separate Sofosbuvir from its impurities. A reference standard of Sofosbuvir impurity E is prepared in a suitable solvent (e.g., methanol or acetonitrile). A known concentration is injected, and the relative retention time (RRT) is determined to identify the impurity peak in complex sample mixtures.
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| Cell Assay |
Cell-based assays are not applicable for this impurity. It is not a tool for biological research. Its use is strictly as a reference material for chemical analysis. No cell culture or biological protocols exist for this compound, as it is not intended to study a biological process.
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| Animal Protocol |
Sofosbuvir impurity E is not dosed in vivo for efficacy. Its primary use in animal research is as an analytical standard for developing and validating bioanalytical methods (LC-MS/MS) to quantify the impurity in plasma samples from toxicology studies. This ensures that any potential accumulation of the impurity is accurately measured during preclinical safety evaluation.
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| ADME/Pharmacokinetics |
As an analytical standard, no specific PK data is available for Sofosbuvir impurity E. Its chemical properties are likely similar but not identical to Sofosbuvir (MW 529.45). It is a polar nucleotide analog and is expected to have low oral bioavailability. The parent drug is rapidly absorbed (Tmax ~1h) and has a short half-life (~0.5h). This impurity likely has a different metabolic rate.
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| Toxicity/Toxicokinetics |
Sofosbuvir impurity E is for research and analytical purpose only and is not for human use. It is a synthetic impurity, and toxicological data specific to this compound is not available. However, as a "less active" impurity, it is presumed to have a favorable safety profile at low levels. Its regulation is part of the overall impurity control strategy for the final drug product. Handle with standard laboratory precautions.
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| Additional Infomation |
Sofosbuvir impurity E is a chemical reference standard and not an active pharmaceutical ingredient. It has a molecular formula of C22H2₉FN3O₉P and a molecular weight of 529.45. It is an important tool for ensuring the safety and quality of Sofosbuvir drug products. The compound should be stored desiccated at -20degC to maintain stability.
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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.
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