| Size | Price | Stock | Qty |
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| 1mg |
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| 5mg | |||
| Other Sizes |
| Targets |
HCV[1]
HCV NS5B RNA-dependent RNA polymerase (structural analog). As an impurity, Sofosbuvir impurity H is not a therapeutic agent. The parent compound, Sofosbuvir, is a nucleotide analog inhibitor that targets the HCV NS5B polymerase. Impurity H is a diastereoisomer, meaning it has a different three-dimensional configuration, which likely affects its binding affinity and biological activity. |
|---|---|
| ln Vitro |
No significant biological activity is expected. Sofosbuvir impurity H is not used for therapeutic or pharmacological studies. Its value is as a chemical marker. It may show less or no antiviral activity compared to the parent drug, which has an EC50 in the low nanomolar range against HCV. In vitro assays are not relevant for its intended use.
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| ln Vivo |
Sofosbuvir impurity H is not administered to animals for therapeutic purposes. It may be used in pharmacokinetic studies as an analytical standard to identify and measure its trace levels in animal plasma after the administration of Sofosbuvir. This helps researchers understand the in vivo formation, accumulation, or clearance of this process-related impurity.
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| Enzyme Assay |
Analytical chemistry methods, primarily HPLC, are used. A reverse-phase column (e.g., C18) is employed with a gradient mobile phase consisting of buffer and organic solvent (e.g., acetonitrile or methanol). The method is validated for specificity, linearity, and accuracy. A reference standard solution of Sofosbuvir impurity H is injected to determine its retention time and response factor relative to the main drug.
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| Cell Assay |
Cell-based assays are not performed. Sofosbuvir impurity H is not intended to be used in cell culture. It is strictly an analytical chemistry standard. Its use is confined to the laboratory bench for quality control testing. No cellular or biological protocols are required for its application.
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| Animal Protocol |
Animal studies are not typically performed with the isolated impurity. In the context of drug development, it may be used to spike biological samples (e.g., rat or dog plasma) to create calibration standards. These standards are then used to measure the exposure of the impurity in a toxicokinetic study where the parent drug, Sofosbuvir, is administered to animals.
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| ADME/Pharmacokinetics |
Sofosbuvir impurity H is a research-grade analytical standard, not intended for PK studies as a therapeutic agent. The parent compound Sofosbuvir is highly water-soluble, has a plasma half-life of about 30-60 minutes, and is rapidly converted to an active metabolite. Impurity H, as a diastereoisomer, may have distinct solubility and metabolic stability.
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| Toxicity/Toxicokinetics |
Sofosbuvir impurity H is intended for research and pharmaceutical quality control use only. It is not for human consumption. No specific toxicological data is available for this impurity, but its presence in the drug product is strictly controlled by regulatory guidelines (e.g., ICH). It is considered a non-critical impurity at levels below 0.15%. Standard safety precautions for handling reference standards should be followed.
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| Additional Infomation |
Sofosbuvir impurity H is an analytical reference standard used in pharmaceutical development. It is not a drug and has no therapeutic or diagnostic applications. It is available as a high-purity compound for research. The molecular formula is C2₉H33FN3O10P, and it has a molecular weight of 633.56. For storage, the powder should be kept at -20degC, protected from light and moisture.
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| Molecular Formula |
C29H33FN3O10P
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|---|---|
| Molecular Weight |
633.56
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| Appearance |
White to off-white solid powder
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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 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.) |
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| Preparing Stock Solutions | 1 mg | 5 mg | 10 mg | |
| 1 mM | 1.5784 mL | 7.8919 mL | 15.7838 mL | |
| 5 mM | 0.3157 mL | 1.5784 mL | 3.1568 mL | |
| 10 mM | 0.1578 mL | 0.7892 mL | 1.5784 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.
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