| Size | Price | Stock | Qty |
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| 1mg |
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| 5mg | |||
| Other Sizes |
| Targets |
HCV NS5B RNA-dependent RNA polymerase (the target of the parent drug). Sofosbuvir impurity D is not a pharmacological agent. Its parent compound, Sofosbuvir, is a direct-acting antiviral that inhibits the HCV NS5B polymerase, terminating viral RNA replication. As a diastereoisomer, impurity D has a different spatial arrangement of atoms, which results in reduced binding affinity for the viral polymerase.
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| ln Vitro |
No significant in vitro antiviral activity. Sofosbuvir impurity D is the "less active impurity" and is therefore not used for antiviral studies. Its purpose is exclusively for analytical chemistry. In comparison, the active parent drug Sofosbuvir demonstrates potent anti-hepatitis C virus activity with EC50 values in the low nanomolar range in the HCV replicon assay.
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| ln Vivo |
No therapeutic in vivo activity. Sofosbuvir impurity D is not for in vivo use. Its application is limited to analytical testing. It can be used in preclinical research to spike biological matrices (e.g., plasma) to develop and validate a sensitive LC-MS/MS method for detecting and quantifying the impurity in animal samples during drug development.
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| Enzyme Assay |
A standard reverse-phase HPLC method is used to separate and quantify this impurity. A C18 column is typically employed with a mobile phase gradient of ammonium acetate buffer and acetonitrile/methanol. The method is validated for specificity, system suitability, and linearity. Sofosbuvir impurity D is injected as a reference standard to identify its peak in the drug product's chromatogram.
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| Cell Assay |
Cell-based assays are not applicable for this reference standard. It is not intended to be used to treat cells or to study a biological mechanism. Its use is confined to the quality control laboratory. No cellular protocols are relevant for the application of Sofosbuvir impurity D.
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| Animal Protocol |
Animal studies are not typically performed with the isolated impurity. However, it can be used in method validation for bioanalysis. For example, blank rat or dog plasma is spiked with known amounts of Sofosbuvir impurity D to create calibration curves and quality control samples. These are used to validate an LC-MS/MS method for measuring the impurity in pharmacokinetic studies.
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| ADME/Pharmacokinetics |
Not applicable. Sofosbuvir impurity D is not studied for its own PK properties. It is used to standardize the detection of trace impurities. The parent drug has a molecular weight of 529.45 and a half-life of 0.5-1 h in humans. Impurity D is an analytical reference standard used to accurately quantify this specific impurity for regulatory compliance.
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| Toxicity/Toxicokinetics |
Toxicological data for Sofosbuvir impurity D is not available, as it is not a therapeutic entity. It is considered a process-related impurity, and its allowable levels in the final drug product are determined by toxicological limits (e.g., 0.15% for unspecified impurities). As a "less active" analog, it is considered to have a lower risk of toxicity than the active drug. Handle with standard chemical safety protocols.
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| Additional Infomation |
Sofosbuvir impurity D is a reference standard for pharmaceutical quality control and has no clinical use. It helps manufacturers and researchers monitor the synthesis and stability of Sofosbuvir. The molecular formula is C22H2₉FN3O₉P, with a molecular weight of 529.45. The compound is for research use only and should be stored at -20degC, sealed and protected from moisture.
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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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