| Size | Price | Stock | Qty |
|---|---|---|---|
| 1mg |
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| 5mg | |||
| Other Sizes |
| Targets |
HCV[1]
HCV NS5B RNA-dependent RNA polymerase. As a diastereoisomer of Sofosbuvir, the parent compound is a nucleotide analog inhibitor that targets the HCV NS5B polymerase. Sofosbuvir impurity L is not intended for pharmacological use but serves as a marker. It is structurally similar to the parent drug and may have different biological activity or toxicity. |
|---|---|
| ln Vitro |
No significant antiviral activity. As a non-drug substance, Sofosbuvir impurity L is used solely as an analytical reference standard. In vitro studies would not investigate its antiviral potency, but rather its presence as a byproduct. Its utility lies in its ability to be separated and detected by HPLC. It is expected to be less active than the parent compound, which has an EC50 of 50-150 nM against HCV.
|
| ln Vivo |
Sofosbuvir impurity L is not administered to animals for therapeutic purposes. It is used in pharmacokinetic and toxicokinetic studies as a marker to track the presence of this impurity in the blood or tissues after administration of the parent drug, Sofosbuvir. This helps in understanding the metabolic profile and potential toxicity of the drug substance.
|
| Enzyme Assay |
Analytical HPLC is the primary method. A reverse-phase column (e.g., C18) is used with a mobile phase of ammonium formate buffer and acetonitrile. The method is validated for specificity, linearity, accuracy, and precision. A solution of Sofosbuvir impurity L is injected at a known concentration, and its retention time is compared to the parent Sofosbuvir peak. Non-cell-based activity assays are not applicable.
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| Cell Assay |
Cell-based assays are not applicable. This compound is not used to treat cells or study biological mechanisms. Its use is confined to analytical chemistry. Cell culture models might be used to study the metabolic conversion of Sofosbuvir into impurity L, but typically this impurity is a synthetic byproduct, not a metabolite.
|
| Animal Protocol |
Animal studies are not typically performed with the isolated impurity alone. In an animal PK study, Sofosbuvir impurity L can be used as a reference standard to identify and quantify its presence in plasma or tissue samples collected from animals dosed with Sofosbuvir. This allows for the generation of a pharmacokinetic profile of the impurity.
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| ADME/Pharmacokinetics |
Sofosbuvir impurity L is a research-grade analytical standard. The parent drug, Sofosbuvir, has a bioavailability of over 90% in humans, is rapidly absorbed (Tmax ~1 h), and has a half-life of about 0.5 h. Its active metabolite has a longer half-life (~27 h). The impurity, being a diastereoisomer, likely has altered PK properties, including different rates of absorption or metabolism.
|
| Toxicity/Toxicokinetics |
Sofosbuvir impurity L is used for research purposes only, not for human or veterinary use. Toxicological data for this specific impurity is not extensively published. However, it is classified as a process impurity, meaning its levels are strictly controlled in the final drug product. Its toxicity profile may differ from Sofosbosvir, highlighting the importance of its identification and quantification during quality control.
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| Additional Infomation |
Sofosbuvir impurity L is an analytical reference standard. It is not an active pharmaceutical ingredient (API) and has no therapeutic application. Its sole purpose is for quality control and pharmaceutical analysis to ensure the purity of Sofosbuvir drug substance. It has a molecular formula of C22H2₉FN3O10P and a molecular weight of 545.45. Store at -20degC for long-term stability.
|
| Molecular Formula |
C22H29FN3O10P
|
|---|---|
| Appearance |
Typically exists as solid at room temperature
|
| HS Tariff Code |
2934.99.9001
|
| 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)
|
| Solubility (In Vitro) |
THF :~10 mg/mL (~18.33 mM)
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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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