Ledipasvir-d6 | CAS 2050041-12-6

Ledipasvir-d6 | CAS 2050041-12-6

Ledipasvir-d6 is a stable isotope-labeled analog of Ledipasvir, a potent NS5A inhibitor widely used in antiviral drug development and pharmaceutical analysis. In Ledipasvir-d6, six hydrogen atoms are replaced with deuterium (²H), creating a compound that possesses nearly identical chemical and physical properties to the parent molecule while exhibiting a distinct mass spectral signature. This characteristic makes Ledipasvir-d6 an ideal internal standard for quantitative LC-MS/MS and LC-HRMS assays used in pharmaceutical, bioanalytical, pharmacokinetic, and impurity testing applications.

ResolveMass Laboratories provides high-quality isotope-labeled reference standards such as Ledipasvir-d6 to support drug development programs, bioequivalence studies, analytical method validation, therapeutic drug monitoring research, and regulatory submissions.

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Product Information

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Overview of Ledipasvir

Ledipasvir is a direct-acting antiviral (DAA) that targets the hepatitis C virus (HCV) non-structural protein 5A (NS5A). NS5A plays a critical role in viral replication, assembly, and secretion. By inhibiting this protein, Ledipasvir effectively suppresses HCV replication and has become a key component of combination therapies for chronic hepatitis C infection. Studies have demonstrated extremely potent antiviral activity against multiple HCV genotypes, making Ledipasvir one of the most successful antiviral agents developed in recent years.

The deuterated analog, Ledipasvir-d6, maintains the same chromatographic behavior and extraction efficiency as the non-labeled drug while providing a distinguishable mass transition during mass spectrometric detection. This makes it particularly valuable for highly accurate quantitative analysis.

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Importance of Stable Isotope-Labeled Standards

Stable isotope-labeled compounds are considered the gold standard for quantitative bioanalysis because they compensate for analytical variability arising from:

• Matrix effects
• Ion suppression or enhancement
• Sample preparation losses
• Instrumental fluctuations
• Extraction variability
• Chromatographic inconsistencies

Because Ledipasvir-d6 closely mimics the behavior of native Ledipasvir throughout sample preparation and analysis, it significantly improves assay accuracy, precision, and reproducibility. Regulatory agencies such as the FDA and EMA generally recommend isotope-labeled internal standards whenever available for LC-MS/MS bioanalytical methods.

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Applications of Ledipasvir-d6 :

1. LC-MS/MS Quantification

Ledipasvir-d6 is extensively used as an internal standard for the quantification of Ledipasvir in:

• Human plasma
• Serum
• Whole blood
• Urine
• Tissue homogenates
• Cell culture samples

Its isotopic labeling allows precise correction of analytical variability, ensuring reliable quantification across complex biological matrices.

2. Bioequivalence Studies

Generic drug manufacturers conducting bioequivalence studies require highly sensitive and validated bioanalytical methods. Ledipasvir-d6 serves as an essential internal standard for determining pharmacokinetic parameters such as:

• Cmax
• Tmax
• AUC
• Half-life
• Clearance

Accurate measurement of these parameters is critical for demonstrating equivalence between generic and reference formulations.

3. Pharmacokinetic Research

Researchers studying absorption, distribution, metabolism, and excretion (ADME) profiles utilize Ledipasvir-d6 to support robust quantitative analysis in preclinical and clinical studies. The compound enables reliable measurement of trace drug concentrations throughout the pharmacokinetic profile.

4. Method Development and Validation

Analytical laboratories employ Ledipasvir-d6 during:

• Method development
• Accuracy assessments
• Precision evaluations
• Recovery studies
• Stability testing
• Matrix effect investigations

The use of a deuterated internal standard improves compliance with regulatory expectations for bioanalytical method validation.

5. Pharmaceutical Quality Control

Ledipasvir-d6 supports quality control testing during:

• API manufacturing
• Finished product analysis
• Stability studies
• Batch release testing
• Investigational drug development

Its incorporation into validated analytical methods enhances confidence in quantitative results generated during product lifecycle management.

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Advantages of Ledipasvir-d6

Superior Quantitative Accuracy

Since Ledipasvir-d6 closely resembles the parent drug chemically, it experiences nearly identical extraction recovery and chromatographic retention, improving quantitative reliability.

Reduced Matrix Effects

The isotopic label helps compensate for ionization suppression or enhancement caused by biological matrices, leading to more accurate concentration determinations.

Enhanced Regulatory Compliance

Stable isotope-labeled internal standards are widely recognized as best practice for regulated bioanalytical workflows supporting FDA, EMA, and Health Canada submissions.

Improved Reproducibility

Ledipasvir-d6 minimizes run-to-run and analyst-to-analyst variability, resulting in highly reproducible data across laboratories and studies.

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Analytical Techniques Compatible with Ledipasvir-d6

Ledipasvir-d6 is commonly utilized in conjunction with:

• LC-MS/MS
• UHPLC-MS/MS
• LC-HRMS
• Triple Quadrupole Mass Spectrometry
• QTOF-MS
• Orbitrap Mass Spectrometry

These analytical platforms provide the sensitivity and selectivity required for quantifying Ledipasvir in biological and pharmaceutical matrices at trace concentration levels.

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Why Choose ResolveMass Laboratories?

ResolveMass Laboratories specializes in stable isotope-labeled standards, pharmaceutical reference materials, and advanced mass spectrometry solutions for the pharmaceutical and biotechnology industries. Our team supports clients throughout the drug development lifecycle with:

• Isotope-labeled reference standards
• Bioanalytical method development
• LC-MS/MS assay validation
• Pharmacokinetic sample analysis
• Impurity characterization
• Regulatory submission support
• Custom synthesis services

Our scientific expertise and commitment to quality ensure reliable products that meet the demanding requirements of modern pharmaceutical research and regulatory compliance.

 

Learn more about Deuterated Chemicals through,

• Deuterated Polymers: A Cornerstone Guide to Synthesis, Applications, and Future Trends
• Availability of All the Deuterated Chemicals at ResolveMass Laboratories Inc. 
• ResolveMass Laboratories: Leading Deuterated Chemical Synthesis Company in the United States.
• Deuterated Internal Standards for LC-MS: Selection & Custom Synthesis 
• How to Choose the Right Deuterated Labelled Chemical Synthesis Company in Canada 
• How to Choose the Right Deuterium Labelled Compounds Supplier for Your Lab 
• Deuterium-Labelled Compounds — Synthesis, Applications & Ordering 
• Custom Synthesis of Deuterated Chemicals