Anagrelide-D2-¹³C2-¹⁵N | CAS No. 68475-42-3

Product Overview

Anagrelide-D2-¹³C2-¹⁵N is a stable isotope-labeled analogue of Anagrelide, specifically designed for use as an internal standard in LC-MS/MS, LC-HRMS, and other mass spectrometry-based quantitative analytical methods. The molecule incorporates two deuterium (D₂), two carbon-13 (¹³C₂), and one nitrogen-15 (¹⁵N) isotopes, resulting in a predictable mass shift while maintaining nearly identical chemical and chromatographic properties to the native compound.

Stable isotope-labeled standards are considered the gold standard for quantitative bioanalysis because they effectively compensate for sample preparation losses, matrix effects, ion suppression, and instrument variability. As a result, Anagrelide-D2-¹³C2-¹⁵N enables highly accurate and reproducible quantification of anagrelide in complex biological matrices such as plasma, serum, urine, and tissue samples.

Anagrelide is a phosphodiesterase III inhibitor approved for the treatment of essential thrombocythemia, a myeloproliferative disorder characterized by elevated platelet counts. Accurate measurement of anagrelide concentrations is essential during pharmacokinetic (PK), bioavailability (BA), bioequivalence (BE), metabolism, toxicokinetic, and therapeutic drug monitoring studies. The isotope-labeled analogue ensures reliable quantitative analysis by co-eluting with the analyte while being distinguishable by its higher molecular mass during mass spectrometric detection.

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Chemical Properties

*Actual molecular weight may vary slightly depending on isotopic enrichment.

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Key Features

• Stable isotope-labeled analogue of Anagrelide
• Ideal internal standard for LC-MS/MS quantification
• Excellent chromatographic co-elution with native analyte
• Corrects for extraction recovery variability
• Minimizes matrix effects and ion suppression
• Improves assay precision and accuracy
• Suitable for highly sensitive bioanalytical methods
• Compatible with regulatory bioanalysis
• High isotopic enrichment for reliable mass separation
• Manufactured under stringent quality standards

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Applications

Anagrelide-D2-¹³C2-¹⁵N is widely used in pharmaceutical research, clinical laboratories, contract research organizations (CROs), and analytical testing laboratories.

Major applications include:

• LC-MS/MS bioanalytical assays
• UHPLC-MS/MS quantitative analysis
• High-resolution LC-MS analysis
• Pharmacokinetic (PK) studies
• Bioavailability (BA) studies
• Bioequivalence (BE) studies
• Therapeutic drug monitoring (TDM)
• Drug metabolism studies
• ADME investigations
• Toxicokinetic studies
• Clinical research
• Biomarker analysis
• Pharmaceutical quality control
• Method development
• Method validation following ICH M10 and FDA Bioanalytical Method Validation Guidance

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Advantages of Stable Isotope-Labeled Internal Standards

Quantitative mass spectrometry relies on accurate normalization to compensate for unavoidable analytical variability. Stable isotope-labeled compounds behave almost identically to their unlabeled counterparts during extraction, chromatography, and ionization while remaining distinguishable by mass.

The use of Anagrelide-D2-¹³C2-¹⁵N provides several analytical benefits:

• Corrects extraction efficiency differences
• Compensates for ion suppression and enhancement
• Improves quantitative accuracy
• Reduces inter-sample variability
• Enhances method robustness
• Supports low-level quantification
• Improves inter-day and intra-day precision
• Facilitates regulatory compliance
• Increases confidence in pharmacokinetic data

These characteristics make isotope-labeled standards indispensable for regulated bioanalytical laboratories.

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Compatibility with Analytical Platforms

Anagrelide-D2-¹³C2-¹⁵N is compatible with a wide range of analytical instrumentation, including:

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

Its predictable isotopic mass shift enables selective monitoring without interfering with endogenous compounds or the native analyte.

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Pharmaceutical Research Applications

This isotope-labeled reference standard supports every stage of pharmaceutical drug development, including:

Discovery Research

Supports early-stage quantitative method development and lead optimization studies.

Preclinical Studies

Used for pharmacokinetic profiling, dose proportionality assessments, metabolism investigations, and toxicokinetic studies.

Clinical Development

Provides accurate quantification during Phase I, II, and III clinical trials, ensuring reliable pharmacokinetic data generation.

Generic Drug Development

Essential for bioequivalence studies comparing generic formulations with reference listed drugs.

Regulatory Submissions

Supports validated analytical methods used in IND, NDA, ANDA, and global regulatory submissions.

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Quality Assurance

ResolveMass Laboratories Inc. supplies high-quality stable isotope-labeled reference standards with stringent quality control to ensure analytical reliability. Each batch is characterized for:

• Chemical identity
• Chemical purity
• Isotopic enrichment
• Mass spectrometric confirmation
• Chromatographic performance
• Stability
• Batch-to-batch consistency

These quality attributes ensure dependable performance across regulated pharmaceutical and bioanalytical applications.

 

Learn more about Deuterated Chemicals through,

• Deuterated Polymers: A Cornerstone Guide to Synthesis, Applications, and Future Trends
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