N-Propionyl Mesalazine-D3 | CAS 1330265-97-8

N-Propionyl Mesalazine-D3 | CAS 1330265-97-8

N-Propionyl Mesalazine-D3 (CAS No. 1330265-97-8) is a stable isotope-labelled reference standard widely used in pharmaceutical research, analytical method development, and bioanalytical applications involving mesalazine (5-aminosalicylic acid, 5-ASA). This deuterium-labelled analogue contains three deuterium atoms incorporated into the aromatic ring, providing a well-defined mass shift that enables accurate identification and quantification by LC-MS/MS, LC-HRMS, and other mass spectrometry-based analytical techniques. Stable isotope-labelled standards such as N-Propionyl Mesalazine-D3 are considered the gold standard for quantitative bioanalysis because they closely mimic the physicochemical behavior of the native compound while remaining distinguishable by their isotopic mass.

N-Propionyl Mesalazine-D3 is commonly employed as an internal standard during the analysis of mesalazine-related compounds, impurities, metabolites, and degradation products. The isotopic labeling minimizes analytical variability caused by sample preparation, extraction efficiency, chromatographic retention, ionization suppression, and instrument fluctuations. This results in improved precision, reproducibility, and accuracy, particularly in regulated pharmaceutical environments where validated analytical methods are required.

Product Information

• Product Name: N-Propionyl Mesalazine-D3
• CAS Number: 1330265-97-8
• Molecular Formula: C10H8D3NO4
• Molecular Weight: 212.22 g/mol
• Chemical Classification: Stable Isotope Labelled Reference Standard
• Label Type: Deuterium (D3)

Applications of N-Propionyl Mesalazine-D3:

N-Propionyl Mesalazine-D3 is extensively utilized across pharmaceutical development and quality control laboratories. Its primary applications include:

• LC-MS/MS quantitative analysis
• LC-HRMS method development
• Bioanalytical assay validation
• Pharmacokinetic and metabolism studies
• Impurity profiling
• Stability-indicating analytical methods
• Method transfer and verification
• Quality control testing
• Pharmaceutical reference standard qualification
• Regulatory submission support for ANDA, NDA, and DMF documentation

Because isotope-labelled compounds behave almost identically to their unlabeled counterparts during sample extraction and chromatographic separation, they provide excellent correction for analytical losses and matrix effects. This significantly improves assay robustness and confidence in quantitative results.

Importance in Pharmaceutical Analysis

The pharmaceutical industry increasingly relies on isotope-labelled internal standards to satisfy stringent regulatory expectations for analytical method validation. During quantitative LC-MS/MS analysis, several factors—including ion suppression, sample matrix variability, extraction recovery, and instrument response—can introduce analytical errors. N-Propionyl Mesalazine-D3 compensates for these variations because it co-elutes with the target analyte while being differentiated by its unique isotopic mass.

This makes it particularly valuable for:

• Highly sensitive bioanalytical assays
• Trace-level impurity analysis
• Therapeutic drug monitoring research
• Pharmacokinetic investigations
• Clinical sample analysis
• Validation according to FDA and ICH bioanalytical guidelines

The use of stable isotope-labelled standards improves data quality while reducing analytical uncertainty, making them indispensable tools in modern pharmaceutical laboratories.

Method Development and Validation

N-Propionyl Mesalazine-D3 supports every stage of analytical method development. Scientists frequently incorporate the compound during optimization of chromatographic conditions, selection of mass transitions, calibration curve preparation, recovery studies, precision assessments, and robustness evaluations.

Typical validation parameters include:

• Specificity
• Linearity
• Accuracy
• Precision
• Recovery
• Matrix effect evaluation
• Carryover assessment
• Stability studies
• Limit of Detection (LOD)
• Limit of Quantification (LOQ)

The isotope-labelled internal standard enables reliable correction for sample preparation losses and instrument variability, leading to more reproducible analytical methods suitable for regulated pharmaceutical environments.

Applications in Bioanalytical Studies

Bioanalytical laboratories frequently employ N-Propionyl Mesalazine-D3 during the quantification of mesalazine-related analytes in biological matrices such as plasma, serum, urine, and tissue homogenates. The compound serves as an ideal internal standard for pharmacokinetic and toxicokinetic studies because it undergoes identical extraction and chromatographic behavior while remaining distinguishable during mass spectrometric detection.

Researchers utilize this reference standard for:

• Drug metabolism investigations
• ADME studies
• Bioequivalence studies
• Clinical research
• Preclinical pharmacology
• Biomarker quantification
• Therapeutic monitoring research

The improved quantitative accuracy obtained through isotope dilution techniques contributes to reliable pharmacokinetic data and regulatory compliance.

Quality Standards

At ResolveMass Laboratories Inc., isotope-labelled reference standards are supplied with comprehensive analytical documentation to support pharmaceutical research and regulated laboratory workflows. Depending on customer requirements, available documentation may include:

• Certificate of Analysis (CoA)
• Analytical characterization
• Identity confirmation
• Mass spectrometry data
• NMR characterization (where applicable)
• Chromatographic purity information
• Storage recommendations
• Handling guidelines

These documents assist pharmaceutical manufacturers, CROs, research laboratories, and quality control facilities in maintaining traceability and supporting analytical method validation.

Why Choose ResolveMass Laboratories Inc.?

ResolveMass Laboratories Inc. provides high-quality pharmaceutical reference standards, stable isotope-labelled compounds, analytical support materials, and custom synthesis services to pharmaceutical, biotechnology, academic, and contract research organizations worldwide. Our expertise in mass spectrometry, pharmaceutical impurity characterization, isotope-labelled standards, and analytical method development enables researchers to obtain reliable materials for challenging analytical applications.

Whether supporting LC-MS/MS assay development, impurity profiling, pharmacokinetic studies, or regulatory submissions, ResolveMass Laboratories delivers scientifically characterized reference standards that help laboratories achieve accurate, reproducible, and regulatory-compliant analytical results.

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