Aquigen Bio Introduces Complete Range of Selexipag Impurity Standards to Support Global Pharmaceutical Research and Regulatory Compliance

Pune, India - 02/07/2025 - Aquigen Bio, a leading supplier of high-purity pharmaceutical reference standards, proudly announces the launch of its complete Selexipag impurity standards portfolio. This new suite includes stable isotope-labeled compounds such as Selexipag D6, Selexipag D7, and Selexipag D10, along with specialized degradation and structural impurities including the Selexipag Glycine Adduct and Selexipag Hydroxy Impurity.

These impurity standards are essential tools for drug developers, CROs, CDMOs, and analytical research labs working on Selexipag-based formulations or conducting impurity profiling in line with global regulatory requirements.

Explore the full range here: https://aquigenbio.com/products/impurity-standards/selexipag/

Selexipag: A Revolution in PAH Treatment
Selexipag is a groundbreaking oral medication approved for the treatment of Pulmonary Arterial Hypertension (PAH)-a life-threatening disorder characterized by high blood pressure in the arteries of the lungs. As a selective prostacyclin receptor (IP receptor) agonist, Selexipag mimics the effects of natural prostacyclin to induce vasodilation, reduce arterial remodeling, and improve long-term cardiovascular outcomes.

Unlike traditional prostanoids, Selexipag is a non-prostanoid molecule with enhanced stability and bioavailability. Its prodrug form is converted in vivo to the active metabolite ACT-333679, providing prolonged therapeutic activity. Given the complexity of Selexipag's metabolism and degradation behavior, pharmaceutical manufacturers are required to closely monitor and quantify related impurities to ensure patient safety and compliance with ICH Q3A/B guidelines.

This is where Aquigen Bio's specialized Selexipag impurity standards become invaluable.

Why Impurity Standards Matter in Selexipag Analysis
Impurity standards are essential for characterizing and quantifying drug-related substances during the various stages of pharmaceutical development-including formulation, stability studies, analytical method validation, and regulatory submissions (e.g., ANDA, DMF, NDA).

The presence of impurities-whether due to degradation, process residuals, or isomeric transformations-must be properly identified, controlled, and justified. Analytical labs require certified reference standards to:
Ensure method accuracy and reproducibility
Calibrate instruments and validate analytical methods
Monitor batch-to-batch consistency
Support regulatory submissions with complete impurity profiles

Aquigen Bio addresses this critical need by offering certified Selexipag impurity standards designed to align with ICH, FDA, and EMA guidelines.
Meet the Selexipag Impurity Standard Lineup from Aquigen Bio
Aquigen Bio's product line includes both stable isotope-labeled analogs for quantification and structural impurities for degradation pathway analysis.

1. Selexipag D6
https://aquigenbio.com/product/selexipag-d6/
Selexipag D6 is a deuterium-labeled analog where six hydrogen atoms are replaced with deuterium (2H). This internal standard is crucial in LC-MS/MS bioanalytical methods.
Key Benefits:
Provides consistent peak separation from the parent compound
Used to correct matrix effects and analyte recovery
Ideal for pharmacokinetic studies, toxicology, and bioequivalence trials

Selexipag D6 enables laboratories to achieve precise quantification of Selexipag in plasma, serum, or tissue samples, ensuring accurate dose-response profiles.

2. Selexipag D7
https://aquigenbio.com/product/selexipag-d7/
Selexipag D7 features seven deuterium atoms and offers improved mass resolution compared to D6. It is tailored for applications requiring high sensitivity and low detection limits.
Ideal For:
Advanced mass spectrometry methods
Metabolic stability profiling
Clinical pharmacology and toxicokinetics

Its superior performance in complex matrices makes it a preferred internal standard in preclinical and clinical workflows.

3. Selexipag D10
Selexipag D10, with ten deuterium substitutions, offers the highest level of isotopic distinction from the non-labeled parent drug. This makes it ideal for:
Ultra-sensitive LC-MS/MS applications
Dual-analyte monitoring (e.g., parent + metabolite)
Multi-compound bioanalytical validations

The enhanced signal stability of Selexipag D10 allows for greater precision, especially in long-duration analytical runs or regulatory method validations.

4. Selexipag Glycine Adduct
This glycine conjugate impurity forms through the metabolic reaction of Selexipag or its active metabolite with amino acids such as glycine.
Applications Include:
Metabolite identification and profiling
Understanding biotransformation pathways
Support in metabolomics or mass balance studies

Presence of such conjugated impurities in biological systems necessitates the availability of a structurally authenticated reference standard for accurate tracking.

5. Selexipag Hydroxy Impurity
https://aquigenbio.com/product/selexipag-hydroxy-impurity/
Oxidative degradation of Selexipag under stressed or long-term storage conditions may lead to the formation of a hydroxy impurity.
Common Use Cases:
ICH stability testing
Shelf-life estimation
Forced degradation studies

Monitoring oxidative impurities like Selexipag Hydroxy Impurity is essential to meet global pharmacopoeial standards and mitigate risks associated with degradation products.
Designed for Regulatory and Analytical Excellence

All Selexipag-related standards from Aquigen Bio are:
>98% pure (where applicable)
Supplied with COA, NMR, LC-MS, and HPLC purity data
Packaged for long-term stability and shipping worldwide
Compliant with GLP/GMP environments

These impurity standards are tailored to meet the evolving needs of drug manufacturers, academic researchers, contract research organizations (CROs), and quality assurance teams.

Contact:
Aquigen Bio Sciences
281/1, Plot No 41,
Hinjawadi - Pirangut Rd,
Kasar Amboli, Pirangut,
Pune, Maharashtra 412108
Phone: +91 7030123794
Email: bd@aquigenbio.com
Visit: www.aquigenbio.com

About Aquigen Bio
Aquigen Bio is a trusted manufacturer and global supplier of pharmaceutical impurities, isotope-labeled compounds, metabolites, and reference standards. Backed by a team of experienced scientists and a commitment to quality, Aquigen supports pharmaceutical companies, CROs, and academic institutions in over 60 countries. With a customer-first approach and dedication to scientific excellence, Aquigen Bio continues to drive innovation in analytical chemistry and regulatory science.

This release was published on openPR.