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Aquigen Bio Expands Impurity Standards Portfolio with High-Purity Vibegron Impurity 1 to Support Quality Control, Regulatory Compliance, and Analytical Development in Vibegron-Based Pharmaceutical Products

05-08-2025 12:26 PM CET | Health & Medicine

Press release from: Aquigen Bio Sciences

Aquigen Bio Expands Impurity Standards Portfolio with

April 11, 2025 - Pune, India | Aquigen Bio, a trusted name in pharmaceutical reference standards, has announced the availability of Vibegron Impurity 1, offering researchers and manufacturers a high-quality impurity standard for advanced analytical development and regulatory compliance in neurotherapeutics.

To know more about Vibegron Impurity 1
https://aquigenbio.com/product/vibegron-impurity-1/

Vibegron, a β3-adrenergic receptor agonist, is a key molecule in the treatment of overactive bladder (OAB). With its growing clinical application, accurate profiling and control of impurities are vital for maintaining the safety, efficacy, and quality of Vibegron-based formulations. Aquigen Bio's Vibegron Impurity 1 is synthesized and characterized to meet stringent pharmaceutical requirements, supporting quality control labs, R&D centers, and regulatory filings across the globe.

A Comprehensive Impurity Offering for Vibegron
As part of its expanding impurity standards range, Aquigen Bio also offers:
Vibegron Impurity 2: Ideal for identifying secondary degradation products or process-related impurities during method validation and stability studies.

To know more
https://aquigenbio.com/product/vibegron-impurity-2/

Vibegron Impurity 10: Enables a comprehensive impurity profile for drug substance and formulation analysis, ensuring compliance with ICH Q3A/B guidelines.

To know more
https://aquigenbio.com/product/vibegron-impurity-10/

Vibegron D7: A deuterated internal standard for precise quantification in LC-MS assays, enhancing sensitivity and reproducibility in impurity determination.
To know more
https://aquigenbio.com/product/vibegron-d7/

Meeting Global Pharma Needs
Aquigen Bio's impurity standards are developed under strict GMP-like conditions and undergo extensive characterization, including HPLC, NMR, and Mass Spectrometry. Each product is supplied with a Certificate of Analysis (CoA) and associated spectral data to support method development, validation, and regulatory submissions.

"Impurity standards like Vibegron Impurity 1 are essential for ensuring therapeutic product safety and regulatory success. Our commitment is to provide scientists with reliable, high-purity materials to streamline drug development and quality assurance," said a company spokesperson.

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 specializes in the synthesis and supply of impurity standards, isotope-labeled compounds, and reference materials for pharmaceutical and biopharmaceutical companies worldwide. With a focus on quality, speed, and customization, Aquigen Bio supports clients from discovery through post-market surveillance.

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