Exploring Dabigatran and Its Impurities: Reliable Solutions from Aquigen Bio

FLORINOPOLIS, Brazil - June 3, 2025 - PRLog -- In the world of pharmaceutical development and analytical testing, the quality and reliability of reference standards are non-negotiable. This is particularly true when working with Dabigatran, a direct thrombin inhibitor widely used in anticoagulant therapies for conditions like atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism (PE). Ensuring the safety, efficacy, and consistency of Dabigatran-based drugs requires precise monitoring of impurities and degradation products.

Whether you're part of a quality control laboratory, a research and development team, or managing regulatory filings, having access to well-characterized, traceable impurity standards is essential. That's where Aquigen Bio comes in — providing pharmaceutical and analytical professionals with high-purity materials that support compliance and innovation.

Aquigen Bio: Setting the Standard in Dabigatran Impurities

Aquigen Bio is a globally recognized manufacturer and supplier of pharmaceutical reference materials, offering an extensive catalog of impurities and intermediates, especially for critical APIs like Dabigatran. With a deep commitment to scientific rigor and regulatory alignment, Aquigen Bio empowers clients across the pharmaceutical value chain.

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Aquigen's Dabigatran Portfolio Includes:

Dabigatran Impurity 13

Dabigatran Impurity 12

Dabigatran Etexilate Mesylate

Dabigatran Etexilate N-oxide

Dabigatran Etexilate USP Related Compound C

Dabigatran Hydrobromide

Dabigatran Hydrochloride
Dabigatran Impurity 1

Dabigatran Impurity 10
Dabigatran Impurity 11

https://aquigenbio.com/product/dabigatran-etexilate-n-oxide/

These reference materials are developed under strict quality control and come with comprehensive documentation including Certificates of Analysis (COA), NMR, HPLC, and Mass Spectra, ensuring traceability and reproducibility in every batch.

Applications and Regulatory Significance

Dabigatran impurities and intermediates are not just chemical markers — they are crucial tools for:

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Method validation and development

Stability and forced degradation studies

Impurity profiling as per ICH Q3A/B guidelines

Bioanalytical method calibration

https://aquigenbio.com/product/dabigatran-etexilate-n-oxide/

Batch release and QC testing
Regulatory bodies such as USFDA, EMA, MHRA, and CDSCO require pharmaceutical manufacturers to identify, quantify, and control impurities to ensure patient safety. Having access to validated and traceable impurity standards like those from Aquigen Bio is key to passing audits and maintaining global compliance.