Precision in Impurity Profiling: Aquigen Bio Introduces High-Purity Doxorubicin Dimer Impurity 3 for Enhanced Analytical Accuracy

Pune, India - July 2025 - As regulatory standards tighten across the pharmaceutical industry, the need for accurate, high-purity reference standards has never been more critical. Aquigen Bio, a trusted provider of pharmaceutical reference materials, is proud to announce the availability of Doxorubicin Dimer Impurity 3, a key impurity used in the impurity profiling of the widely used chemotherapeutic agent, Doxorubicin.

This launch is part of Aquigen Bio's expanded portfolio of Doxorubicin impurity standards, developed to support stringent analytical requirements and regulatory filings for pharmaceutical manufacturers and research organizations around the globe.

What Is Doxorubicin Dimer Impurity 3?
https://aquigenbio.com/product/doxorubicin-dimer-impurity-3/

Doxorubicin Dimer Impurity 3 is a structural byproduct that forms during the synthesis or degradation of Doxorubicin, an anthracycline antibiotic used in the treatment of cancers such as leukemia, breast cancer, and lymphoma. This impurity is generated through oxidative coupling reactions between two Doxorubicin molecules, forming a dimer that may impact the safety, efficacy, and shelf life of the drug product.

With regulatory bodies such as the US FDA, EMA, and CDSCO demanding rigorous impurity profiling, identifying and quantifying dimeric impurities like Doxorubicin Dimer Impurity 3 is essential for regulatory submissions and ensuring product safety.

For analytical chemists and formulation scientists, having access to a well-characterized impurity standard is critical for:
HPLC/UPLC method development and validation
Forced degradation studies
Stability testing
Toxicological assessment

Why Choose Aquigen Bio's Doxorubicin Dimer Impurity 3?
Aquigen Bio delivers this impurity standard with a commitment to scientific excellence and regulatory compliance. Each batch of Doxorubicin Dimer Impurity 3 is synthesized in controlled environments and undergoes stringent quality control and characterization.
Key features include:
≥ 95% purity verified by HPLC and NMR
Detailed Certificate of Analysis (CoA) with spectral data (LC-MS, NMR, IR)
Globally accepted documentation standards
Custom packaging available
Rapid international shipping with cold chain logistics as needed

Aquigen Bio's robust infrastructure, which includes cGMP-compliant synthesis and analytical labs, enables the company to offer consistent, high-quality impurity standards that meet both R&D and regulatory submission needs.

Explore the product in detail: Doxorubicin Dimer Impurity 3

A Full Suite of Doxorubicin Impurity Standards
Aquigen Bio understands that a single impurity standard rarely suffices for a complete analytical profile. To support comprehensive testing and validation, the company offers a broad spectrum of Doxorubicin-related impurity standards, including:
Doxorubicin Dimer Impurity 1 -
https://aquigenbio.com/product/doxorubicin-dimer-impurity-1/
A closely related structural isomer used to assess side reactions and impurity build-up during synthesis or formulation.

Doxorubicin Dimer Impurity 2 -
https://aquigenbio.com/product/doxorubicin-dimer-impurity-2/
Used in stability studies and toxicological risk assessments for advanced Doxorubicin formulations.

These impurities, along with Doxorubicin Dimer Impurity 3, are part of Aquigen's specialized category of Doxorubicin impurity standards that support analytical development, method validation, and regulatory submissions worldwide.

Regulatory Compliance and Documentation
Pharmaceutical companies must ensure that all impurity standards used in their testing protocols meet internationally accepted criteria. Aquigen Bio aligns its manufacturing and quality control practices with ICH Q3A/B, USP, and Ph. Eur. guidelines, delivering reference materials that support:
Drug Master File (DMF) submissions
New Drug Applications (NDAs)
ANDA filings
GMP audits and inspections

Each impurity standard is supplied with a full suite of analytical documentation, including:
COA (Certificate of Analysis)
NMR, MS, IR spectra
HPLC chromatogram
Stability and storage data

This comprehensive documentation simplifies both internal QC processes and external audits or regulatory queries.

Applications Across the Drug Development Pipeline
The availability of high-purity dimer impurities like Doxorubicin Dimer Impurity

Explore Doxorubicin Impurities
https://aquigenbio.com/products/impurity-standards/doxorubicin/

3 facilitates critical pharmaceutical functions:

Method Development: Establishing sensitive, specific methods for impurity detection and quantification.

Stability Studies: Understanding the degradation pathways of Doxorubicin under various environmental conditions.

Quality Control: Monitoring batch-to-batch consistency of active pharmaceutical ingredients (APIs) and finished products.

Toxicological Studies: Assessing the safety of trace-level impurities that could pose potential risks to patients.

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 global leader in pharmaceutical impurity reference standards, offering a comprehensive catalog that spans APIs, degradation products, metabolites, and custom synthesis services. Headquartered in Hyderabad, India, Aquigen Bio serves clients in over 30 countries, including regulatory agencies, pharmaceutical manufacturers, CROs, and academic research institutions.
With a mission to support precision, safety, and scientific innovation, Aquigen Bio continues to invest in cutting-edge analytical capabilities, world-class talent, and stringent quality systems.

This release was published on openPR.