Aquigen Bio Enhances Oncology Research with High-Quality Ibrutinib Impurity Standards

Aquigen Bio, a trusted name in impurity reference standards, has expanded its portfolio to include a comprehensive range of Ibrutinib impurity standards. These high-purity compounds support pharmaceutical companies, research labs, and contract research organizations (CROs) in developing and validating robust analytical methods for Ibrutinib, a BTK inhibitor widely used in cancer treatments such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma.

As regulatory agencies like ICH, USFDA, and EMA enforce increasingly stringent quality standards, the demand for certified impurity profiling materials has surged. Ibrutinib, like many APIs, can generate trace impurities during synthesis or storage. Identifying and quantifying these impurities is vital for ensuring patient safety, formulation stability, and regulatory compliance.
"Our Ibrutinib impurity standards are crafted with over 95% purity and come with complete analytical documentation including COA, NMR, MS, and HPLC data," said a spokesperson from Aquigen Bio. "Whether for method development, forced degradation studies, or stability testing, our solutions ensure precision and consistency across every research phase."

Featured Ibrutinib Impurity Standards:
Ibrutinib Impurity 2: Ideal for regulatory submissions and impurity profiling.
https://aquigenbio.com/product/ibrutinib-impurity-2/

Ibrutinib Impurity 13: Includes detailed chromatographic and spectral data.
https://aquigenbio.com/product/ibrutinib-impurity-13/

Ibrutinib Impurity 14: Custom pack sizes available for development needs.
https://aquigenbio.com/product/ibrutinib-impurity-14/

Ibrutinib Impurity 15: Widely used in forced degradation studies.
https://aquigenbio.com/product/ibrutinib-impurity-15/

Ibrutinib Impurity 16: Known for its high thermal and storage stability.

Ibrutinib Impurity 19: Tested to meet international pharmacopeia standards.

Ibrutinib Impurity 20: Supported by spectral interpretation assistance.

Ibrutinib Impurity 21: Reliable for long-term stability and method validation.

Ibrutinib Impurity 22: Enables reproducible QC and R&D outcomes.

Why Aquigen Bio Stands Out:
>95% purity across all standards

Comprehensive documentation for every lot

Customizable packaging options (mg to gram scale)

Fast international delivery

Trusted by global pharma, CROs, and CDMOs

Use Cases Across the Development Lifecycle:
Stability Testing

Analytical Method Development

Regulatory Compliance Support

Degradation Pathway Analysis

Toxicological Risk Assessment

Aquigen Bio's impurity standards align with evolving global regulations, helping teams achieve reliable, reproducible, and regulator-ready data for Ibrutinib and related oncology APIs.

Aquigen Bio Sciences
281/1, Plot No 41,
Hinjawadi - Pirangut Rd,
Kasar Amboli, Pirangut,
Pune, Maharashtra 412108
Visit: www.aquigenbio.com

Aquigen Bio is a leading provider of certified reference standards, impurity profiling compounds, and research chemicals to pharma, biotech, and academic institutions worldwide. With a dedication to excellence and a focus on regulatory readiness, Aquigen empowers scientists to innovate with confidence.

This release was published on openPR.