Aquigen Bio Expands Oncology Impurity Standards Portfolio with High-Purity Etoposide EP Impurity A

India - 07/05/2025 - Aquigen Bio, a leading provider of pharmaceutical impurity reference standards, proudly announces the launch of its latest high-quality product: Etoposide EP Impurity A. This new addition to Aquigen's growing portfolio of oncology-related impurities is tailored to meet the stringent requirements of pharmaceutical manufacturers and analytical laboratories focused on drug safety, efficacy, and compliance.

To know more about : Etoposide EP Impurity A
https://aquigenbio.com/product/etoposide-ep-impurity-a/

A Strategic Addition to Oncology Drug Development
Etoposide is a cornerstone chemotherapeutic agent widely used in the treatment of various cancers, including lung cancer, testicular cancer, lymphomas, and leukemias. As regulatory guidelines become increasingly stringent, the pharmaceutical industry demands advanced impurity profiling for such critical active pharmaceutical ingredients (APIs).

Aquigen Bio's Etoposide EP Impurity A is manufactured to support in-depth analytical studies and regulatory filings in accordance with European Pharmacopoeia (EP) standards. Impurity A represents a known and significant degradation product or synthesis-related compound in etoposide formulations, making its identification and quantification essential for ensuring product safety and therapeutic performance.

Full Characterization and Compliance

The Etoposide EP Impurity A reference standard from Aquigen Bio is supplied with:

Comprehensive Certificate of Analysis (CoA)

Detailed NMR, IR, MS, and HPLC data

High-purity material (typically >98%)

Batch-to-batch consistency

Global shipping capability with temperature-controlled packaging

By offering this level of characterization and quality assurance, Aquigen Bio helps R&D labs, quality control teams, and regulatory departments meet global standards, including ICH Q3A/B guidelines and EP monographs.
Expanding the Portfolio: Etoposide EP Impurity B Also Available
In addition to Impurity A, Aquigen Bio also offers Etoposide EP Impurity B-another critical reference standard involved in the analysis of etoposide-based products.

Know more about Etoposide EP Impurity B :
https://aquigenbio.com/product/etoposide-ep-impurity-b/

By making both impurities available, Aquigen enables comprehensive impurity profiling, aiding in:

Method development and validation

Forced degradation studies

Stability studies

Routine quality control

Regulatory submissions and drug approval pathways

These products are available through Aquigen Bio's dedicated Etoposide Impurity Standards page, where researchers can find specifications, technical support, and documentation tailored to regulatory needs.

To know more about : Etoposide Impurity
https://aquigenbio.com/products/impurity-standards/etoposide/

Why Etoposide Impurity Standards Matter
Etoposide, like many chemotherapeutic drugs, is sensitive to hydrolysis, oxidation, and temperature fluctuations. Even under controlled conditions, degradation products and synthesis intermediates can persist in the final formulation. Identifying, quantifying, and controlling these impurities is not just a regulatory necessity-it's a critical aspect of patient safety and therapeutic consistency.

Etoposide impurities, including EP Impurities A and B, are referenced in pharmacopoeial monographs and often mandated by authorities such as the EMA, US FDA, and CDSCO during drug approval processes.
Failure to detect and control such impurities can lead to:
Product recalls

Delays in regulatory approval

Loss of market reputation

Patient safety risks

Aquigen Bio's reference standards serve as essential tools to mitigate these risks by supporting robust analytical procedures.
Global Quality, Local Support
With a customer-first approach, Aquigen Bio serves clients across Europe, Asia, and the Americas, offering technical support and regulatory guidance as part of its standard service. Whether you're a generics manufacturer, formulation scientist, or regulatory affairs professional, Aquigen Bio's team helps navigate the complexities of impurity management with agility and precision.
All impurity standards are produced under stringent quality controls with ISO-certified processes and supplied with technical dossiers that simplify audits and regulatory inspections.

Customer-Centric Customization
Aquigen Bio understands that research needs vary. That's why custom pack sizes, bulk quantities, and express international shipping options are available for both Etoposide EP Impurity A and Etoposide EP Impurity B. Clients also benefit from responsive customer service, full traceability, and documentation tailored to regulatory filings, including US DMFs, CEP dossiers, and ANDA submissions.

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 an emerging leader in the field of pharmaceutical reference standards and impurity solutions. With a robust catalog of API impurities, degradants, metabolites, and working standards, the company supports pharmaceutical and biopharmaceutical clients in meeting quality, safety, and regulatory expectations.
By combining scientific expertise, advanced analytical infrastructure, and a global mindset, Aquigen Bio enables the pharmaceutical industry to develop safer, more effective drugs with confidence and speed.
Aquigen's impurity standards are trusted by:
Formulation developers

CROs and CDMOs

Generic drug manufacturers

Academic research institutions

Regulatory laboratories

For custom requirements or technical queries, contact Aquigen Bio directly through the website.

This release was published on openPR.