Aquigen Biotech Launches High‐Purity Cefoxitin EP Impurity I to Strengthen Pharmaceutical Quality Control

Pune, India - July 16, 2025 - Aquigen Biotech, a global leader in high‐quality pharmaceutical reference standards, today announced the introduction of Cefoxitin EP Impurity I, a critical impurity standard defined in the European Pharmacopoeia (EP) for cefoxitin. This launch enhances Aquigen's full suite of cephalosporin impurity products and reinforces the company's commitment to aiding analytical labs, regulatory teams, and pharmaceutical manufacturers in meeting rigorous quality and safety standards.

https://aquigenbio.com/product/cefoxitin-ep-impurity-i/

1. Introduction to Cefoxitin & Its Regulatory Requirements
Cefoxitin is a second‐generation cephalosporin antibiotic widely used to treat bacterial infections. It is critically important that product formulations maintain extremely low levels of undesired chemical by‐products, known as impurities. Regulatory bodies including the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and WHO mandate strict impurity thresholds-making access to accurately characterized standards like Cefoxitin EP Impurity I indispensable.

Ensuring precise impurity quantification is vital in:
Method validation and qualification
Stability testing
Toxicological risk evaluation
Regulatory dossier submissions (DMFs, NDAs, ANDAs)

2. Cefoxitin EP Impurity I:

Definition & Analytical Significance

Cefoxitin EP Impurity I is one of several named and quantified impurities specified in the EP monograph for cefoxitin. Although typically present at trace levels, its importance cannot be overstated:
Structural precision: Reference standards ensure chromatographic identification and quantification are accurate and reproducible.

Method relevance: Used to develop and validate HPLC, LC‐MS/MS, GC, and capillary electrophoresis techniques.

Regulatory alignment: Supports compliance with ICH Q3A/B guidelines and stability testing under ICH Q1.

Aquigen's newly launched standard is synthesized and purified under stringent conditions, affording pharmaceutical and CRO customers the analytical confidence needed for both R&D and regulatory submissions.

3. Fabrication & Quality Standards of Impurity I
Aquigen Biotech adheres to transparency and high quality in all manufacturing processes:
GMP‐like production environment: Though not GMP certified, manufacturing adheres closely to regulatory best practices.

Analytical validation: Each batch is comprehensively characterized via NMR, HRMS, IR, and HPLC.

Full traceability: A Certificate of Analysis (COA) accompanies each vial, detailing purity, assay, and heavy metal content.

Robust packaging: Sealed in inert atmospheres with moisture and oxygen control to maintain long‐term stability.

These standards allow compliance with requirements for impurity standards cited in pharmacopoeial and regulatory frameworks.

4. Aquigen's Full‐Range Cefoxitin Impurity Portfolio
Complementing Impurity I, Aquigen Biotech provides an extended portfolio of cefoxitin impurities, essential for full impurity profiling and method robustness:

Cefoxitin EP Impurity A -
https://aquigenbio.com/product/cefoxitin-ep-impurity-a/
Noted during early synthesis and frequently observed under hydrolytic or oxidative stress. Ideal for forced degradation studies.

cefoxitin ep impurity b -
Commonly forms through degradation in aqueous buffers or exposure to elevated temperatures.

cefoxitin ep impurity c -
https://aquigenbio.com/product/cefoxitin-ep-impurity-c/
Used in impurity profiling and method validation during both short‐and long‐term stability testing.

cefoxitin ep impurity e -
https://aquigenbio.com/product/cefoxitin-ep-impurity-e/
Typically appears under accelerated storage conditions; vital for ICH stability studies.

By offering all these standards in-house, Aquigen ensures consistency and harmonization across impurity identification and quantification efforts for cefoxitin.

5. Applications in Analytical & Stability Testing
A. Analytical Method Development & Validation
- HPLC assay optimization: Impurity I and others help in establishing mobile phase selectivity and retention parameters.
- System suitability checks: Ensures consistent resolution and accuracy.
- LC‐MS/MS transitions: Enables sensitive detection, often required in normalization for trace levels (

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 Biotech
Aquigen Biotech is a Hyderabad‐based life‐science innovator with a mission to support pharmaceutical and academic research with top‐tier reference standards, impurity compounds, and custom synthesis services. We pride ourselves on:
Broad catalog coverage (antibiotics, anticancer agents, hormones, peptides)

Rigorous data support (spectroscopy, chromatography, purity profiles)

Global reach via efficient logistics and compliance documentation

Customer guidance and technical troubleshooting

Our goal is to streamline quality control processes, empower innovation, and reduce regulatory hurdles for our partners.

This release was published on openPR.