Aquigen's Fusidic Acid EP Impurity Standards - High-Purity Reference Materials for Impurity A, B & C | Analytical-Grade Standards for QC, Method Validation, Stability Testing, and Regulatory Compliance in Pharmaceutical Applications

Aquigen presents its comprehensive suite of Fusidic Acid EP Impurity reference standards-Impurity A, Impurity B, and Impurity C. Each is meticulously synthesized, fully documented, and pharmacopeial‐grade, catering to analytical labs, pharmaceutical manufacturers, and regulatory filings across geographies.

Explore Fusidic Acid Impurities
https://aquigenbio.com/products/impurity-standards/fusidic-acid/

The Importance of Fusidic Acid Impurities
Fusidic acid, derived from Fusidium species, is a potent antibiotic with bacteriostatic activity against Gram‐positive bacteria. During drug manufacturing and stability testing, degradation or side‐reactions can yield impurity forms that must be monitored and controlled to meet European Pharmacopoeia (EP) and global regulatory standards.

Aquigen's Impurity A, B, and C are precisely those EP‐designated impurities, ideal for:
Method development and validation
Quality control (QC) release testing
ANDA or DMF filings
Stability and impurity profiling studies

These standards ensure accurate quantification and reliable traceability, supporting compliance under stringent regulatory frameworks.
Fusidic Acid EP Impurity A
https://aquigenbio.com/product/fusidic-acid-ep-impurity-a/

Product name: Fusidic Acid EP Impurity A
Chemical identity: 24,25‐Dihydroxy Fusidic Acid
Molecular formula / weight: C31H50O8 / ~550.72
CAS number: 80445‐74‐5

Status: Pharmacopeial impurity A for Fusidic Acid EP
Applications: Essential for calibrating HPLC or LC‐MS impurity assays, performing forced degradation studies, and setting acceptance criteria aligned with EP standards.

Fusidic Acid EP Impurity B
https://aquigenbio.com/product/fusidic-acid-ep-impurity-b/

Product name: Fusidic Acid EP Impurity B
Chemical identity: 24,25‐Dihydro‐24,25‐dihydroxy‐fusidic Acid‐21,25‐lactone
Molecular formula / weight: C31H48O7 / ~532.71
CAS number: Not assigned (NA)

Status: Recognized EP impurity B species
Applications: Widely used in analytical QC for identifying lactone and degradation forms, and useful in impurity profiling according to pharmacopeial thresholds.

Fusidic Acid EP Impurity C
https://aquigenbio.com/product/fusidic-acid-ep-impurity-c/

Product name: Fusidic Acid EP Impurity C
Chemical identity: (24R)‐24,25‐dihydro‐24,25‐dihydroxy‐fusidic Acid 21,24‐lactone
Molecular formula / weight: C31H48O7 / ~532.71
CAS number: NA

Status: EP‐recognized lactone impurity C form
Applications: Imperative for differentiating stereoisomeric lactone impurities during method validation, routine QC, and forced degradation assessment.

Why Choose Aquigen?
Regulatory Grade & Complete Documentation
Aquigen's standards include COA, chromatographic data, structural characterization, and stability profiles. All documentation adheres to pharmacopeial standards and supports regulatory filings such as ANDA, DMF, and ICH compliance.

Analytical Performance & Consistency
These standards are manufactured under strict controlled conditions, ensuring batch‐to‐batch consistency. Laboratories worldwide rely on them to accurately quantify Fusidic Acid impurity levels and maintain traceable QC systems.

Availability & Lead Time
Aquigen maintains stock-ready availability with rapid dispatch capabilities. This ensures labs meet tight regulatory timelines without delays in sourcing reference standards.

Global Support & Service
Aquigen offers worldwide delivery, responsive customer support, and quick quoting processes, ensuring seamless procurement and documentation.

Application Use Cases
Method Development & Validation: Utilize fusidic acid impurities to establish retention time, relative retention factors (RRT), and detection limits.

Forced Degradation Studies: Simulate stress conditions (light, heat, humidity) and use impurity standards to confirm degradation profiles.

Quality Control Testing: Batch release testing against EP impurity limits as per stability storage protocols.

Regulatory Submissions: Ensure traceable documentation and impurity identity for ANDA, DMF, and new drug regulatory filings.

Ordering & Customer Convenience
Inquiry & Quotation: Available via the individual product pages. Aquigen ensures rapid response and custom quotation for required quantities.

Bulk Synthesis Support: Ideal for scale‐up labs needing impurity standards in milligram to multi‐gram quantities.

Documentation Packages: COA, certificate of analysis data, MSDS, sourcing information, suitable for regulatory audit trails.

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 is a trusted global supplier of high-purity pharmaceutical reference standards, impurity markers, and fine chemicals. With a strong focus on quality, regulatory compliance, and scientific precision, we support pharmaceutical companies, analytical labs, and research institutions in their efforts to meet international pharmacopeial standards. Our product portfolio spans across APIs, EP/USP impurities, and custom synthesis, all backed by detailed characterization data and responsive customer support. At Aquigen, we are committed to delivering reliable solutions that enable safer, more effective medicines worldwide.

This release was published on openPR.