Elevate Pharmaceutical R&D with Aquigen BioSciences' Precision‐Grade Flibanserin Impurity B: Custom Synthesis, Unmatched Purity, ANDA‐Ready Reference Standard to Drive Analytical Method Development and Regulatory Compliance

Flibanserin Impurity B is a reference standard used in pharmaceutical research and development. It is primarily applied during the analysis and validation of drug substances to identify, quantify, and control impurities that may be present in the final product. This impurity is associated with the parent compound, Flibanserin, a medication approved for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
Aquigen BioSciences offers Flibanserin Impurity B as a part of its impurity standards product line, which supports regulatory filings, such as Abbreviated New Drug Applications (ANDAs), method development, and quality control processes.
Explore Flibanserin Impurity B
https://aquigenbio.com/product/flibanserin-impurity-b/

Product Details
Product Name: Flibanserin Impurity B
Catalog No.: AQ-F004811
Molecular Formula: C21H24N4O3
Molecular Weight: 380.5
Application: For analytical use only. Not intended for human consumption.
Availability: Currently available on backorder.
COA & Documentation: Certificate of Analysis available for download from the product page.

Usage and Applications
Flibanserin Impurity B is used in pharmaceutical laboratories during:
Impurity Profiling: Detecting and identifying trace-level impurities in the Flibanserin active pharmaceutical ingredient (API).
Analytical Method Development: Developing and validating analytical methods for drug testing.
Stability Testing: Studying how impurities form over time in storage or under stress conditions.

Quality Control: Ensuring that impurity levels are within acceptable regulatory limits.
The impurity standard allows manufacturers to establish specifications and meet requirements from regulatory authorities such as the US FDA or EMA during drug approval processes.
Storage and Handling
As with all chemical reference standards, Flibanserin Impurity B must be handled with proper safety precautions. It is intended for use by trained laboratory professionals in controlled environments.
Key points for handling:
Use appropriate personal protective equipment (PPE).

Store in a cool, dry place, away from direct sunlight and incompatible substances.
Follow laboratory safety protocols for storage and disposal.
Refer to the Safety Data Sheet (SDS) for detailed safety and handling instructions.

Flibanserin Impurity C
https://aquigenbio.com/product/flibanserin-impurity-c/

Another impurity standard offered in this series is Flibanserin Impurity C, which is also used in similar analytical workflows.

Product Details
Product Name: Flibanserin Impurity C
Catalog No.: AQ-F004812
Molecular Formula: C20H22N4O3
Molecular Weight: 366.4
Application: Analytical reference standard. Not for human use.

Flibanserin Impurity C supports broader impurity profiling and is useful in situations where multiple impurity markers are analyzed simultaneously. This helps ensure the robustness and accuracy of the analytical method.
Flibanserin Impurity Standards - Product Category
Aquigen BioSciences provides a full range of impurity standards related to Flibanserin. These impurities are used by pharmaceutical labs and contract research organizations (CROs) worldwide for ensuring that drug formulations meet required safety and efficacy criteria.
The category includes:
Impurity reference standards for drug substances

Custom synthesis options for unavailable or rare impurities

Products available with full documentation, including Certificate of Analysis and SDS

Explore the full category here:
https://aquigenbio.com/products/impurity-standards/fibanserin/

Key Benefits of Using Flibanserin Impurity Standards
Regulatory Compliance: Supports data required for ANDA submissions and other regulatory filings.

Analytical Accuracy: Enables precise identification and quantification of impurities.
Consistency: Manufactured under controlled conditions to ensure batch-to-batch consistency.
Documentation: Comes with COA, SDS, and other essential quality documents.
Custom Synthesis Options: Available upon request if standard is on backorder or requires specific modifications.

Ordering and Custom Requests
Flibanserin Impurity B is available for ordering through Aquigen BioSciences' website. While currently listed as on backorder, customers can request synthesis or inquire about lead time directly through the product page.
For bulk orders, documentation requests, or technical inquiries, users can contact the Aquigen team through the contact form available on the website.
Safety and Legal Disclaimer
All products, including Flibanserin Impurity B and Flibanserin Impurity C, are:
Supplied for laboratory and research use only.

Not intended for human or veterinary use.
To be used only by qualified professionals in a lab environment.
Please consult the Certificate of Analysis and SDS before using the product.

Summary
Flibanserin Impurity B is an essential reference standard used in pharmaceutical development and regulatory testing related to Flibanserin drug substances. It is a valuable component of impurity profiling, method validation, and quality assurance workflows. Alongside related products like Flibanserin Impurity C, it offers comprehensive support for pharmaceutical R&D and manufacturing processes.

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 Sciences
Aquigen Bio Sciences is at the forefront of pharmaceutical excellence, serving as the leading resource for Flibanserin Impurity standards in India. With a strong commitment to safety, innovation, and regulatory compliance, the organization specializes in impurity profiling, synthesis, and analysis, empowering pharmaceutical manufacturers globally with premier standards. Aquigen Bio Sciences' dedication to cutting-edge research ensures it remains a trusted partner in refining quality benchmarks across the pharmaceutical landscape.

This release was published on openPR.