Comprehensive Insight into Resmetirom Impurity 11: Analytical Standards, Regulatory Compliance, and Its Role in Pharmaceutical Quality Control and Development

In the intricate world of pharmaceutical manufacturing, ensuring the purity and safety of active pharmaceutical ingredients (APIs) is paramount. Among the various compounds under scrutiny, Resmetirom Impurity 11 has garnered attention due to its significance in the synthesis and quality control processes.

What is Resmetirom Impurity 11?
https://aquigenbio.com/product/resmetirom-impurity-11/

Resmetirom Impurity 11, identified by CAS No. 1581304-48-4, is a chemical by-product that can form during the synthesis of Resmetirom, a therapeutic agent under investigation for the treatment of non-alcoholic steatohepatitis (NASH). Understanding and controlling such impurities is crucial to ensure the safety and efficacy of the final pharmaceutical product.

Chemical Profile
Chemical Name: N-(3,5-Dichloro-4-((6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)benzamide
Molecular Formula: C17H11Cl2N3O3
Molecular Weight: 376.2 g/mol

This impurity is characterized by its specific molecular structure, which includes dichlorophenyl and pyridazinyl groups, contributing to its unique chemical properties.

Know more about Resmetirom category:
https://aquigenbio.com/products/impurity-standards/resmetirom/

Role in Pharmaceutical Development
The presence of impurities like Resmetirom Impurity 11 can arise from various stages of the drug development process, including:

Synthesis Intermediates: By-products formed during chemical reactions.
Degradation Products: Compounds resulting from the breakdown of the active ingredient over time.
Contaminants: Unintended substances introduced during manufacturing or handling.

Identifying and quantifying such impurities is essential to assess their impact on the drug's safety and efficacy.

Analytical Methods for Impurity Detection
To detect and quantify Resmetirom Impurity 11, several analytical techniques are employed:
High-Performance Liquid Chromatography (HPLC): Utilized for separating and quantifying impurities.

Mass Spectrometry (MS): Provides detailed information on the molecular structure of impurities.

Nuclear Magnetic Resonance (NMR) Spectroscopy: Offers insights into the molecular framework and purity levels.

These methods are integral to ensuring that the levels of impurities remain within acceptable limits, thereby safeguarding patient health.

Know more about :
1. Resmetirom Impurity 12
https://aquigenbio.com/product/resmetirom-impurity-12/
2. Resmetirom Impurity 13
https://aquigenbio.com/product/resmetirom-impurity-13/

Regulatory Considerations
Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require comprehensive impurity profiles as part of the drug approval process. These profiles must detail all identified impurities, their potential impact on drug safety and efficacy, and the methods used to control them. Failure to detect and control such impurities can lead to:
Product Recalls: Withdrawal of the product from the market due to safety concerns.

Delays in Regulatory Approval: Prolonged timelines for drug availability.
Loss of Market Reputation: Damage to the manufacturer's credibility.
Patient Safety Risks: Potential harm to patients due to unrecognized impurities.

Therefore, stringent impurity management is essential to meet regulatory standards and ensure public health safety.

Safety and Handling
Proper handling and storage of Resmetirom Impurity 11 are crucial to maintain its stability and prevent contamination. Recommended practices include:
Storage Conditions: Keep in a cool, dry place away from direct sunlight.

Personal Protective Equipment (PPE): Use gloves, goggles, and lab coats to prevent exposure.

Disposal Methods: Follow local regulations for chemical waste disposal.

Adhering to these guidelines ensures a safe working environment and the integrity of the compound.

Conclusion
Resmetirom Impurity 11 plays a significant role in the pharmaceutical development process. Through rigorous analytical methods and adherence to regulatory standards, its impact can be effectively managed. Continued research and development in this area are essential to ensure the safety and efficacy of therapeutic agents like Resmetirom.

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 Us
At Aquigen Bio, we are dedicated to advancing pharmaceutical research and development by providing high-quality impurity reference standards and analytical tools. Founded with a vision to support global healthcare innovation, we specialize in the synthesis, characterization, and supply of pharmaceutical impurities, metabolites, and custom reference materials.
With a strong focus on quality, compliance, and scientific integrity, our products are trusted by pharmaceutical companies, CROs, and regulatory agencies worldwide. Our state-of-the-art laboratory infrastructure and expert scientific team ensure that every compound we deliver meets the highest standards of accuracy and reproducibility.

This release was published on openPR.