Press release
Understanding Resmetirom Impurity 22: A Key to Ensuring Drug Safety and Quality
In the pharmaceutical development process, understanding and controlling impurities is not just a regulatory requirement-it's a cornerstone of patient safety and product efficacy. One impurity garnering increasing attention is Resmetirom Impurity 22, a compound associated with the synthesis of Resmetirom, a promising drug candidate for nonalcoholic steatohepatitis (NASH). This article delves into the significance of Resmetirom Impurity 22, its analytical characterization, implications for pharmaceutical quality control, and how leading suppliers like Aquigen Bio are ensuring its availability for research and validation.To know more Resmetirom Impurity 22
https://aquigenbio.com/product/resmetirom-impurity-22/
What Is Resmetirom and Why Does It Matter?
Resmetirom, known chemically as MGL-3196, is a selective thyroid hormone receptor-beta (THR-β) agonist. It has been developed as an oral treatment for NASH-a progressive liver disease characterized by fat accumulation, inflammation, and fibrosis. With millions worldwide affected and limited therapeutic options, Resmetirom offers hope as a disease-modifying treatment.
The drug's mechanism hinges on selectively stimulating hepatic THR-β receptors to reduce liver fat, improve lipid metabolism, and alleviate fibrosis without triggering systemic hyperthyroidism. This precision makes the purity and stability of the compound, including any associated impurities like Impurity 22, critical for clinical success.
To know more Resmetirom Impurity 19
https://aquigenbio.com/product/resmetirom-impurity-19/
The Role of Impurities in Pharmaceutical Development
Impurities are substances within a pharmaceutical compound that are not the active drug substance. They may arise during synthesis, storage, or degradation and can include by-products, residual solvents, or degradation products.
According to ICH guidelines (especially Q3A and Q3B), all significant impurities-those above certain thresholds or with potential safety concerns-must be identified, quantified, and controlled. Understanding impurities is essential for:
Ensuring safety by identifying any potentially toxic or reactive substances.
Achieving regulatory approval through comprehensive impurity profiling.
Enhancing stability and shelf life of the pharmaceutical product.
Maintaining therapeutic efficacy by avoiding compound interference.
Introducing Resmetirom Impurity 22
Chemical Identity
Chemical Name: Ethyl (2-cyanoacetyl)carbamate
Molecular Formula: C6H8N2O3
CAS Number: 6629-04-5
Molecular Weight: 156.14 g/mol
Structure: Characterized by the presence of a cyano group and a carbamate moiety.
To know more about Resmetirom Impurity 18
https://aquigenbio.com/product/resmetirom-impurity-18/
This impurity may be formed during one of the intermediate synthesis steps of Resmetirom, potentially as a result of incomplete reactions or side-chain degradation. It is a structurally distinct compound that requires close monitoring due to the potential for biological activity or toxic effects.
Analytical Challenges and Techniques
Detecting Resmetirom Impurity 22 with accuracy is paramount in pharmaceutical manufacturing. Given its chemical structure, which includes a polar nitrile and an ester-linked carbamate, advanced analytical methods are necessary. The most common techniques include:
1. High-Performance Liquid Chromatography (HPLC)
This is the primary tool used for impurity separation and quantification. Specialized columns and mobile phases are selected to ensure peak resolution between Resmetirom and its impurities.
2. Mass Spectrometry (MS)
Used in tandem with HPLC (LC-MS), MS allows for exact mass confirmation and fragmentation pattern analysis, especially important when identifying unknown or trace-level impurities.
3. Nuclear Magnetic Resonance (NMR) Spectroscopy
For structural confirmation, NMR provides definitive data on the atomic connectivity of the impurity, especially in regulatory submissions.
4. Fourier Transform Infrared Spectroscopy (FTIR)
FTIR helps confirm the presence of functional groups like nitriles and carbamates, giving supportive data during impurity profiling.
Regulatory Perspective on Impurity 22
According to global regulatory bodies like the FDA, EMA, and ICH, any impurity present above 0.1% in a drug substance must be identified and qualified, unless otherwise justified. For mutagenic impurities or those suspected of genotoxicity, even lower thresholds apply (as low as 1.5 μg/day intake).
While Resmetirom Impurity 22 may not be genotoxic, its structural features-particularly the cyano group-necessitate evaluation through:
QSAR (Quantitative Structure-Activity Relationship) modeling
In vitro genotoxicity assays (e.g., Ames test)
Toxicological risk assessment
Only after demonstrating a safe toxicological profile can this impurity be accepted within permissible limits in the drug product.
Aquigen Bio's Contribution to Research and Compliance
Aquigen Bio stands at the forefront of impurity reference standard supply. Their high-purity Resmetirom Impurity 22 is available to pharmaceutical developers, contract research organizations (CROs), and analytical labs engaged in method validation and regulatory submission.
Key Features of Aquigen Bio's Product:
Purity Standards: ≥ 98% purity (HPLC)
Availability: Custom pack sizes to support various stages of R&D
Documentation: Accompanied by Certificate of Analysis (CoA), NMR, and MS data
Storage and Handling: Shipped under recommended conditions to ensure stability
For more information, you can explore the product here: Aquigen Bio - Resmetirom Impurity 22
Applications of Resmetirom Impurity 22
The impurity is used for various critical applications in pharmaceutical development:
Method Validation: Ensures analytical procedures can accurately and reproducibly detect and quantify the impurity.
Stability Testing: Determines if and how the impurity forms under accelerated and long-term storage conditions.
Forced Degradation Studies: Helps simulate extreme conditions (light, heat, pH) to identify degradation pathways.
Toxicological Studies: Enables standalone evaluation of the impurity's biological impact.
Regulatory Submissions: Essential for dossier completion when submitting new drug applications (NDAs) or Investigational New Drug (IND) filings.
Ensuring Patient Safety Through Vigilant Impurity Control
Even trace-level impurities can have outsized effects on drug performance and patient safety. The meticulous characterization and control of impurities like Resmetirom Impurity 22 ensures that patients receive therapies that are not only effective but also safe for long-term use.
Pharmaceutical companies are investing heavily in predictive impurity profiling, green chemistry to reduce impurity formation, and real-time monitoring tools. These advancements, coupled with reliable reference standards, are raising the bar for drug quality globally.
Conclusion
Resmetirom represents a breakthrough in treating liver diseases like NASH, but its success depends heavily on robust impurity management. Resmetirom Impurity 22, though a minor component by quantity, plays a major role in determining the safety, compliance, and integrity of the final drug product.
Thanks to trusted suppliers like Aquigen Bio, access to high-purity impurity reference standards is no longer a bottleneck in drug development. By ensuring precise characterization and control of impurities, the pharmaceutical industry continues its mission of delivering safe, high-quality therapies to patients worldwide.
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 the leading resource in India for Venetoclax Impurity Standards. Recognized for its unparalleled expertise in reference materials and pharmaceutical impurities, Aquigen supports researchers and manufacturers in overcoming critical challenges in impurity identification and quantification. With a steadfast commitment to scientific precision and quality, Aquigen Bio Sciences aids cutting-edge pharmaceutical innovation that ensures safer therapeutics for global healthcare.
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