Rivaroxaban Impurity A CAS 931204-39-6: Structure, Analysis, and Pharmaceutical Quality Control
Detailed insights into a critical impurity in Rivaroxaban production, ensuring drug safety and efficacy.
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Rivaroxaban Impurity A
This product, identified as Rivaroxaban Impurity A with CAS number 931204-39-6, is crucial for ensuring the quality and safety of Rivaroxaban, a widely used anticoagulant. Its precise characterization and detection are vital for pharmaceutical manufacturing and regulatory compliance.
- Understanding the structure of this key Rivaroxaban impurity is essential for robust drug synthesis.
- A validated RP-HPLC method has been developed for accurate quantification of this Rivaroxaban impurity.
- Utilizing advanced techniques like mass spectrometry, FT-IR, and NMR, the impurity's structure was elucidated.
- In silico analysis suggests no mutagenicity, contributing to patient safety in Rivaroxaban therapies.
Advantages Offered
Enhanced Drug Purity
The rigorous characterization and quantification of this Rivaroxaban impurity help in achieving higher API purity, a cornerstone of pharmaceutical quality.
Regulatory Compliance
Adherence to ICH guidelines for drug impurity analysis is facilitated by the validated analytical methods for Rivaroxaban impurities.
Process Optimization
Understanding the formation pathways of this Rivaroxaban impurity aids in optimizing synthesis processes to minimize its presence.
Key Applications
Pharmaceutical Research
Essential for R&D activities focused on understanding and controlling impurities in Rivaroxaban.
Quality Control
Used in QC labs for routine testing of Rivaroxaban API and finished products to ensure they meet stringent standards.
Drug Development
Crucial for Abbreviated New Drug Application (ANDA) and DMF filing, supporting the development of safe and effective Rivaroxaban formulations.
Analytical Standards
Serves as a critical reference standard for developing and validating analytical methods for Rivaroxaban impurity analysis.