Isotope Science / Alfa Chemistry

Analytical Characterization

The incorporation of deuterium atoms into drug molecules can profoundly impact their biological properties. However, these benefits can only be realized when deuterium incorporation is precise and well-characterized. At Alfa Chemistry, we provide a comprehensive range of analytical characterization services to characterize the successful development and regulatory approval of deuterated drugs. By leveraging cutting-edge instrumentation and a team of seasoned experts, we ensure to deliver reliable, accurate data.

Our Analytical Characterization Services

Alfa Chemistry offers a full suite of analytical services tailored to the specific requirements of deuterated drug development, including:

  • Deuteration Rate Determination: One of the foundational and important aspects of deuterated drug development is the confirmation of deuterium incorporation. We utilize advanced analytical techniques such as nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS) to determine deuteration rate accurately.
  • Structural and Chemical Purity Characterization: Ensuring the structure of deuterated compounds is critical. We employ high-resolution techniques like Fourier-transform infrared (FTIR) spectroscopy, high-performance liquid chromatography (HPLC), and tandem MS to confirm molecular structure and chemical purity.
  • Impurity Profiling Study: Impurities can impact drug safety and efficacy. Our impurity profiling includes isotopic impurity characterization and non-deuterated analogs' detection, ensuring regulatory compliance.
  • Stability Testing: Stability are critical parameters for drug development. Our stability testing includes evaluations under diverse conditions, such as temperature variations, light exposure, and humidity. This ensures the compound retains its integrity over time, meeting the stringent requirements of regulatory agencies.
  • Custom Analytical Method Development: For complex molecules or unique formulations, we develop and validate bespoke analytical methods, ensuring robust and reproducible results.
  • ...

Key Instruments

  • 600 MHz NMR Spectrometer
  • FTIR Spectroscopy
  • UHPLC System
  • Stability Chambers
  • Orbitrap Mass Spectrometer
  • Liquid and Gas Chromatography (LC/GC)
  • X-ray Crystallography
  • ...

Why Partner with Us?

Cutting-Edge Technology: We continuously invest in the latest analytical instruments, ensuring our clients benefit from the most advanced tools available.

Comprehensive Reporting: Our detailed, transparent reporting ensures that clients receive actionable insights, enabling informed decision-making.

Rapid Turnaround Time: Our streamlined processes ensure that clients receive high-quality data promptly, enabling faster decision-making.

In the competitive landscape of drug development, precise and reliable analytical characterization is essential for the success of deuterated drugs. Our company is committed to providing top-tier services that empower researchers to unlock the full potential of these innovative compounds. From deuterium content verification to stability testing, our comprehensive services and expert team ensure your project progresses seamlessly from concept to market. Choose us as your trusted partner in deuterated drug development, and experience the difference that cutting-edge technology and unparalleled expertise can make. For additional details about our services or to discuss your analytical characterization requirements for deuterated drug, please reach out to us directly.

Please kindly note that our products and services are for research use only.
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