Pharmaceutical cGMP qNMR Service Based on 600 MHz Spectrometer

STEMart provides specialized cGMP-compliant quantitative NMR (qNMR) services for the pharmaceutical industry using advanced 600 MHz spectrometers, including the Bruker Avance Neo 600 MHz and Agilent DD2 600 MHz systems. These high-sensitivity instruments are designed to meet the rigorous standards of current Good Manufacturing Practices (cGMP), enabling precise quantification essential for drug development, quality control, and regulatory compliance. Our cGMP qNMR services support pharmaceutical research by providing accurate, reliable data on active ingredients and excipients.

Our 600 MHz NMR technology is based on nuclear magnetic resonance principles that quantify components by measuring signal intensities, directly correlating with the number of nuclei in each molecule. The high resolution of 600 MHz NMR allows for precise measurements, ensuring compliance with regulatory standards and producing high-quality data for purity analysis, concentration determination, and stability studies. Widely applied in quality assurance, formulation validation, and impurity detection, cGMP qNMR is a cornerstone in pharmaceutical analytics.

Leveraging our state-of-the-art 600 MHz spectrometers and cGMP-compliant protocols, STEMart offers a range of qNMR services tailored to meet the needs of pharmaceutical manufacturers and researchers. Our services include content uniformity testing, purity assessment, and stability analysis, providing reliable, reproducible data for regulatory submissions and product quality assurance.

What We Offer

• Purity Assessment of Active Pharmaceutical Ingredients (APIs)

High-precision qNMR analysis to verify API purity, supporting quality assurance and regulatory compliance in pharmaceutical production.

• Content Uniformity Testing

Ensures consistent distribution of active ingredients within pharmaceutical formulations, aiding in dosage accuracy and product quality control.

• Impurity Profiling and Quantification

Identifies and quantifies impurities, enabling manufacturers to meet stringent cGMP guidelines for product safety.

• Stability Testing for Formulations

Quantitative stability studies to assess the integrity of drug formulations over time, essential for shelf-life and efficacy evaluations.

• Excipient Quantification in Drug Formulations

Accurate quantification of excipients to support formulation consistency, ensuring adherence to regulatory standards.

Why Choose Us

• cGMP Compliance

Our qNMR services are fully cGMP-compliant, providing reliable data essential for regulatory submissions and quality control in the pharmaceutical industry.

• High-Resolution Sensitivity

With 600 MHz NMR systems, we deliver highly sensitive and accurate measurements, ideal for detecting low-abundance impurities in complex formulations.

• Customized Reporting and Documentation

Detailed and customizable reports meet specific project needs and regulatory requirements, supporting efficient decision-making.

• Expertise in Pharmaceutical Analysis

Our experienced team specializes in qNMR for pharmaceuticals, ensuring precise results and regulatory compliance.

Our Resources

Bruker Avance Neo 600 MHz NMR

The Bruker Avance Neo 600 MHz spectrometer provides high sensitivity and resolution, optimized for pharmaceutical qNMR applications. With TCI Cryoprobe technology, it ensures accurate quantification of APIs and excipients, meeting the stringent requirements of cGMP-compliant analyses.

Agilent DD2 600 MHz NMR System

This 600 MHz NMR system from Agilent offers robust performance for pharmaceutical quantification. Equipped with a broadband observe (BBO) probe, it supports precise cGMP-compliant measurements, including impurity profiling, stability testing, and formulation analysis.

STEMart provides high-quality NMR services tailored to meet the specific needs of our clients. Our experienced specialists use advanced equipment and follow strict quality control measures to ensure accurate and reliable results. Contact us to learn more about our NMR services and how we can help you achieve your research goals.