Pharmaceutical Analytical Method Development and Optimization

What is Pharmaceutical Analytical Method Development and Optimization?

Analytical method development and optimization refers to a process established series analysis methods and procedures during the drug research and development process to better understand the properties of the drug, including the physical properties, chemical properties, biological properties, etc., of the drug, which ensure that the drug meets relevant quality standards and regulatory requirements.  By developing and optimizing analysis methods, we can ensure the reliability and accuracy of analysis results, provide researchers with accurate data support, help them better understand drug characteristics, and guide subsequent drug research and development. Analytical method development and optimization generally include the selection, optimization, verification and application of analytical methods in the drug development and production process for drug quality control, component analysis, purity testing, etc.

Explore Our Pharmaceutical Analytical Method Development and Optimization Services

Analytical method development and optimization is a complex and labor-intensive process that requires specific expertise to deliver accurate, selective, and robust analytical methods. CD Formulation has the ability to develop and test new analytical methods for efficient, fast, and accurate analysis of your products.

Taking into account your specific needs, we can provide you with analytical methods suitable for a variety of analytes and drug delivery systems, including small molecules, trace organics, extended-release oral solid dosage forms, semi-solid dosage forms, liquids, patches, and complex injectables, etc. We have cutting-edge technology and first-class equipment to meet your project needs.

• Gas Chromatography (GC)
• High-performance liquid chromatography (HPLC)
• Ultra-performance liquid chromatography (UPLC)
• Gas Chromatography/Mass Spectrometry (GC/MS)
• Ultraviolet/visible spectrum(UV/VIS)
• High-performance liquid chromatography/mass spectrometry (HPLC/MS)
• Ultra-performance liquid chromatography/mass spectrometry (UPLC/MS)

General Workflow of Our Pharmaceutical Analytical Method Development and Optimization Services

• Identification of target components: Our team of experts communicates with clients to identify the drug or compound for analysis, as well as the specific objectives and requirements required for the analytical method.
• Selection of HPLC/UPLC methods and systems: Based on the physical and chemical properties of the target components, select HPLC and UHPLC analytical technologies with different detection systems (DAD, MS).
• Selection a detector: Select the detection mode that is most appropriate for your drug based on the chemical nature of the analyte, potential interferences, required limits of detection (LOD) and limits of quantitation (LOQ), linear range, detector availability and/or cost.
• Selection of initial conditions and separation: Choose the most appropriate separation mode based on the solubility of your sample and the differences between the target analytes and other compounds or matrices in the sample.
• Selectivity optimization: Optimize based on method run time, run efficiency and selectivity to provide the best method for your drug.
• System optimization: Based on the above results, our team of experts will find the required balance between resolution and analysis time for your drug by optimizing parameters such as column size, particle size, and flow rate.
• Method validation: Conduct thorough method suitability testing to confirm the suitability of the method, including:

What Problem Can We Solve?

• Old method optimization: involves existing methods described in the guide that are outdated or do not meet your analytical requirements.
• New method development: involves new pharmaceutical products for which there are no valid purity determination or analytical methods.
• Mixture analysis: involves the final product being a mixture of different active ingredients.

CD Formulation is committed to creating robust and reliable pharmaceutical analysis methods to ensure the quality and safety of pharmaceuticals. Our team consists of experienced chemical analysts and pharmaceutical experts, with advanced instrumentation and professional knowledge. Whether you want to develop new methods or optimize existing old methods, we can provide professional technical support and services. Please contact us to learn more about our services and technical advantages!