Pharmaceutical Structure Characterization Service
Pharmaceutical structure characterization is a core step in modern drug development. It plays a critical role in confirming molecular structures, identifying crystal forms, assigning impurities, validating stereochemistry, and evaluating formulation consistency. Whether for new drug development, generic drug equivalence studies, quality control, or regulatory submission, accurate and comprehensive structure characterization is foundational to ensuring drug safety and efficacy.
As a specialized CRO platform focusing on molecular analysis and structure elucidation, MtoZ Biolabs offers high-quality and traceable Pharmaceutical Structure Characterization Service. Leveraging a comprehensive suite of chromatography, mass spectrometry, spectroscopy, and crystallographic platforms, we provide pharmaceutical companies, biotech firms, and academic institutions with integrated solutions. Our systematic technical integration and scientific process control enable clients to obtain clear structural insights efficiently throughout their drug development journey.
Services at MtoZ Biolabs
Our pharmaceutical structure characterization service encompass multi-dimensional analytical techniques to help clients examine pharmaceutical compounds at different structural levels:
X-ray Crystal Diffraction Analysis Service
Offers atomic-resolution insights into the 3D spatial structure, absolute stereochemistry, and crystal packing. It is the gold standard for crystal form confirmation and molecular configuration determination.
Ultraviolet Photoelectron Spectrometer (UPS) Analytical Service
Analyzes HOMO/LUMO energy levels and electronic structures, useful for studying molecular reactivity and predicting electronic behavior.
Fourier Transform Infrared Spectroscopy (FTIR) & Raman Spectroscopy Analytical Service
Detects functional groups, hydrogen bonding, and molecular conformational differences; suitable for crystal form analysis and excipient consistency verification.
Nuclear Magnetic Resonance (NMR) & Solid-State NMR Testing Service
Clarifies functional group connectivity, isomerism, and internal molecular environments, supporting structural validation and impurity profiling.
Enables qualitative and quantitative impurity analysis, purity determination, and detection of thermally stable small molecules; ideal for impurity profiling and process control.
Offers high-sensitivity analysis of molecular weights and structural fragments, applicable to degradation products, metabolites, impurities, and intermediates.
Suitable for high-molecular-weight drugs such as peptides, polymers, and proteins, providing distribution profiles and molecular weight information.
Steady-state/Transient Fluorescence Spectrometer Testing Service
Assesses excited-state behavior and photophysical properties, ideal for labeled compounds, target-binding studies, and imaging-related applications.
Analysis Workflow
Service Advantages
1. Integrated Platforms
MtoZ Biolabs integrates XRD, NMR, MS, FTIR, Raman, and other mainstream analytical techniques, supporting a wide range of sample forms including crystals, liquids, and solids. Cross-validation across platforms ensures robust and multi-dimensional structural analysis, from small molecules to complex drug entities.
2. Comprehensive Insights
Our analytical coverage spans macro-level crystal analysis to micro-level conformational and electronic structure characterization. Multi-layered data integration supports polymorph identification, isomer differentiation, and conformation evaluation, enhancing the depth and reliability of structural conclusions.
3. Standardized Processes
All projects follow SOP-based workflows—from initiation and sample handling to testing and reporting. Our standardized, traceable documentation supports internal review, technical filing, and regulatory submissions with clarity and compliance.
4. Professional Team
Our analysts possess interdisciplinary expertise in pharmaceutical chemistry, organic synthesis, and materials science. We offer customized technical guidance, design efficient workflows, and provide responsive communication throughout the project.
5. Extended Services
Beyond structure characterization, we support impurity analysis, polymorph screening, and formulation consistency studies. We offer seamless integration with related modules to enhance project efficiency and continuity across drug discovery and development stages.
Applications
1. Structural confirmation of new molecular entities (NMEs)
2. Crystal form analysis and impurity profiling for APIs
3. Structural identification of intermediates and degradation products
4. Comparative analysis in generic drug equivalence studies
5. Structural profiling of peptides, polymers, and biologics
6. Consistency evaluation of raw materials and formulations
FAQ
Q1: Can you analyze amorphous or poorly soluble samples?
Yes. We utilize solid-state NMR, Raman spectroscopy, and other suitable methods for amorphous or non-crystalline substances.
Q2: Can you perform crystal form screening?
Yes. We provide crystal form comparison and polymorph analysis under various solvent and crystallization conditions.
Q3: Do you accept unstable or air-sensitive samples?
Yes, but please discuss sample properties with us beforehand so we can advise on suitable packaging and handling conditions.
Q4: I’m unsure which technologies to select. Can you help?
Absolutely. Share your research objectives and sample details with us—we will recommend appropriate analytical techniques and strategies.
Sample Submission Suggestions
1. Sample Types: Small molecules, intermediates, impurities, crystals, solid powders, raw materials, biologics, etc.
2. Recommended Quantity: ≥5 mg for solids, or ≥1 mL of solution (concentration ≥1 mg/mL).
3. Storage Conditions: Freeze or store in a cool, dry environment; avoid repeated freeze-thaw cycles.
4. Transport Conditions: Use dry ice or ice packs; inert atmosphere protection is recommended for sensitive samples.
Contact our team for personalized submission guidance!
Deliverables
1. Technical Analysis Report: Includes methods, parameters, conditions, raw spectra, structural interpretation, and analysis summary.
2. High-Resolution Spectrum Files: NMR (1D/2D), FTIR, Raman, MS, XRD data—depending on techniques used.
3. Structural Model Files: 3D structure files (.cif or .mol) and stereochemistry information, if applicable.
4. Project Summary Memo: Outlines key decision points and strategies for traceability and internal documentation.
5. Optional Deliverables: Method validation data, quantitative results, or bilingual reports available upon request.
For specific regulatory or documentation formats, we offer customized output tailored to your requirements.
Pharmaceutical structure characterization is essential for understanding molecular identity, ensuring product quality, and meeting regulatory standards. At MtoZ Biolabs, we combine state-of-the-art analytical platforms, experienced personnel, and rigorous workflows to support reliable, high-quality Pharmaceutical Structure Characterization Service. To learn more about our services, feel free to contact us for customized consultation and solutions.
How to order?