Drug Structure Confirmation Service
Drug structure confirmation is a fundamental step in pharmaceutical development, ensuring that the chemical identity of an active pharmaceutical ingredient (API) or drug product is consistent with its intended design. The precise determination of molecular structure underpins the reliability of drug safety, efficacy, and quality. Any deviation in molecular identity, stereochemistry, or structural integrity can lead to altered biological activity, reduced therapeutic effectiveness, or potential safety risks. As modern pharmaceuticals often involve complex molecules, from small-molecule drugs to advanced formulations, reliable structural confirmation is essential to guide discovery, support development, and enable successful commercialization.
Service at MtoZ Biolabs
MtoZ Biolabs provides a comprehensive Drug Structure Confirmation Service that integrates advanced analytical methods to characterize atomic connectivity, stereochemistry, and molecular conformation. This service not only helps in preventing misidentified or mischaracterized compounds but also supports batch-to-batch consistency, stability testing, and overall quality assurance.
Advanced Technology Platform for Drug Structure Confirmation:
🔸Mass Spectrometry (MS)
High-resolution LC-MS and GC-MS allow precise determination of molecular weight, isotopic distribution, and fragmentation pathways, confirming molecular formula and identifying potential impurities or isomers.
🔸Ultraviolet (UV) and Infrared (IR) Spectroscopy
UV spectroscopy helps characterize conjugated systems and chromophores, while IR spectroscopy provides chemical bonds and functional group verification, ensuring accurate structural assignments.
🔸Nuclear Magnetic Resonance (NMR) Spectroscopy
One-dimensional and two-dimensional NMR experiments deliver atomic-level connectivity, stereochemical information, and conformational insights, serving as a cornerstone of structure elucidation.
🔸X-ray Single Crystal Diffraction (XRSD)
When crystalline samples are available, XRSD offers direct visualization of three-dimensional molecular structures and absolute stereochemistry with unmatched accuracy.
🔸Circular Dichroism (CD) Spectroscopy
CD analysis enables secondary structure and chiral property assessment, supporting structural confirmation of chiral drugs and conformationally sensitive molecules.
Analysis Workflow
1. Sample Preparation and Verification
Initial inspection of submitted samples to confirm suitability for structural analysis. Specific preparation steps may be required to ensure compatibility with each analytical platform.
2. Instrumental Analysis
Use of complementary analytical platforms, such as MS, NMR, IR, UV, XRSD, and CD, to generate comprehensive structural information.
3. Data Integration
Correlation and cross-validation of data from different methods to ensure accuracy and eliminate ambiguity.
4. Structural Confirmation
Compilation of results into a unified interpretation to confirm molecular identity, stereochemistry, and overall structure.
5. Reporting
Preparation of a clear, regulatory-ready report summarizing experimental approaches, results, and expert interpretation.
Service Advantages
✅Advanced multi-platform capability integrating MS, NMR, IR, UV, XRSD, and CD for comprehensive structural validation
✅High accuracy and sensitivity for detecting molecular connectivity, stereochemistry, and impurities
✅Experienced scientific team with expertise in structural elucidation and pharmaceutical analysis
✅Flexible workflows tailored to different drug substances, intermediates, and formulations
✅Efficient turnaround time supported by optimized laboratory processes and strict quality control
✅Customized analytical strategies designed to align with regional regulations, and project-specific requirements
Applications
1️⃣Verification of structural integrity for novel therapeutic compounds
2️⃣Analysis of crystal polymorphism and impurity in active pharmaceutical ingredients
3️⃣Identification of structural features in synthetic intermediates and degradation by-products
4️⃣Comparative studies to support bioequivalence assessments in generics
5️⃣Structural examination of complex molecules including peptides, polymers, and biologics
6️⃣Evaluation of consistency and reproducibility in raw materials and formulated products
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.
*Note: If you have special sample types or require additional guidance, please contact us for personalized support before sample preparation.
Deliverables
1. Comprehensive experimental details and documentation of methods used
2. Raw data files provided upon request
3. Raw spectral or chromatographic data (e.g., MS, NMR, IR, UV, XRSD, CD) depending on the analytical approach selected
4. Processed spectra, chromatograms, or diffraction patterns with basic annotations
5. Structural interpretation including molecular identity, stereochemistry, and connectivity
6. Final structural confirmation report consolidating results and expert conclusions
MtoZ Biolabs' Drug Structure Confirmation Service provides comprehensive, regulatory-ready structural validation using state-of-the-art platforms and expert scientific support. Our services help clients safeguard product integrity, minimize risks. Free project evaluation, welcome to learn more details!
Related Services
In-situ Infrared Spectroscopy Analytical Service
Nuclear Magnetic Resonance (NMR) Testing Service
How to order?
