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Metabolite Synthesis Services for Drug Discovery
Accelerate compound evaluation, enhance translational success, and reduce research timelines with our advanced Metabolite Synthesis Services for Drug Discovery designed for preclinical and clinical R&D programs worldwide.
Elevating Modern Drug Discovery Through Specialized Metabolite Synthesis
Pharmaceutical and biopharma R&D teams rely on reliable Metabolite Synthesis Services for Drug Discovery to support metabolite identification, metabolic profiling, safety studies, and regulatory submissions. At ResolveMass Laboratories Inc., we specialize in delivering structurally confirmed, high-purity metabolites essential for ADME investigations, bioanalytical method development, and mechanistic toxicity assessments.
Our laboratory combines advanced synthetic chemistry, isotopic labeling capabilities, and mass spectrometry verification to help researchers overcome challenges associated with metabolite scarcity, instability, and regulatory timelines.
Optimize your development pipeline with precision chemistry: Explore our professional custom synthesis for drug discovery to secure high-quality chemical entities tailored to your specific research goals.
Why Metabolite Synthesis is Critical in Drug Discovery
Metabolites often play a decisive role in drug safety and efficacy. Generating authentic analytical standards enables:
- Improved metabolite identification
- Faster structure confirmation
- Higher confidence in toxicity risk assessments
- Streamlined preclinical reporting
- Data package support for IND/NDA filings
Key applications include:
- ADME & DMPK studies
- Bioanalytical quantitation
- Radiolabeled tracing
- Toxicology & mechanistic studies
- Regulatory compliance submissions
ResolveMass Laboratories Metabolite Synthesis Capabilities
Our experienced team of medicinal and synthetic chemists deliver metabolites across a wide range of chemical classes, stability profiles, and complexity including:
- Phase I metabolites (Oxidation, Reduction, Hydrolysis)
- Phase II metabolites (Conjugation: Glucuronides, Sulfates, Glutathione, etc.)
- Reactive intermediate analogs
- Isotopically labeled metabolites (¹³C, ²H, ¹⁵N)
- Stable & unstable metabolite forms
- Chiral and stereoselective metabolite variants
All synthesized metabolites undergo rigorous analytical characterization using NMR, LC-MS/MS, HRMS, and purity analysis to ensure traceability and reproducibility.
Achieve superior tracking in metabolic studies: Utilize our specialized isotopic labeling services to produce stable-labeled standards that deliver unmatched accuracy in your analytical assays.
End-to-End Service Workflow
1. Feasibility & Route Assessment
Route design, literature review, and initial synthetic strategy.
2. Synthesis & Optimization
Chemical synthesis and scale-up with iterative route refinement.
3. Characterization & Verification
Analytical confirmation with purity reporting and Certificate of Analysis (COA).
4. Delivery & Documentation
Shipment with complete regulatory support documentation.
Quality, Regulatory, and Documentation Compliance
ResolveMass Laboratories adheres to stringent quality and traceability standards to support regulatory filings globally. Comprehensive analytical documentation can be provided for use in GLP and IND-enabling studies, including:
- Certificate of Analysis (COA)
- Structural verification reports
- Stability profiles
- Purity documentation
- Analytical methods & chromatograms
Ensure the integrity of your pharmaceutical products: Learn more about our rigorous nitrosamine testing and analysis to identify and mitigate potential mutagenic impurities in your drug candidates.
Advanced Technologies Supporting Our Metabolite Services
Our platform integrates synthetic chemistry expertise with cutting-edge instrumental analytics including:
- LC-MS/MS & HR-MS metabolite confirmation
- NMR structural elucidation
- Chiral separation technologies
- Radiolabel incorporation
- Isotopic labeling workflows
This combination enables us to successfully deliver metabolites that are otherwise unobtainable from biological systems.
Streamline your impurity identification process: Discover our advanced impurity profiling using LCMS to gain deep insights into the molecular composition and safety of your compounds.
Who We Support
Our services are tailored for:
- Pharma & Biopharma R&D
- CROs & CDMOs
- Academic & Translational Research Labs
- Toxicology & DMPK Teams
- Bioanalytical Laboratories
Why Leading R&D Teams Choose ResolveMass Laboratories Inc.
- Scientific expertise demonstrated through successful metabolite challenges
- High success rates in complex metabolite routes
- Confidential, ISO-aligned laboratory processes
- Transparent pricing & predictable timelines
- Global project support for IND/NDA submissions
Request a Project Consultation
Discuss your metabolite synthesis needs with our chemistry specialists. Request Quote
Accelerate Your Research With Specialized Metabolite Synthesis
ResolveMass Laboratories Inc. streamlines preclinical research with high-quality Metabolite Synthesis Services for Drug Discovery, empowering scientists with reliable metabolite standards, regulatory-ready data packages, and faster analytical timelines.
Frequently Asked Questions
While identification (MetID) tells you what has formed, synthesis is required as soon as you need to know how much is present or how toxic it is. Teams typically initiate synthesis when a specific metabolite exceeds the 10% threshold of total drug-related exposure or when a metabolite is suspected of having pharmacological activity. Producing a synthetic standard is the transition point from qualitative observation to quantitative, regulatory-grade data collection.
A high-quality service provider must deliver a comprehensive Certificate of Analysis (CoA) that includes definitive proof of identity and purity. This typically involves $^{1}H$ and $^{13}C$ NMR spectroscopy for structural elucidation, along with High-Resolution Mass Spectrometry (HRMS) and HPLC data for purity verification. This level of documentation is vital for ensuring that the data generated using these standards will be accepted by global health authorities during the drug approval process.
During lead optimization, researchers use synthetic metabolites to understand the metabolic “soft spots” of a molecule—the specific areas where enzymes break the drug down too quickly. By synthesizing and testing these breakdown products, chemists can redesign the parent scaffold to block those sites, thereby improving the drug’s half-life and bioavailability. This iterative process of synthesis and testing is a cornerstone of transforming a promising “hit” into a robust clinical candidate.
Reference
- Wohlgemuth, R. (2023). Synthesis of metabolites and metabolite‑like compounds using biocatalytic systems. Metabolites, 13(10), 1097. https://doi.org/10.3390/metabo13101097
- Cerny, M. A., Kalgutkar, A. S., Obach, R. S., Sharma, R., Spracklin, D. K., & Walker, G. S. (2020). The effective application of metabolite profiling in drug design and discovery. Journal of Medicinal Chemistry, 63(12), 6387–6406. https://doi.org/10.1021/acs.jmedchem.9b01840