Metabolites & Impurities for Pharmaceutical Research

Expert Synthesis Solutions (ESS) is a globally trusted partner for pharmaceutical R&D professionals offering a unique catalog of high-purity metabolites, process-related impurities, and degradation compounds. With a portfolio of over 150 speciality metabolites and impurities, including many exclusively manufactured and rare compounds, ESS enables advanced drug development and bioanalytical testing with unparalleled accuracy and reliability.

From chiral intermediates to stability-testing standards, all ESS compounds are synthesized in-house, empowering researchers to achieve precision in pharmacokinetic studies, impurity profiling, and quality control workflows.

Metabolites and Impurities for Pharmaceutical Research

ESS’s metabolites and impurities portfolio addresses critical needs in pharmaceutical research:

  • Drug Metabolites – Key for ADME (Absorption, Distribution, Metabolism, Excretion) studies and toxicity assessments.
  • Process-Related Impurities – Identified and quantified to meet ICH guidelines for drug safety.
  • Degradation Products – Critical for stability testing and shelf-life determination.
  • Stereoisomers & Enantiomers – High-purity standards for chiral separations and bioequivalence studies.

These compounds are indispensable for drug metabolism and pharmacokinetics (DMPK), impurity profiling, and regulatory submissions.

Highest Quality Metabolites and Impurities for R&D Applications

All ESS compounds are classified as R&D-grade and synthesized to prioritize structural accuracy, isotopic purity (where applicable), and batch-to-batch reproducibility. While ESS is not ISO certified, each metabolite and impurity undergoes in-house quality control protocols to ensure reliability. Advanced analytical techniques such as HPLC (for purity verification), NMR spectroscopy (structural confirmation), and mass spectrometry (molecular weight validation) are employed to validate every compound. 

A Certificate of Analysis (CoA) is available for each in-stock product, detailing purity levels, analytical methods, and spectral data (e.g., NMR, MS). Researchers can review and download CoAs directly from the ESS web store prior to purchase, ensuring full transparency and informed decision-making.

Key Applications in Pharmaceutical R&D

  • Bioanalytical Method Development: Metabolite quantification in plasma, urine, and tissue homogenates using LC-MS/MS.
  • Forced Degradation Studies: Identification of degradation pathways for ICH-compliant stability protocols.
  • Chiral Separations: Resolution of enantiomers for pharmacokinetic profiling (e.g., Warfarin isomers).
  • Impurity Mapping: Structural elucidation of synthetic by-products to meet regulatory filing requirements.

Featured Metabolites & Impurities

The company’s metabolites and impurities catalog includes a diverse selection of high-purity products, including:

Drug Metabolites

Ibrutinib Dihydrodiol
CAT#: ESS0344
 CAS #: 1226872-27-0, 1654820-87-7
 Purity: 98.8% by HPLC
 MF: C25H26N6O4  MW: 474.51
 Inventory status: IN STOCK
Application: Used to study CYP450-mediated metabolism in oncology drug development via LC-MS/MS plasma assays.

5A/6A-Hydroxy Lurasidone
CAT#: ESS0202
 CAS#: 186204-33-1
 Purity: 98.6% by HPLC
 MF: C28H36N4O3S     MW: 508.68
 Inventory status: IN STOCK
Application: Quantifies hydroxylated metabolites in antipsychotic drug permeability and CNS exposure studies.
5-O-Desmethyl Omeprazole Sulfide
CAT#: ESS0243
 CAS#: 103877-02-7
 Purity: 98.1% HPLC
 MF: C16H17N3O2S     MW: 315.39
 Inventory status: IN STOCK
Application: A key metabolite in omeprazole research, used to study sulfide derivatives in gastric acid suppression mechanisms.

Impurities

Safinamide Impurity 1 Mesylate
CAT#: ESS0466
 CAS#: 1000370-27-3 (free base)
 Purity: 99.7% by HPLC
 MF: C25H28F2N2O5S   MW: 506.56
 Inventory status: IN STOCK Application: Validates impurity thresholds in Parkinson’s disease therapeutics for ICH compliance.
Cisapride Impurity 7
CAT#: ESS0474
 CAS#: 86718-76-5
 Purity: 99.8% by HPLC (sum of axial and equatorial isomers)
 MF: C24H32ClFIN3O4   MW: 607.88
 Inventory status: IN STOCK Application: Essential for stability-indicating methods in gastrointestinal drug development.
rac threo-Dihydro Bupropion Hydrochloride
CAT#: ESS0232
 CAS#: 80478-42-8
 Purity: 100% by HPLC
 MF: C13H31Cl2NO     MW: 278.22
 Inventory status: IN STOCK Application: A process-related impurity for antidepressant formulations, used in forced degradation studies.

Degradation Compounds

34-Hydroxy Sirolimus
CAT#: ESS0312
 CAS#: 185107-79-3
 Purity: 96.2% by HPLC
 MF: C51H81NO14    MW: 932.19
 Inventory status: IN STOCK
Application: A major metabolite of sirolimus (rapamycin), used in immunosuppressive therapy research and LC-MS/MS quantification in plasma for therapeutic drug monitoring and metabolic pathway studies.
Oxybutynin-N-Substituted Allyl Impurity
CAT#: ESS0515
 CAS#: NA
 Purity: 98.6% by HPLC
 MF: C38H49NO6   MW: 615.80
 Inventory status: IN STOCK
 Application: A process-related impurity in overactive bladder therapeutics, used in stability-indicating method validation and forced degradation studies to ensure drug formulation compliance.


PET Cyclic Trimer
CAT#: ESS0320
 CAS#: 7441-32-9
 Purity: 99.3% by HPLC
 MF: C30H24O12      MW: 576.51
 Inventory status: IN STOCK
Application: A polyester degradation product, employed in analytical testing for polymer-based drug delivery systems to validate impurity thresholds and material stability under stress conditions.

Stereochemical Standards

S-(-)-Warfarin
CAT#: ESS0349
 CAS#: 5543-57-7
 Purity: 100% by HPLC; 99.9% ee
 MF: C19H18O4     MW: 308.33
 Inventory status: IN STOCK Application: A chiral reference standard for anticoagulant drug development, enabling precise resolution of enantiomers in pharmacokinetic studies and bioequivalence testing.
R-(+)-Warfarin
CAT#: ESS0348
 CAS#: 5543-58-8
 Purity: 100% by HPLC; 100% ee
 MF: C19H16O4    MW: 308.33
 Inventory status: IN STOCK
 Application: The enantiomeric counterpart to S-(-)-Warfarin, used in anticoagulant research and enantiomer resolution for bioequivalence studies.


rac erythro-Dihydro Bupropion Hydrochloride
CAT#: ESS0233
 CAS#: 80478-43-9
 Purity: 99.9% by HPLC
 MF: C13H21Cl2NO     MW: 278.22
Application: A diastereomeric impurity of bupropion, critical for studying metabolic pathways and chiral separations in antidepressant formulations.

Cost-Effective Metabolites and Impurities with Global Availability

ESS provides highly cost-effective R&D-grade metabolites and impurities, delivering exceptional quality and reliability at competitive prices. The full inventory of in-stock compounds is available for immediate purchase through the ESS online store.

By eliminating ISO-certification overhead costs while maintaining the highest purity and performance standards, ESS is a stand-out partner particularly when using compounds strictly for R&D applications. As every in-stock compound is supplied with a CofA containing detailed analytical data, clients can opt to certify compounds in-house if required. In-stock items ship globally via secure logistics.

By combining quality, accessibility, transparent practices, and cost-effective options, ESS equips researchers with metabolites and impurities for fast and precise workflows with compliance readiness when required.

Why Choose Expert Synthesis Solutions?

✔ High-purity R&D-grade metabolites and impurities
✔ Catalog of more than 150 metabolites and impurities
✔ Exclusively manufactured and rare metabolites and impurities
✔ All synthesized in-house for guaranteed quality and consistency
✔ Certificate of Analysis (CofA) for every in-stock product
✔ Cost-effective R&D metabolites and impurities
✔ No ISO overhead ensuring competitive pricing
✔ Easy Client-driven ISO certification options
✔ Ready-to-ship availability
✔ Global delivery via a secure supply chain

For more information and to explore the full catalog, visit ESS Metabolites & Impurities.

Expert Synthesis Solutions continues to support pharmaceutical research with precision, reliability, and affordability in metabolite and impurity standards.


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