Phase I and II metabolite reference materials
Metabolites, oxidative cleavage products and glucuronide conjugates for bioanalytical method development, metabolite identification and stable-label tracing — supplied with structure confirmation suitable for LC-MS/MS workflows.
Phase I
oxidative
Phase II
glucuronides
≥95%
purity band
D7 / 13C
label options
MS/MS
fragments on COA
Metabolites in development vs GMP impurity control
Metabolite standards support PK/PD studies, reaction phenotyping and comparison to circulating analytes. They are distinct from process impurities but share the same need for unambiguous structure and stability data.
Glucuronides and other conjugates are often supplied as dry solids or buffered solutions with cold-chain guidance because hydrolysis back to parent can occur at neutral pH.
Common metabolite types
Phase I
- Hydroxylation and dealkylation products
- N-oxidation and deamination
- Acidic metabolites from β-oxidation or ring opening
Phase II
- Acyl and ether glucuronides
- Sulfates where synthesized
- Glutathione conjugates (often as toolbox standards)
Peptide / biologic metabolites
- Truncated circulating forms
- Deamidated or oxidized metabolites for LC-MS bioanalysis
Typical COA elements
Figures are indicative industry-typical values. Lot- and project-specific data appear on the quotation and certificate of analysis.
Structure
NMR + MS
Glucuronides may include selective 2D NMR
Purity
≥95–98%
HPLC or LC-UV
Diastereomers
Reported
Acyl glucuronides especially
Water / solvents
KF, Q3C
As per isolation route
Biological titer
Not applicable
Chemical reference only
Figures are indicative industry-typical values. Lot- and project-specific data appear on the quotation and certificate of analysis.
How teams use metabolite standards
Identify in incubates
Compare accurate mass and MS/MS to in silico predictions; prioritize quantitatively significant routes.
Source or synthesize
Obtain authentic standard for each tracked analyte; confirm no interference with parent MRM transitions.
Validate LC-MS/MS
Calibration in biological matrix with stable-isotope internal standard where available.
Bridge to clinic
Document metabolite coverage in IB/ISS; retain retain samples under ICH stability if required.
Deliverables
- Authenticated structure file and systematic name
- COA with assay and identity
- Recommended solubility and buffer for stock solutions
- Optional isotope-labeled pair for internal standard
- Custom synthesis proposal when metabolite not in catalogue
Frequently asked questions
Yes — custom synthesis with structure proof is the default for novel glucuronides and oxidative metabolites.
Related
Stable-Isotope Standards
Deuterated and 13C-labeled impurities, metabolites and APIs for isotope dilution quantitation — minimizing matrix suppression effects in bioanalysis and nitrosamine confirmatory methods.
View detailsCustom Impurity Synthesis
When catalogue search does not return your peak, we design a synthesis or isolation route for deletion peptides, genotoxic alerts, nitrosamines, metabolites and chiral variants — with a documented package for qualification.
View detailsPeptide Impurities
Deletion, truncation, oxidation and racemization variants isolated or synthesized to support peptide impurity qualification, method development and regulatory filing narratives under ICH Q3A/Q3B and peptide-specific expectations.
View detailsChiral Impurities
Enantiomers and diastereomers as traceable standards for chiral HPLC, chiral LC-MS and ICH Q6A/Q11-related impurity control — with stated enantiomeric or diastereomeric excess on the certificate of analysis.
View detailsReady to specify this for your program?
Share sequence, scale and documentation needs. We reply with indicative specs and a project-specific quotation.