Custom synthesis of rare impurities
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.
mg–100 g
scale range
4–12 wk
typical timeline
Structure
proof mandatory
GMP
optional track
COA
full analytical
When custom synthesis is the right path
Unknown LC peak, patent-protected intermediate, or NDSRI that cannot be purchased requires a dedicated route. Scope includes literature search, retro-synthesis and feasibility on milligram scale before scale-up.
Deliverables align with your intended use: R&D spiking, qualification or GMP reference standard manufacture.
Project phases
Intake
Structure (drawn or inferred from MS), required purity, quantity and regulatory use.
Route selection
Prioritize shortest path with orthogonal analytical proof; flag genotoxic reagents.
Pilot and characterize
mg batch with full structure elucidation before committing to larger scale.
Scale and release
Purify to agreed purity; issue COA and optional stability study.
Typical deliverables
- Defined quantity with lot number
- COA: identity, purity, water, residuals
- Structural report (NMR, HRMS)
- Project summary for CMC section cross-reference
- Retain sample for your stability programme
Indicative timeline
Weeks 1–2
Manufacturing
Route scouting, mg pilot
Analytics
LC-MS confirmation of target
Regulatory
Quote and quality agreement
Weeks 3–8
Manufacturing
Scale-up and purification
Analytics
Full characterization
Regulatory
Change control if GMP
Weeks 9+
Manufacturing
Optional GMP batch
Analytics
Stability initiation
Regulatory
Support for impurity qualification report
Frequently asked questions
Parent drug name, impurity structure or MS data, required amount, purity target and whether GMP is needed.
Related
Peptide 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 detailsNitrosamine Impurities
Small-molecule nitrosamines and nitrosamine drug substance-related impurities (NDSRIs) as reference materials for confirmatory testing, CPCA categorization and acceptable intake (AI) justification under current FDA, EMA and ICH M7 expectations.
View detailsCertified Reference Materials
Impurities and API-related CRMs with certified property values, measurement uncertainty and metrological traceability — produced or distributed under principles aligned with ISO 17034 for method validation and lab accreditation.
View detailsOncology Reference Standards
Impurities, degradants and reference standards for cytotoxic and targeted oncology APIs — supporting potency assays, related-substances control and nitrosamine risk assessment in high-potency handling environments.
View detailsReady to specify this for your program?
Share sequence, scale and documentation needs. We reply with indicative specs and a project-specific quotation.