Custom Synthesis in CROs: Why Precision Matters in Impurity Standards
In regulated pharmaceutical development, every compound, especially impurities and metabolites, must be precisely identified, synthesized, and validated. Whether it's for ANDA filing, DMF submission, or bioanalytical testing, custom synthesis plays a critical role in ensuring that regulatory expectations are met with scientific accuracy.
As a specialized Contract Research Organization (CRO), Pharmaffiliates offers precision-driven custom synthesis services designed for pharmaceutical companies operating in tightly regulated global markets.
Why Custom Synthesis Is Essential in Modern Pharma
Standard reference materials aren’t always enough. Novel drug formulations, unknown degradation products, and regulatory queries often require custom-designed impurity or metabolite standards. In these cases, CROs step in to develop:
- Process impurities
- Degradation products
- Drug metabolites
- Intermediates
- Isotopically labelled compounds
- Stable isotope compoundsForced degradation byproducts
Each of these compounds needs to be synthesized with defined purity, reliable characterization, and full documentation (e.g., CoA, MSDS, NMR, HPLC, Mass, IR).
Pharmaffiliates: A Trusted CRO for Impurity Synthesis
At Pharmaffiliates, our synthesis team works closely with clients to deliver tailor-made reference standards with complete analytical data packages. We support:
- Impurity standards are not commercially available
- Regulatory submission batches for ANDA, DMF, or CTD
- Impurities required for stability or toxicological studies
- Bioanalytical reference compounds for BE/BA studies
Our processes follow ICH Q3A/B, Q1A, and other global guidelines, ensuring each synthesized compound is compliant and submission-ready.
Our Custom Synthesis Capabilities
Pharmaffiliates operates GMP-compliant synthesis labs equipped for:
- Milligram to multi-gram synthesis
- Process optimization for impurity reproducibility
- Isolation from API or finished dosage form
- Structural elucidation using NMR, LC-MS/MS, GC-MS
- Documentation including CoA, HPLC, MS, NMR, FTIR spectra
We also offer:
- Impurity route scouting
- Synthesis under isotopic labelling conditions
- Long-term supply options for commercial needs
Use Case: ANDA Submission with Custom Impurity Synthesis
A US-based client preparing an ANDA needed:
- Structural confirmation data for submission
- HPLC method development support
Pharmaffiliates delivered:
- Full analytical package (NMR, HPLC, LC-MS/MS, CoA)
- Stability data under ICH Q1B conditions
Talk to Our Synthesis Team for Impurity or Metabolite Requests
Whether you're missing a reference standard or need a custom synthesis route for an impurity, Pharmaffiliates is ready to help. Our synthesis experts collaborate with regulatory teams, formulators, and analytical scientists to ensure precision, purity, and documentation meet the highest global standards.
Get in touch to explore how we can support your next submission with tailor-made compounds.
Frequently Asked Questions
Q1. What is custom synthesis in CROs? Custom synthesis refers to the design and lab-scale production of unique chemical compounds, such as impurities or drug metabolites, that aren’t commercially available.
Q2. Why are impurity standards needed in regulatory filings? Regulatory authorities require detailed impurity profiles, often needing synthesized standards for method validation, stability testing, and toxicological assessments.
Q3. How does Pharmaffiliates ensure quality in custom synthesis? All compounds are synthesized in GMP-compliant labs, validated with NMR, HPLC, MS, and other analytical methods. Full CoA and supporting documentation are provided.
Q4. Can you synthesize stable isotope-labelled compounds? Yes. Pharmffiliates offers synthesis of isotope-labelled compounds on request, for use in pharmacokinetic and metabolite studies.
