Impurities & Intermediates
Our Core Offerings
We supply a complete range of pharmaceutical impurities required for method development, validation, stability studies, and regulatory submissions, including:
- Organic & Inorganic Impurities
- Chiral Impurities & Enantiomers
- Genotoxic Impurities
- Degradation Products & By-Products
- Metabolites
- Volatile & Residual Impurities
- Isotopes
High-purity intermediates used as key building blocks in pharmaceutical synthesis. We also offer custom intermediates designed as per project-specific requirements.
Research-grade APIs and related compounds with controlled impurity levels for pre-clinical research, formulation development, and analytical studies.
Specialty Compounds We supply a variety of speciality molecules, including:
- Amino Acids
- Food Additives
- Coloring Agents
Catalytic & Process Residues
We specialize in developing a wide range of specialty compounds tailored for use in pharmaceutical research, drug discovery, and developmental programs. With deep expertise in custom synthesis, impurity profiling, and analytical characterization, we support global pharma and biotech companies in accelerating innovation.
The qualification of synthetic compounds is a critical step in ensuring the biological safety, purity, and efficacy of drug substances. By evaluating comprehensive data on each compound, we help identify the presence and behavior of impurities—an essential need in modern pharmaceutical R&D.
Leveraging advanced technologies and creative scientific approaches, we design optimized synthetic routes, develop cost-effective chemical processes, and deliver high-quality, research-grade compounds. Our collaborative approach and strong scientific foundation make us a reliable partner for research, scale-up, and product development.
We provide end-to-end support in impurity detection, characterization, and synthesis:
- Impurities
- Process impurities
- Genotoxic impurities
- Volatile impurities
- Organic & inorganic impurities
- Residual impurities
- Chiral impurities
- Enantiomers
- Isotopes
- Degradation compounds
- Bi-products
- Metabolites
- Catalytic residues
- Intermediates
- Major API impurities
- Active Pharmaceutical Ingredients (API)
- Primary & secondary working standards
- Amino acids
- Food additives
- Coloring agents
Each compound is synthesized with strict adherence to ICH guidelines, regulatory requirements, and industry best practices.
- Custom synthesis expertise with high complexity capabilities
- Accurate impurity profiling using advanced analytical methods
- Regulatory-compliant documentation (COA, MSDS, NMR, HPLC, GC)
- High-purity compounds for R&D, stability studies, and method validation
- Rapid turnaround time with reliable project management
- Collaborative problem-solving approach designed to accelerate drug development
What is impurity profiling in pharmaceuticals?
Impurity profiling is the process of detecting, identifying, and quantifying impurities in APIs and drug products. It ensures the compound meets safety, quality, and regulatory guidelines, including ICH Q3A/Q3B.
Why are impurities important in drug development?
Impurities, even at trace levels, may affect the safety, stability, and efficacy of a drug. Profiling them early reduces regulatory risk and ensures product quality throughout the development lifecycle.
Do you provide custom synthesis for rare impurities?
Yes. We specialize in synthesizing rare, complex, and reference-grade impurities, including chiral, genotoxic, degradation, and metabolite compounds.
Which analytical techniques do you use to detect impurities?
We use multiple advanced techniques, including:
- HPLC / UHPLC
- GC / GC-MS
- LC-MS/MS
- NMR
- ICP-MS
- FTIR
These ensure accurate identification and quantification.
Can you supply primary and secondary standards?
Yes. We produce primary and secondary working standards used for method development, calibration, and validation in pharmaceutical QC labs.
Do you follow ICH and regulatory guidelines?
Absolutely. All synthesis, characterization, and documentation comply with ICH, FDA, EU, and WHO guidelines.
What industries do you serve?
We cater to:
- Pharmaceutical companies
- Biotechnology firms
- Research laboratories
- CROs and CDMOs
- Academic and government institutions
Can you assist in API development?
Yes, we support API development through route design, process optimization, impurity studies, and analytical research.