Spectrasynth Pharmachem Pvt. Ltd. is a GMP and ISO 9001:2015 certified manufacturer and supplier of pharmaceutical impurity reference standards, certified reference standards, active pharmaceutical ingredients (APIs), metabolites, chiral compounds, stable isotopes and nitrosamine impurities. We provide custom synthesis and impurity profiling services to pharmaceutical companies worldwide, with global shipping from our facility in Ahmedabad, India.
Certified pharmaceutical impurity reference standards with CAS numbers, product codes and custom synthesis across a wide range of parent APIs.
High-purity active pharmaceutical ingredients and metabolites synthesised and characterised to support formulation development and regulatory submission.
Nitrosamine impurity reference standards for risk assessment, mitigation and analytical method development in line with ICH and FDA guidance.
Advanced pharmaceutical intermediates for process development, scale-up and custom synthesis programmes.
Specialty and research chemicals, chiral compounds and stable isotope-labelled standards for analytical and R&D applications.
Custom molecule synthesis, impurity characterisation, process development and analytical method development for pharmaceutical companies worldwide.
With in-house synthesis capabilities and a dedicated research and development team, Spectrasynth delivers high-purity, fully characterised reference standards backed by certificates of analysis and ICH/FDA-aligned documentation. Our impurity profiling, nitrosamine risk assessment and process-development services support drug development from early research through to regulatory submission.
We manufacture and supply certified pharmaceutical impurity reference standards, active pharmaceutical ingredients (APIs), metabolites, chiral compounds, stable isotopes and nitrosamine impurities, together with custom synthesis and impurity profiling services.
Yes. Spectrasynth Pharmachem is a GMP and ISO 9001:2015 certified pharmaceutical manufacturer based in Ahmedabad, Gujarat, India, serving customers across the US, Europe and Asia.
Yes. We offer custom synthesis of impurity reference standards, including fully characterised compounds with CAS numbers, certificates of analysis (COA) and documentation aligned with ICH and FDA requirements.
Browse our impurity catalogue and enquire for any product, or contact us directly for pricing, COA, minimum order quantities, lead times and global shipping.