API Impurities

Trace amount of impurities may affect efficacy of the Active Pharmaceutical Ingredient (API). Even sometimes cause unwanted side-effects like- Therefore, their levels should be controlled and monitored. Guidelines and limits for several impurities are described in the respective pharmacopeia monographs.

Synthink Research Chemicals is a producer and supplier of number of pharmaceutical Impurities which are required for pharmaceutical companies to study quality, stability and biological safety of pharmaceutical products. Many API Impurities are available in our stock.

All Impurities / standards are provided with certificate of analysis (CoA) along with the comprehensive characterization data like 1H-NMR, MASS, HPLC Purity etc. On request, we also provide additional data like 13C-NMR, CHN, TGA, etc.

Click here to check sample CoA along with characterization data.

We are also manufacturer and supplier of several API Impurities listed in United States Pharmacopoeia(USP), European Pharmacopeia (EP), British Pharmacopoeia (BP), Japanese Pharmacopeia (JP), Indian Pharmacopeia (IP) pharmacopoeia, or unknown API impurities, Process Impurities, Degradation Impurities, API Related Compounds and Potential Impurities as per specification / requirement.

Synthink Research Chemicals is mainly active in custom synthesis / manufacturing of Pharmaceutical Impurities / Reference Standards (Pharmacopeial and non-Pharmacopeial), API Impurities as well as working standards which are required for pharmaceutical companies to study quality, stability and biological safety of pharmaceutical products.

In many cases required impurities found in a pharma product is required to custom synthesize / produce. In such cases clients need to send the details of the required product to SynThink.

At Synthink, we produce / make impurities using reliable scientific processes / techniques like organic synthesis techniques, enrichment and isolation by chromatography techniques, degradation and isolation process, etc.

Pharmaceutical (API / Drug) impurities produced by Synthink Research Chemicals can be used for monitoring acquiring and evaluating data that establishes quality, stability and biological safety of pharmaceutical products.

Pharmaceutical Impurities for ANDA / DMF filling

API impurities produced by Synthink Research Chemicals can be used for ANDA / DMF filling and genotoxicity studies.

Custom synthesis of Non Pharmacopeial Reference Standards / Working Standards

We are completely aware that impurities in pharma product is always a matter of worry within different departments of a pharmaceutical company. So, at SynThink we are committed to synthesize and characterize required Working Standards, Pharmacopeial and non-Pharmacopeial Reference Standards, API Impurities as well as other R&D Compounds in a timely manner. Please feel free to request a quote from us.