Analytical Development

Syngene’s Analytical Services team helps analyze both small and large molecules using a variety of spectroscopic, chromatographic, and physiochemical techniques.
Enhancing drug quality using sophisticated analysis and testing

Syngene has a state-of-the-art infrastructure in synthetic organic chemistry and analytical laboratories at par with labs in the US/EU. These labs with modern instrumentation allow our scientists to perform high-quality services and deliver to our customers. Besides, Syngene-chemists have walk-in access to analytical instruments and individual access to chemical databases (Scifinder, Reaxys), which accelerates the problem solving and provide innovative solutions to our clients. We ensure high-quality delivery of our services by monitoring the KPIs/KQIs defined at the beginning of the collaboration.

Syngene’s Analytical Services team helps analyze both small and large molecules using a variety of spectroscopic, chromatographic, and physiochemical techniques, playing a vital role in the discovery and development processes of pharmaceuticals, fine chemicals, agrochemicals, oligonucleotides  and other products.

We offer comprehensive analytical solutions in strict compliance with good manufacturing practices (GMP), good laboratory practices (GLP), or other guidelines as required by clients. With separate labs for research-level studies and fully compliant GMP/GLP analytical work, the team supports clients’ research and development or custom synthesis projects and provides stand-alone services.

We provide comprehensive analytical solutions including method development, method transfer, method validation, characterization studies, in-process, lot release and stability analysis. We specialize in developing high-throughput analytical methods for mid and large-scale combi-chem library molecules. For process development or stability testing, we can support multiple approaches such as analytical methods development and in-house validation or developed methods transferred-in from the client and validated in-house or validated methods transferred-in from the client and verified through formal protocols.

In addition, we also offer expertise in micro-biology testing, semi-preparatory and preparatory purification, impurity isolation, structural elucidation and characterization.

Our analytical offerings include:

  • Method Development: We offer hands-on experience to develop and optimize stability indicating analytical methods using latest tools and techniques. Additionally, we offer method development with specialized instruments for GTI’s and nitrosamines.
  • Method Verification/Validation: We can support analytical method validation for Drug Substance and Drug Product (solid, semisolid, solutions and parenteral formulations) as per ICH Q2R1 guidelines.
  • Structural Characterization and Elucidation: We provide full spectrum of service offerings for compound characterization and structural elucidation of finished goods using MS, MS/MS, 1D, 2D NMR etc.
  • Reference & Working Standards Qualification: We can prepare working reference standards by selecting the highest purity material from different batches of the same product against the official reference standards. In case the official reference standards are not available, we qualify the material by subjecting it to additional purification
  • Identification & Characterization of Impurities: We can develop either a suitable method or adapt an existing method for impurity isolation and characterization. Isolation of the impurities are executed with preparatory HPLC by using detectors such as UV/ELSD/CAD/RI/GPC/MS or supercritical fluid preparatory chromatography followed by detailed structure elucidation using MS and NMR techniques.The results from impurity characterization studies can be presented as a formal report suitable for regulatory submissions. In addition, we can characterize and identify potential impurities and degradation products present in API.
  • Prep HPLC/Chiral Purification: We can support a broad and comprehensive range of preparative HPLC services. We offer isolation, purification and concentration of single components from crude samples or complex mixtures. We carry out high-throughput purification for small as well as large scale library molecules using mass-based auto-purification. We also have the capability for separation of multi gram quantity of chiral compounds using preparative SFC.
  • Residual Solvent Analysis: We can support Residual Solvent Analysis for manufacturing process to meet ICH limits. We develop methods for the analysis using GC (auto liquid injector) or GC (head space sampler).
  • Elemental Impurities analysis: We can support for elemental impurities (Class 1, 2A, 2B and 3) analysis as per ICH Q3D(R1) for drug substances, its various intermediates and raw materials.
  • Method Verifications/Transfer: We can transfer the validated methods between laboratories and sites to maintain their validated state and ensure the same reliable results in the receiving laboratory.
  • Stability Studies: We can support stability studies as per ICH Q1A guidelines for both drug substances and formulation doses. We can support for photostability testing as per ICH Q1B guideline for both drug substances and products. Additionally, we support for development & validation of analytical methods to cater stability requirements.
  • Phys-Chem Studies/5-Batch Analysis: We have capabilities to perform physical-chemical tests required as per regulatory requirements. We offer full services for 5-batch testing of agrochemical active ingredients to meet world-wide regulatory compliance. We can conduct more than 10 5-Batch analysis and method validation annually as per different regulatory requirements.