Putting Science to Work

Stability Studies

Stability Studies

Syngene offers analytical services for both small and large molecules for discovery and development processes across pharmaceuticals, fine chemicals, agrochemicals and other products using a variety of spectroscopic, chromatographic and physiochemical techniques.

All the services can be provided as per GMP/ GLP compliant studies as per clients’ requirements. Syngene specializes in:

  • Developing high throughput analytical methods for mid and large-scale combi-chem library molecules
  • Semi-preparatory and preparatory purification, impurity isolation, structural elucidation and characterization

In addition, we can also support method development, method transfer, method validation, characterization studies, in-process, lot release and stability analysis. The work can be carried out in support of R&D or custom synthesis projects or as stand-alone services. There are separate labs for research-level analytical development/characterization and for fully-compliant GMP/GLP analytical work.

Analytical methods for product testing or stability testing can be developed and validated in-house or transferred in from the client and validated in-house. Validated methods can also be transferred in and verified through formal protocols.

  • method-development
    Method Development/Validation
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  • structural-elucidation
    Structural Elucidation
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  • RWSQ
    Reference & Working Standards Qualification
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  • Characterization_compounds
    Characterization of Compounds
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  • Identification_Characterization_Impurities
    Identification & Characterization of Impurities
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  • _45A8493_chiral
    Prep HPLC/Chiral Purification
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  • RSA
    Residual Solvent
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  • method-verification
    Method Verifications/Transfer
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  • stability_studies
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  • phys-chem-studies
    Phys-chem Studies/5 Batch Analysis
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