NABL Accredited · Solid State Analysis Centre

Solid State Characterization Laboratory India | Polymorphism Testing | NABL

Comprehensive solid state characterization and polymorphism screening from an NABL-accredited pharmaceutical laboratory in India.

Solid state characterization is fundamental to pharmaceutical drug development — the physical form of an API determines its solubility, stability, bioavailability, and processability. Auriga Research provides comprehensive solid-state analysis services combining XRD, DSC, TGA, spectroscopy, and physical property testing to deliver the complete solid-state profile required for drug development decisions and regulatory submissions.

Our polymorphism screening programmes employ systematic crystallisation from diverse solvent systems, temperatures, and conditions to identify all accessible crystalline forms of your API. Each form is characterised by XRD fingerprinting, DSC thermal analysis, TGA for solvate assessment, and FTIR spectroscopy for molecular conformation confirmation. We determine thermodynamic relationships between polymorphs, identify the most stable form, and assess conversion risks during processing and storage.

Beyond polymorphism, our solid-state capabilities include amorphous content quantification, salt and co-crystal screening, hygroscopicity profiling by DVS, particle morphology assessment, and accelerated solid-state stability studies. All data is compiled into comprehensive reports suitable for inclusion in CTD Module 3 regulatory dossiers across FDA, EMA, CDSCO, and other regulatory markets.

Solid State Characterization Capabilities

  • Polymorphism screening from diverse crystallisation conditions
  • XRD fingerprinting for polymorphic form identification and batch consistency
  • DSC thermal analysis for melting, glass transition, and polymorphic transitions
  • TGA for thermal stability, solvate/hydrate characterisation, and residual solvents
  • FTIR and Raman spectroscopy for molecular conformation analysis
  • Dynamic Vapour Sorption (DVS) for hygroscopicity profiling
  • Amorphous content quantification by XRD and mDSC
  • Salt and co-crystal screening programmes
  • Accelerated solid-state stability studies under stressed conditions

Turnaround Time

Basic Package (XRD+DSC+TGA): 7-10 business days
Polymorphism Screening: 4-8 weeks
Individual Technique: 5-7 business days
Comprehensive Solid-State Study: 6-12 weeks

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Frequently Asked Questions — Solid State Characterization

What is solid state characterization in pharmaceutical development?
Solid state characterization is the comprehensive analysis of the physical properties of drug substances in their solid form. It encompasses polymorphism screening (identifying all crystalline forms), crystal structure determination, amorphous content quantification, solvate and hydrate identification, particle morphology, hygroscopicity, and thermal behaviour. These properties directly affect drug stability, solubility, bioavailability, and manufacturability, making solid-state data essential for drug development and regulatory submissions.
What techniques are used for solid state characterization?
A comprehensive solid state characterization programme employs multiple complementary techniques: XRD (X-Ray Diffraction) for crystal structure and polymorph identification, DSC (Differential Scanning Calorimetry) for thermal transitions and melting behaviour, TGA (Thermogravimetric Analysis) for thermal stability and solvate characterisation, FTIR and Raman spectroscopy for molecular conformation, DVS (Dynamic Vapour Sorption) for hygroscopicity, and microscopy for particle morphology. The combination provides a complete solid-state profile.
Why is polymorphism screening important for pharmaceutical APIs?
Polymorphism screening identifies all crystalline forms an API can adopt. Different polymorphs can have different solubility, dissolution rates, stability, and bioavailability — potentially affecting drug product performance and patient safety. Regulatory agencies require evidence that the intended polymorphic form is consistently produced and maintained throughout shelf life. Polymorphism screening also supports patent strategy by identifying novel forms that may be patentable.
What is the turnaround time for solid state characterization?
A basic solid state characterization package (XRD + DSC + TGA) at Auriga Research is completed within 7-10 business days. Comprehensive polymorphism screening programmes with multiple crystallisation conditions require 4-8 weeks. Individual techniques (XRD, DSC, or TGA alone) are completed within 5-7 business days with rush options available.
What regulatory submissions require solid state characterization data?
Solid state characterization data is required in CTD Module 3 (Quality) for ANDA, NDA, and MAA submissions. Specifically, Section 3.2.S.3.1 (Elucidation of Structure) requires XRD, DSC, and spectroscopic data; Section 3.2.S.3.3 (Physicochemical Properties) requires polymorphic form data; and Section 3.2.S.7 (Stability) may reference solid-state changes. FDA, EMA, CDSCO, and other regulatory agencies all require comprehensive solid-state data for drug substance characterisation.

Need Solid State Characterization for Your Drug Substance?

NABL-accredited polymorphism screening and comprehensive solid-state analysis. Complete CTD Module 3 data packages for regulatory submissions.

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