NABL CDSCO USFDA Inspected — Manesar & Bangalore ICH Q6A

Solid State Characterization | XRD DSC TGA FTIR | NABL Accredited | Auriga Research

Complete in-house solid-state package — Powder XRD at Baddi, DSC and TGA at Manesar (USFDA Inspected), FTIR at Delhi, Baddi and Bangalore. ICH Q6A compliant reporting for CTD Module 3.

In-House Solid-State Platforms — All NABL Accredited

  • · Powder XRD (PXRD) — Baddi
  • · DSC (Differential Scanning Calorimetry) — Manesar (USFDA Inspected)
  • · TGA (Thermogravimetric Analysis) — Manesar (USFDA Inspected)
  • · FTIR — Delhi, Baddi, Bangalore (3 labs)
  • DVS (Dynamic Vapour Sorption) hygroscopicity profiling and Raman spectroscopy are NOT in-house — available via validated partner laboratory on request (contact SPOC at quote stage).

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 a complete in-house solid-state package combining Powder XRD at Baddi, DSC and TGA at our USFDA Inspected Manesar facility, and FTIR at three labs (Delhi, Baddi, Bangalore) to deliver the full ICH Q6A solid-state profile required for drug development decisions and CTD Module 3 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 Powder XRD fingerprinting, DSC thermal analysis, TGA for solvate and hydrate assessment, and FTIR spectroscopy for molecular conformation analysis. We determine thermodynamic relationships between polymorphs, identify the most stable form and assess conversion risks during processing and storage — all under NABL ISO/IEC 17025:2017 accreditation.

Beyond polymorphism, our solid-state capabilities include amorphous content quantification by XRD and modulated DSC (mDSC), salt and co-crystal screening, solid-state stability assessment under stressed temperature and humidity, and CTD Module 3.2.S.3.1 (Elucidation of Structure) and 3.2.S.3.3 (Physicochemical Properties) dossier compilation. Where DVS hygroscopicity or Raman data is required, we route through a validated partner laboratory on request and disclose the partner channel openly — never represented as in-house under Auriga NABL scope.

Solid-State Characterization Services

Each service mapped to its in-house technique and lab location for quick CTD Module 3 scoping.

PXRD

Powder XRD (PXRD) at Baddi

Powder X-Ray Diffraction per ICH Q6A — polymorph fingerprinting, amorphous content quantification and crystal-form identification at our Baddi lab.

DSC

DSC at Manesar

Differential Scanning Calorimetry per USP and ICH Q6A — melting point, glass transition and polymorphic transitions at our USFDA Inspected Manesar lab.

TGA

TGA at Manesar

Thermogravimetric Analysis for thermal stability, solvate and hydrate stoichiometry, and residual solvent screening at our Manesar lab.

FTIR

FTIR — 3 Labs

FTIR spectroscopy for solid-state identity and polymorphic form confirmation at Delhi, Baddi and Bangalore — three-lab capacity for parallel runs.

Polymorph

Crystal Form Screening & Polymorph Selection

Systematic crystallisation from diverse solvent systems, temperatures and conditions — full polymorph mapping with stable-form selection per ICH Q6A.

Stability

Solid-State Stability Assessment

Accelerated solid-state stability under stressed temperature and humidity — flags form conversion, hydrate transitions and amorphous collapse risks.

Hygroscopicity profiling by DVS available on request — contact SPOC. DVS (Dynamic Vapour Sorption) and Raman spectroscopy are not performed in-house at Auriga; where required, both are arranged through a validated partner laboratory and supplied as accompanying documentation alongside our in-house NABL data.

How It Works — 4 Steps to Your NABL Solid-State Report

1

Get a Quote

Share compound, development stage and characterisation question — polymorph screening, compatibility or full solid-state package. Your SPOC confirms techniques and sample requirement.

2

Collect and Send Your Sample

Prepare per SPOC instructions at quote stage. Each sample is bar-coded and registered in YLIMS on receipt with full chain-of-custody.

3

Testing and QA Review

Tested under NABL-accredited conditions across XRD (Baddi), DSC/TGA (Manesar) and FTIR (Delhi/Baddi/Bangalore). Results pass through formal QA review before release.

4

Receive Your NABL Report

NABL report delivered digitally within committed TAT, formatted for CDSCO, USFDA and regulatory submission. Track every technique via YLIMS.

Project Timelines

Package Turnaround Time
Individual Technique (XRD, DSC, TGA or FTIR alone) 5-7 business days
Basic Package (XRD + DSC + TGA) 7-10 business days
Full Solid-State Package (XRD + DSC + TGA + FTIR) 10-14 business days
Polymorphism Screening Programme 4-8 weeks
Comprehensive Solid-State Study (with stability) 6-12 weeks

Who Needs Solid-State Characterization

  • ✓ Pharma formulators selecting optimal crystal form during API development
  • ✓ Generic manufacturers requiring polymorph data for CDSCO or USFDA dossier submission
  • ✓ CDMO clients needing solid-state package as part of formulation development and tech transfer
  • ✓ Stability teams monitoring solid-state changes during ICH Q1A(R2) accelerated and long-term stability
  • ✓ Innovator pharma compiling ICH Q6A specifications for new drug substance approval
  • ✓ Patent and IP teams identifying novel polymorphic forms and salt/co-crystal candidates
  • ✓ API manufacturers documenting polymorphic-form consistency batch-to-batch for DMF filings
  • ✓ Regulatory affairs teams compiling CTD Module 3.2.S.3.1 (Elucidation of Structure) packages

Why Auriga for Solid-State Characterization

XRD + DSC + TGA + FTIR — All In-House

XRD at Baddi, DSC at Manesar, TGA at Manesar, FTIR at three labs (Delhi, Baddi, Bangalore) — complete solid-state characterisation in one organisation with one SPOC and one NABL report.

No Instrument Dependency Delays

All four solid-state platforms are operated in-house — no waiting on third-party labs for cross-technique correlation. Same QA team reviews XRD, DSC, TGA and FTIR data side-by-side.

ICH Q6A Compliant Packages

Reports formatted for direct submission into CTD Module 3.2.S.3.1 (Elucidation of Structure) and 3.2.S.3.3 (Physicochemical Properties) for CDSCO, USFDA and EMA dossiers.

USFDA Inspected — Manesar & Bangalore

DSC and TGA at Manesar (USFDA Inspected, IMT Plot 136 Sector 5) and FTIR at Bangalore (USFDA Inspected, WHO Prequalified) — solid-state data accepted in ANDA filings.

Honest Scope on DVS and Raman

Where DVS hygroscopicity or Raman is required, we disclose partner-lab routing up-front and arrange a validated partner channel — no hidden hand-offs or surprise data caveats.

Bar-Coded YLIMS Chain of Custody

Every sample bar-coded and registered in YLIMS on receipt — single audit trail spans XRD at Baddi, DSC/TGA at Manesar and FTIR at Delhi/Baddi/Bangalore.

5+

NABL Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group Established

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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 and thermal behaviour. These properties directly affect drug stability, solubility, bioavailability and manufacturability, making solid-state data essential for ICH Q6A compliance and regulatory submissions in CTD Module 3.
What techniques does Auriga use for solid-state characterization?
Auriga delivers a complete in-house solid-state package combining four complementary techniques: Powder XRD (PXRD) for crystal structure and polymorph identification at our Baddi facility, DSC (Differential Scanning Calorimetry) for thermal transitions and melting behaviour at Manesar, TGA (Thermogravimetric Analysis) for thermal stability and solvate characterisation at Manesar, and FTIR spectroscopy for molecular conformation analysis at three labs (Delhi, Baddi, Bangalore). Together these techniques satisfy ICH Q6A solid-state requirements without external instrument dependencies.
Does Auriga perform DVS (Dynamic Vapour Sorption) and Raman spectroscopy in-house?
No. DVS hygroscopicity profiling and Raman spectroscopy are NOT performed in-house at Auriga Research. Where these techniques are required as part of a solid-state package, Auriga can arrange them through a validated partner laboratory on request — please contact your SPOC at quote stage. All in-house techniques (XRD, DSC, TGA, FTIR) are delivered under NABL ISO/IEC 17025:2017 accreditation; partner data is supplied as accompanying documentation rather than under Auriga NABL scope.
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. ICH Q6A and CDSCO, USFDA and EMA 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. The full solid-state package (XRD + DSC + TGA + FTIR) is delivered within 10-14 business days. Comprehensive polymorphism screening programmes with multiple crystallisation conditions require 4-8 weeks. Individual techniques (XRD, DSC, TGA or FTIR 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 across ICH Q6A specifications and 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. USFDA, 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 XRD + DSC + TGA + FTIR all in-house. ICH Q6A compliant data packages formatted for CTD Module 3 regulatory submissions across CDSCO, USFDA and EMA.

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