How much API is typically required for a full screening program?

Our high-throughput platforms are designed for minimal material consumption. A comprehensive polymorph, salt, or cocrystal screen can often be performed with 100–500 mg of API, depending on scope. Specific requirements are confirmed during the study design phase.

Can you screen for both salts and co-crystals in the same project?

Yes. We routinely combine salt and cocrystal screening in parallel using separate counterion and coformer panels. The same analytical readout (XRPD, DSC) is applied to both, and the results are integrated into a unified form recommendation.

How do you ensure that the characterized solid form is the most stable one?

We perform competitive slurry experiments in multiple solvents at controlled temperatures to establish thermodynamic stability relationships. Forms that convert under slurry conditions are ranked accordingly. This data, combined with thermal analysis, identifies the most robust form for development.

What analytical techniques are included in your standard characterization package?

Our standard package includes XRPD, DSC, TGA, and FTIR. Additional techniques such as Raman spectroscopy, ssNMR, and dynamic vapor sorption (DVS) can be added as needed. Each technique is selected to provide complementary information on crystallinity, chemical structure, and physical stability.

Do you provide support for amorphous form assessment?

We can assess the amorphous form of your API including glass transition temperature (Tg) measurement, physical stability (recrystallization tendency), and hygroscopicity. Amorphous solid dispersion formulation is a separate service; we can coordinate the transition to our formulation team if needed.

How are the results delivered and can they be used for regulatory submissions?

Results are compiled in a comprehensive technical report that includes raw data, method descriptions, and an interpretive discussion. The format is designed to directly support CMC sections of IND/NDA filings. We can also provide DMF-quality reports upon request.

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Solid-State Characterization

We deliver rigorous solid-form identification and physicochemical profiling to support your IND/NDA filings and formulation decisions.

High-throughput polymorph, salt, and co-crystal screening using minimal API
State-of-the-art analytical suite — XRPD, DSC, TGA, FTIR, Raman, ssNMR
Crystallization process development designed for scalable manufacturing
Regulatory-grade reports with complete data packages for submissions

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Why invest in solid-state characterization?

Solid-state characterization refers to the systematic identification and analysis of the physical forms of a drug substance — including polymorphs, salts, co-crystals, and amorphous phases. These solid forms can differ dramatically in solubility, dissolution rate, chemical stability, and mechanical properties, all of which directly impact bioavailability and manufacturability.

Regulatory agencies expect thorough characterization of all relevant solid forms early in development to ensure that the selected form remains stable throughout manufacturing and storage. Our service provides the data needed to make informed form selection decisions, de-risking subsequent formulation and scale-up activities.

Identify the optimal crystalline or amorphous form for your molecule
Prevent costly late-stage polymorph surprises
Generate robust data to satisfy regulatory expectations
Align form selection with downstream formulation and scale-up

Regulatory

Reproducible

Comprehensive

Our Approach

Integrated Solid-Form Discovery and Characterization

We combine high- and medium-throughput screening with orthogonal analytical techniques to systematically identify, characterize, and optimize the most suitable solid form for your drug candidate.

Systematic Solid Form Screening

Our team performs targeted polymorph, salt, and co-crystal screening using proprietary high-throughput platforms. We design experiments based on your molecule's physicochemical properties to maximize hit discovery with minimal material consumption.

High-throughput polymorph screening (solvent, temperature, anti-solvent, slurrying)
Salt and co-crystal screening with rational counterion selection
Conglomerate and diastereomeric salt screening for chiral resolution

Comprehensive Analytical Characterization

Every solid form candidate is fully characterized using a suite of orthogonal techniques to confirm identity, crystallinity, purity, and stability. This data forms the foundation for form selection and regulatory documentation.

XRPD for phase identification and crystallinity assessment
DSC/TGA for thermal behavior (melting, decomposition, glass transition)
FTIR, Raman, and ssNMR for molecular-level structural insight

Quality-Driven Data

All data are generated under controlled protocols with internal QA review. Reports include raw data overlays, method details, and interpretive summaries suitable for submission.

Statistical and Thermodynamic Rigor

We apply phase-diagram analysis and competitive slurry experiments to evaluate thermodynamic relationships and identify the most stable form under relevant conditions.

Formulation-Oriented Interpretation

Our solid-state experts translate analytical findings into actionable recommendations for formulation development, helping you select the form that best balances bioavailability, stability, and manufacturability.

Deliverables

What You Receive

A complete data package that enables confident form selection and supports regulatory submissions and formulation guidance.

Data Deliverables

XRPD diffractograms with peak lists and automated phase matching
DSC and TGA thermograms with onset/decomposition temperatures
FTIR/Raman spectra with assignment tables
Hygroscopicity and stability data (stress conditions, competitive slurries)
Crystallization process parameter summary

Reporting & Support

Comprehensive technical report with methods, results, and discussion
Form comparison matrix (stability, solubility, manufacturability)
Recommendation for optimal form and next development steps
Direct access to project lead for follow-up clarification

Service Scope

Project-Specific Parameterization

Each program is scoped individually based on your molecule's properties, development phase, and regulatory needs. Below are typical parameters addressed during consultation.

Parameter	Typical Project Scope
Polymorph Screening	High-throughput (up to 1000+ experiments) using solvent, temperature, anti-solvent, and slurry methods; form map and thermodynamic ranking
Salt Screening	Counterion selection panel of 20–50 pharmaceutically acceptable acids/bases; XRPD and DSC readout
Co-crystal Screening	Rational coformer selection based on H-bond donors/acceptors; high-throughput slurry and evaporation methods
Analytical Techniques	XRPD, DSC, TGA, FTIR, Raman, ssNMR, polarized light microscopy; additional techniques on request
Hygroscopicity & Stability	The stability profile of each solid form is evaluated using DVS (dynamic vapor sorption), accelerated stability studies (e.g., 40°C/ performance scoped per project RH, 60°C), and competitive slurry experiments to assess phase purity and transformation risk over time.
Crystallization Development	Seed optimization, cooling/anti-solvent/evaporative crystallization, yield and purity profiling, scale-up parameters
Amorphous Form Assessment	Amorphous form characterization includes glass transition temperature (Tg) measurement, physical stability monitoring (recrystallization tendency), and hygroscopicity assessment.
Chiral Resolution Screening	Conglomerate and diastereomeric salt screening; combination with racemization for high-yield resolution

Workflow

From Sample to Optimal Form in Five Steps

Our phased approach ensures thorough exploration of the solid-form landscape while maintaining alignment with your project timelines and drug substance limitations.

1. Sample Receipt & Study Design

We review your API's physicochemical properties and development goals to define the screening scope (polymorph, salt, co-crystal). A study plan is prepared and approved before any experiments begin.

2. High-Throughput Screening

Automated platforms perform hundreds of crystallization experiments under diverse conditions (solvent, temperature, anti-solvent, pH). Hits are identified by XRPD or Raman primary screening, and confirmatory XRD is run on unique forms.

3. Solid-State Characterization

Each distinct solid form is fully characterized by DSC, TGA, FTIR, Raman, and ssNMR as needed. Hygroscopicity and stability are assessed under controlled conditions to evaluate form robustness.

4. Data Analysis & Form Selection

All data are integrated into a form comparison matrix. Thermodynamic stability relationships are established via competitive slurry experiments. Together with the client, the optimal form for development is selected.

5. Crystallization Development & Reporting

For the chosen form, we design and optimize a scalable crystallization process, documenting yield, purity, and critical process parameters. A final comprehensive report with raw data and interpretive summary is delivered.

Applications

Supporting Your Development Pipeline

Our solid-state characterization services are applied across multiple stages of drug development, from early discovery through late-phase CMC support.

Identify the Most Promising Solid Form for Preclinical Development

In early discovery, limited material and time necessitate efficient screening. Our high-throughput platforms use only a few grams of API to map the polymorph, salt, and co-crystal landscape, enabling rapid form selection for in vivo studies.

Minimal API consumption (10–100 mg per screen)
Rapid turnaround of form rank and initial physical properties
Seamless transition to preformulation and formulation development

Generate Robust CMC Data for IND/NDA Submissions

Regulatory agencies require thorough characterization of solid forms, including polymorph purity, phase transitions, and stability. Our reports are organized to directly support Module 3 sections, with validated methods and raw data.

Complete analytical method descriptions and validation data
Stability studies under ICH conditions for polymorph monitoring
Phase purity and transformation risk assessment

Develop a Scalable, Reproducible Crystallization Process

Transitioning from milligram screening to kilogram manufacturing demands robust crystallization design. We optimize parameters (cooling, anti-solvent, seeding) to consistently deliver the target form with high yield and purity.

Seed point determination and temperature cycling studies
Process parameter robustness testing
Documentation of critical process parameters for tech transfer

FAQs

Common Questions About Solid-State Characterization

We address the most frequent concerns we hear from analytical development and regulatory teams when planning solid-form studies.

Our high-throughput platforms are designed for minimal material consumption. A comprehensive polymorph, salt, or cocrystal screen can often be performed with 100–500 mg of API, depending on scope. Specific requirements are confirmed during the study design phase.
Yes. We routinely combine salt and cocrystal screening in parallel using separate counterion and coformer panels. The same analytical readout (XRPD, DSC) is applied to both, and the results are integrated into a unified form recommendation.
We perform competitive slurry experiments in multiple solvents at controlled temperatures to establish thermodynamic stability relationships. Forms that convert under slurry conditions are ranked accordingly. This data, combined with thermal analysis, identifies the most robust form for development.
Our standard package includes XRPD, DSC, TGA, and FTIR. Additional techniques such as Raman spectroscopy, ssNMR, and dynamic vapor sorption (DVS) can be added as needed. Each technique is selected to provide complementary information on crystallinity, chemical structure, and physical stability.
We can assess the amorphous form of your API including glass transition temperature (Tg) measurement, physical stability (recrystallization tendency), and hygroscopicity. Amorphous solid dispersion formulation is a separate service; we can coordinate the transition to our formulation team if needed.
Results are compiled in a comprehensive technical report that includes raw data, method descriptions, and an interpretive discussion. The format is designed to directly support CMC sections of IND/NDA filings. We can also provide DMF-quality reports upon request.

Scientific Literature

References

Abbinante VM, Zampieri M, Barreca G, et al. Preparation and Solid-State Characterization of Eltrombopag Crystal Phases. Molecules (Basel, Switzerland). 2020;26(1). View on PubMed
Chen Y, Mutukuri TT, Wilson NE, et al. Pharmaceutical protein solids: Drying technology, solid-state characterization and stability. Advanced drug delivery reviews. 2021;172:211-233. View on PubMed
Oh DW, Chon J, Kang JH, et al. Physicochemical characterization of dapagliflozin and its solid-state behavior in stress stability test. Drug development and industrial pharmacy. 2021;47(5):685-693. View on PubMed
Adhikari BR, Gordon KC, Das SC. Solid state of inhalable high dose powders. Advanced drug delivery reviews. 2022;189:114468. View on PubMed
Bugay DE. Characterization of the solid-state: spectroscopic techniques. Advanced drug delivery reviews. 2001;48(1):43-65. View on PubMed

Please kindly note that our products and services are for research use only.