Solid State Chemistry Research
Solid-state chemistry research is a critical component of pharmaceutical CMC development, directly impacting drug stability, solubility, and bioavailability. ChemExpress' pharmaceutical solid-state chemistry research platform specializes in small molecule drug research, delivering end-to-end technical support from polymorph/salt form screening and crystallization process development through to commercial production. Having successfully served pharmaceutical companies worldwide, the platform helps clients achieve key milestones in drug development and accelerate regulatory submissions.
Our Service
- Solid State Analysis
- PLM (Polarized Light Microscopy) / PSD (Particle Size Distribution) analysis
- Analysis of polymorphic forms
- Solubility determination
- Stability study
- Powder properties research
- Single-crystal Cultivation
- Cultivation
- Single crystal testing
- Structure analysis
- Solid State Screening
- Polymorph screening
- Salt/co-crystal screening & selection
- Amorphous forms preparation
- Crystallization Process R&D
- Crystallization process development & optimization
- Commercial manufacturing of drug intermediate materials or/and APIs in
specific solid-state form
Streamline of Polymorphic Research CMC Services
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Drug Discovery
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Pre-clinical research
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Clinical Phase I
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Clinical Phase II
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Clinical Phase III
- Commercialization
- Polymorphic screening and salt screening and selection for primary definition the solid-state form for pharmacodynamic and toxicological studies
- Further solid state screening and or selection for being available in formulation R&D
- Comprehensive screenings for IND
- Polymorph and salt screening for prolonging drug life cycle
- 6 ~ 8 weeks
- 8 ~12 weeks
- 3 ~ 6 Months
- Custom
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Crystallization process study 10~12 weeks
Why Partner with ChemExpress
Extensive Project Experience
As of 2025, the core team leader has more than 12 years of experience in solid-state chemistry and has successfully delivered 200+ solid state screening/crystallization process development and optimization projects
Professional Equipment
Equipped with a variety of advanced solid-state analysis instruments and R&D-scale crystallization equipment (mg-g scale), further supported by comprehensive analytical platform resources
End-to-End Services
From pre-clinical research to kilogram-scale process development and commercialization, including scale-up and production of highly challenging metastable polymorphs and amorphous forms
Key Equipment
Case Study
Crystallization Process Development
Background: The customer's original supplier failed process validation (PV) manufacturing, and the project was transferred to ChemExpress' solid-state chemistry research team for commercial-scale crystallization process development.
Solution: The physicochemical properties of polymorphic forms of the drug substance were systematically studied. Two crystallization process routes were developed and optimized, significantly improving crystal quality. Quantitative analysis of multiple polymorphic forms was completed, along with pre-PV batch technical support.
Deliverables: Crystal quality significantly surpassed that of the original supplier, successfully enabling commercial production.
FAQs
Pharmaceutical solid-state research involves the systematic study of the solid-state forms of an API, including polymorphs, salt forms, co-crystals, and amorphous forms. Different solid-state forms directly impact solubility, stability, bioavailability, and processability — making solid-state research a core component of CMC development and an important regulatory requirement for drug approval.
1. Confirmation of the absolute configuration of the compound;
2. Selection of the most suitable crystal form for pharmaceutical use;
3. Development of robust crystallization processes to stably and controllably produce specific crystal forms;
4. Issues such as oiling out, uncontrolled precipitation, and particle size inconsistency in intermediates & active pharmaceutical ingredients (APIs);
5. Circumvention of crystal form patents for APIs.
Leveraging professional experience and advanced equipment, ChemExpress provides one-stop CMC solutions from early polymorph screening to crystallization scale-up, efficiently resolving complex solid-state challenges to accelerate drug commercialization.
Polymorph and salt form screening is typically initiated during the pre-clinical stage to ensure the optimal solid-state form is selected before entering clinical studies. Early screening helps mitigate downstream risks related to patent disputes, process stability, and regulatory challenges, ultimately accelerating the drug approval timeline.
