Solid-State Characterization and FAST Analysis

Solid-state properties of an API can appear stable under controlled conditions but may change when exposed to routine stresses during pharmaceutical development. Unexpected polymorphic transitions, hydrate formation, or structural disorder can introduce formulation variability, delay clinical studies, and lead to costly redevelopment.

Early solid-state characterization enables proactive risk assessment by evaluating how APIs respond to environmental and processing conditions such as moisture, temperature, mechanical stress, and long-term storage.

Moisture and Temperature

Identify risks of hydrate formation or polymorphic transformation under environmental exposure.

Processing Stress

Evaluate structural disorder introduced during milling, blending, and compaction.

Storage Stability

Assess potential recrystallization or phase changes across the intended shelf life.

Focused Analytical Solids Testing (FAST) for Solid-State Characterization

Selecting the right analytical tests early in development is critical for identifying potential solid-state risks and API property changes before they impact formulation or manufacturing. Crystal Pharmatech's Solid-State Characterization service — known as Focused Analytical Solids Testing (FAST) — provides targeted analytical testing to evaluate key physical and chemical properties during early pharmaceutical development.

The FAST approach prioritizes fit-for-purpose analytical testing to rapidly generate actionable insights rather than large volumes of raw data. By combining complementary analytical techniques, FAST helps scientists understand polymorphism, stability, physicochemical properties, and formulation-relevant attributes that influence downstream development decisions.

Core Solid-State and Analytical Testing Capabilities

Test Item	Sample (mg)	Days	Test Item	Sample (mg)	Days
XRPD	2–50	2	HPLC (Assay)	30–50	5
Particle Size (PSD)	50–100	3–5	GC Residual Solvents	30–50	5
DSC (10°C/min)	2–20	2	pKa	5–10	2
mDSC (3°C/min)	2–20	2	logP/D	5–10	3
TGA (10°C/min)	2–20	2	Jet Milling	1,000 (1g)	2
PLM	2–20	2	BET	>500	5
DVS	20–100	5	LC-CAD	10–20	5
Karl Fischer (KF)	100	2	SCXRD	50	5
Hot-Stage Microscopy	2–20	2	Dispersion Batch	10,000	Quote
FTIR	30–50	2	MicroED	10	Quote
Solution NMR (1H)	10	2	qNMR for Purity	10	7
ssNMR	50–500	2	qNMR with Linearity	20	7
HPLC (Purity)	10–20	2	Additional Processing	N/A	N/A

Click here to access: "Focused Analytical Solids Testing (FAST)" Online Form

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