Whitepaper
Pharmaceutical Solid-state Forms
14 Jul 2022
en
Solid-state properties may appear stable but can change under routine stress. Unexpected transitions can delay clinical studies and lead to costly redevelopment. Proactive evaluation ensures stability from discovery to shelf life.
Identify risks of hydrate formation or polymorphic transformation under environmental exposure.
Evaluate structural disorder introduced during milling, blending, and compaction.
Assess potential recrystallization or phase changes across the intended shelf life.
FAST prioritizes fit-for-purpose analytical testing to rapidly generate actionable insights rather than large volumes of raw data.
| 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 |
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Our capabilities span three specialized platforms:
Small Molecule
Crystal Bio Solutions
Crystal NAX
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