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13 Nov 2024
Improving the Manufacture of mRNA Biologics
13 Nov 2024
Crystal Pharmatech Solid State Characterization Service, which is referred to as Focused Analytical Solids Testing (FAST), covers many routine analyses encountered during pharmaceutical development. The FAST concept is directly aligned with our goal of partnering with organizations instead of merely providing data. Below table lists the sample amount and turnround time required for the different test items.
Test Item | Sample Amount (mg) | Turnaround Time (working days) | Test Item | Sample Amount (mg) | Turnaround Time (working days) | |
X-ray power diffraction(XRPD) | 2-50 | 2 | HPLC (Assay) | 30-50 | 5 | |
Particle Size Distribution (PSD) | 50-100 | 3-5 | CG Residual Solvents | 30-50 | 5 | |
DSC (10℃/min) | 2-20 | 2 | pKa | 5-10 | 2 | |
mDSC (3℃/min) | 2-20 | 2 | logP/D | 5-10 | 3 | |
TGA (10℃/min) | 2-20 | 2 | Jet Milling | 1,000 (1 g) | 2 | |
Polarized Light Microscopy (PLM) | 2-20 | 2 | BET | > 500 | 5 | |
Dynamic Vapor Sorption (DVS) | 20-100 | 5 | LC-CAD | 10-20 | 5 | |
KF | 100 | 2 | SCXRD | 50 | 5 | |
Hot-Stage Microscopy | 2-20 | 2 | Dispersion Batch | 10,000 (10 g) | 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 |