Pharmaceutical Grade DMF (EP/USP) - Sterile API Synthesis
Pharmaceutical Grade DMF (EP/USP) - Sterile API Synthesis Product Identity
GMP-grade DMF (C₃H₇NO) for cytotoxic drug synthesis, compliant with ICH Q7.
Unique Highlights
Endotoxin-Free: ≤0.25 EU/mL (LAL test)
Genotoxin Control: NDMA ≤0.01 ppm (LC-MS/MS)
Sterile Option: Gamma-irradiated (25kGy)
Application Case
Peptide coupling solvent for ADC drugs (DAR ≥7.8)
Residual solvent ≤410 ppm per FDA guidance
Technical Specification
| Standard | Requirement |
|---|---|
| USP <467> | Class 2 residual solvent |
| EP 10.0 | 2.4.24 compliance |
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