| CAS No. 141-78-6 Product Description: Eastman™ Ethyl Acetate, NF/EP is a colorless, fragrant, low-boiling solvent. As a bulk pharmaceutical excipient, Ethyl Acetate, NF/EP meets the National Formulary (NF) and European Pharmacopoeia (EP) monograph specifications. Features of this product include: - Produced in compliance with the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients 2006
- Produced at only one location (Longview, TX)
- Produced as discrete batches
- Quarantined after production is complete
- Batch record review by QA prior to release
- Validated test methods
- Residual Solvents testing
- Product is filtered when loading to shipping containers
- Shipping containers cleaned to food grade standards
- Prior contents of shipping containers verified not to be toxics/poisons
- Impurity profiling program
- Stability monitoring program
- Increased record retention
The chemical substances for this product are listed as Inert Ingredients Permitted for Use in Nonfood Use Pesticide Products, and in Food Use Pesticide Products with limitations, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).Application/Uses: - Manufacture of Active Pharmaceutical Ingredients (APIs)
- Pharmaceutical excipient
Key Attributes:- Batch storage
- High assay
- Inert - Food use with limitations
- Inert - Nonfood use
- ISO certified
- Meets National Formulary (NF) and European Pharmacopoeia (EP) Monograph Specifications
- Produced under cGMP
- QA shipment batch record review
- Readily biodegradable
- Validated process
Information provided by Eastman |
