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Technical Data Sheet
Eastman™ Ethyl Acetate, NF/EP


Applications
  • Pharmaceutical chemicals
Key Attributes
  • Batch storage
  • High assay
  • ISO certified
  • Inert - Food use with limitations
  • Inert - Nonfood use
  • Meets National Formulary (NF) and European Pharmacopoeia (EP) Monograph Specifications
  • Produced under cGMP
  • QA shipment batch record review
  • Readily biodegradable
  • Validated process

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). For details on specific permissions, click here.



Typical Properties

PropertyTypical Value, Units
General
Acidity 
     as Acetic Acid0.10 wt % max.
Assay99.5 wt % min.
Boiling Point 
     @ 760 mm Hg75.5-78 °C (167.9-172.4 °F)
Color 
     Pt-Co10 max.
Dilution Ratio 
     Toluene3.1
     VMP Naphtha1.1
Empirical FormulaC4H8O2
Ethyl Alcohol0.01 wt % max.
Evaporation Rate 
     (n-butyl acetate = 1)4.1
Flash Point 
     Tag Closed Cup-4 °C (24 °F)
Freezing Point-84 °C (-118 °F)
Molecular Weight88.11
Refractive Index 
     @ 20°C1.37
Solubility 
     in Water, @ 20°C8 wt %
     Water in, @ 20°C3 wt %
Specific Gravity 
     @ 20°C/20°C0.9
Vapor Pressure 
     @ 20°C86 mm Hg
Water0.05 wt % max.
Wt/Vol 
     @ 20°C0.9 kg/L (7.51 lb/gal)



Comments
Properties reported here are typical of average lots. Eastman makes no representation that the material in any particular shipment will conform exactly to the values given.


Eastman and its marketing affiliates shall not be responsible for the use of this information, or of any product, method, or apparatus mentioned, and you must make your own determination of its suitability and completeness for your own use, for the protection of the environment, and for the health and safety of your employees and purchasers of your products. No warranty is made of the merchantability of fitness of any product, and nothing herein waives any of the Seller's conditions of sale.


4/3/2018 2:12:11 PM