CRODAMOL EO

Ethyl Oleate NF

CRODAMOL EO is Ethyl Oleate and conforms to both the National Formulary (NF) and European Pharmacopoeia (EP) monographs.  Ethyl Oleate is the ester of ethanol and oleic acid (C18:1) and has the following structure:

CRODAMOL EO has applications in a number of pharmaceutical systems and offers the following functional benefits:

FUNCTIONAL BENEFITS

      Derived from raw materials of non-animal origin
      Excellent color profile
      Low viscosity
          Lipophilic vehicle
      Non-aqueous solvent for lipophilic drugs
      Non-occlusive emollient
      Good spreading agent
 

APPLICATIONS

Oral

Solvent for lipophilic Active Pharmaceutical Ingredients
Used as a flavor adjuvant, as outlined in 21 CFR § 172.515 Synthetic  Flavoring Substances and Adjuvants
May be used to dehydrate grapes to produce raisins, as described in 21 CFR § 172.225

Parenteral

    Vehicle for intra-muscular and subcutaneous injection
Solvent for lipophilic Active Pharmaceutical Ingredients
 Viscosity modifier for fixed oils
 

Topical

    Solvent for active pharmaceutical ingredients in ointments, creams and lotions
Functional excipient in transdermal delivery systems
Penetration enhancer
Viscosity modifier
Skin spreading modifier
Emollient
 

In topical preparations, CRODAMOL EO is effective as a vehicle or diluent for many active and inactive ingredients and is suitable as a replacement for mineral or vegetable oils.  In addition to its excellent solvent properties, CRODAMOL EO has very low reactivity with chemically sensitive pharmaceutical actives. As an emollient, CRODAMOL EO is non-occlusive and forms films that spread well. According to Croda's classification of emollient esters, CRODAMOL EO possesses a high Emollient Skin Spreading Factor.  The spreading and emollient properties of CRODAMOL EO may therefore be of benefit in improving both the aesthetics and applicational properties of many pharmaceutical creams.

Physicochemical Data

Figures are provided for reference purposes only and do not represent specification values. A selling specification is available on request.

Ethyl Oleate is soluble in mineral oil and isopropyl alcohol.

Regulatory Status

Ethyl Oleate is listed in the FDA Inactive Ingredients Guide. It is also cited in 21 CFR 172.225 and 21 CFR 172.515.

Storage

CRODAMOL EO is available in 396lb containers and is packaged under a nitrogen headspace. The product also contains approximately 100ppm BHT as an antioxidant.  CRODAMOL EO should be stored in a cool, dry place in a well-fitted closed container, protected from light.  Compatibility with plastic and rubber must be evaluated in each case, since their use as packaging materials can be affected by the solvent properties of Ethyl Oleate.

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