1 of 5 MarComm-2021-00597

03_210701e-00
Maxomega DHA 95 EE AS

|
P
Technical Information
a
g
e

Maxomega DHA 95 EE AS
Docosahexaenoic acid ethyl ester

July 2022 | MarComm-2021-00597/Page

1 of 5
 2 of 5 MarComm-2021-00597
03_210701e-00
Maxomega DHA 95 EE AS

|
P
a
1.gIntroduction
e
Maxomega DHA 95 EE AS is an oil containing minimum 95% of the primary omega-3
acid, docosahexaenoic acid (DHA) in ethyl ester (EE) form.

Omega-3 fatty acids in general are naturally occurring nutrients that are of high
importance for human health. They cannot be synthesized by the human body but are
vital for normal metabolism. Omega-3 fatty acids are polyunsaturated fatty acids with a
double bound from the 3rd carbon atom from the end (omega). The most abundant
omega-3 fatty acids are eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA)
and alfa-linoleic acid (ALA). EPA and DHA are long-chain fatty acids found in algal oil
and fish. EPA and DHA have been widely studied for medical and nutritional
applications.
Maxomega DHA 95 EE AS is produced from algal oil by several concentration and
purification steps including liquid chromatography and silica refining. The algal oil is
sourced from the micro organism Schizochytrium sp.
The only additional ingredient to DHA EE is the antioxidant dl-alpha tocopherol which
is added in a concentration of approximately 0,2%. The minor part (4-5%) that is not
DHA EE, consists of other naturally occurring fatty acid in ethyl ester form, including
other omega-3 fatty acids.
Due to the high amount of unsaturated fatty acids, the product will easily oxidize in
contact with air, and needs to be protected from contact with oxygen. The container is
therefore flushed with nitrogen prior to, during and after filling with DHA 95 EE.
Maxomega DHA 95 EE AS or the genric substance Docosahexaenoic acid ethyl ester
has no approved medical indication, but is under development and testing whithin
pharmaceutical applications.
DHA at lower concentrations sourced from fish or algae are used in nutritional
products, either in ethyl ester or triglycerides form.
 3 of 5 MarComm-2021-00597
03_210701e-00
Maxomega DHA 95 EE AS

|
P
a
2.gDescription Name
Maxomega DHA 95 EE AS
e
United States Adopted Names (USAN)
NA

International nonproprietary name (INN)

Doconexent ethyl

Pharmacopeia name
NA
Chemical names
Ethyl all cis-4, 7,10,13,16, 19-Docosahexaenoate, Docosahexaenoic acid ethyl ester
Cervonic acid ethyl ester, Ethyl-DHA, DHA EE, C22:6n-3 ethyl ester

CAS-No
81926-94-5

Molecular formula
C24H36O2

Relative Molecular mass

356.54

Structural formula

DHA EE
 09_130829e-03 November 2017 Page 5 of 5 Pluronic® FT PE 6100
MarComm-2021-00597
4 of 5 Maxomega™ DHA 95 EE

3. Physical and chemical

properties
Appearance
Maxomega DHA 96 EE AS is a colourless-to-yellow, clear mobile liquid.

Solubility
Maxomega DHA 95 EE AS is practically insoluble in water, very soluble in organic solvents
such as hexane, acetone, ethanol, and methanol.

Boiling point > 400°C at 1.013hPa

Flash point >100°C

Vapour pressure Negliable
Density 0.914 g/cm3 (20°C)
Partioning coefficient in 9.4
octanol/water (logPow)

4. Medical information Applications

Maxomega DHA 95 EE AS is a highly concentated omega-3 oil containing mainly
only one of the omega-3 fatty acids, DHA in ethyl ester form. For application,
Maxomega DHA 95 EE AS is typically filled into soft gelatin capsules as the sole fill
ingredient. These soft gelatin capsules are suitable for Maxomega DHA EE AS
because it protects the active substance from oxygen and masks taste and odour.
In consequence, Maxomega DHA EE AS is not suitable for liquid multidose
formulations as it will readily oxidize in contact with atmospheric oxygen, and also
has an unpleasant taste and odour.

Therapeutic indication
Maxomega DHA 95 EE AS is not used in any licenced pharmaceutical drug products,
and there are no approved therapeutic indications for the generic substance
Docosahexaenoic acid ethyl ester.
 09_130829e-03 November 2017 Page 5 of 5 Pluronic® FT PE 6100
MarComm-2021-00597
5 of 5 Maxomega™ DHA 95 EE

5. Handling & Safety Please refer to the individual safety data sheet (SDS) for instructions on
safe and proper handling and disposal. Safety data sheets are sent with every
consignment or can be requested from your BASF sales representative.

Re-test period & Storage Conditions

Please refer to the document “Quality & Regulatory Product Information” which is
available in RegXcellence, RegXcellence® (force.com).

Packaging
The commercial product is filled in epoxy phenolic lined mild steel drums. The lining
is a golden brown colour. The drum closure is made of the same materials. The
product is stored under nitrogen atmosphere to prevent oxidation. The external
drum surface is blue.

6. Product specifications The current version of the product specifications are available at RegXellence,
RegXcellence® (force.com) or from your BASF sales representative.

7. Regulatory & Quality Please refer to the document Quality & Regulatory Product Information which is
available in RegXcellence,, RegXcellence® (force.com)

PRD and Article numbers

PRD-No.* Product name Article numbers Packaging

30635624 Maxomega DHA 95 EE AS 50461831 190kg steel drum

50430534 (sample) 0,1 kg aluminum bottle

* BASF’s commercial product number.

Disclaimer This document, or any answers or information provided herein by BASF, does not
constitute a legally binding obligation of BASF. While the descriptions, designs, data
and information contained herein are presented in good faith and believed to be
accurate, it is provided for your guidance only. Because many factors may affect
processing or application/use, we recommend that you make tests to determine
the suitability of a product for your particular purpose prior to use. It does not relieve
our customers from the obligation to perform a full inspection of the products upon
delivery or any other obligation. NO WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED
OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE PRODUCTS,
DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING THE
INTELLECTUAL PROPERTY RIGHTS OF OTHERS. IN NO CASE SHALL THE
DESCRIPTIONS, INFORMATION, DATA OR DESIGNS PROVIDED BE CONSIDERED A
PART OF OUR TERMS AND CONDITIONS OF SALE.
June 2021

BASF – Nutrition & Health – www.pharma-ingredients.basf.com