AVAILABILITY OF FISH OIL TEST MATERIALS

NIH GUIDE, Volume 23, Number 32, August 26, 1994



P.T. 34



Keywords:

  Chemicals/Materials+ 



National Institutes of Health



This notice supplements the previous announcement published in the NIH

Guide for Grants and Contracts, Vol. 19, No. 11, March 16, 1990.



SUMMARY AND PURPOSE



Additional Test Materials Currently Available



The Fish Oil Test Materials Program announces the availability of

purified EPA (approx. 90 %) and DHA (approx. 90%) in kilogram

quantities to qualified applicants conducting research studies.



o  EPA ethyl ester, packaged in 1 gm soft gelatin capsules (contain

tocopherols(1-2 mg/g) and TBHQ(.02%)

o  DHA ethyl ester, packaged in 1 gm soft gelatin capsules (contain

tocopherols(1-2 mg/g) and TBHQ(.02%)

o  Placebo ethyl esters, packaged in 1 gm soft gelatin capsules

(described with other products listing)



Processing and Specifications of Biomedical Test Materials



o  EPA Ethyl Ester



The ethyl ester of EPA is prepared from fish oil using

transesterification, short-path distillation and urea adduction to

yield an n-3 ethyl ester concentrate.  The purified ethyl ester of EPA

is attained by preparative chromatographic techniques.  The product

contains 95% ethyl esters; of the ethyl esters EPA is 95%, other n-3's

are <4%, n-6's are <1% and other fatty acid esters are <1%.  It

contains 0.2 mg/g TBHQ as antioxidant and 2 mg/g tocopherols.



o  DHA Ethyl Ester



The ethyl ester of DHA is prepared from fish oil using

transesterification, short-path distillation and urea adduction to

yield an n-3 ethyl ester concentrate.  The purified ethyl ester of DHA

is attained by preparative chromatographic techniques.  The product

contains >95% ethyl esters; of the ethyl esters DHA is 86%, other n-3's

are <9%, n-6's are <3% and other fatty acid esters are <1%.  It

contains 0.2 mg/g TBHQ as antioxidant and 2 mg/g tocopherols.



FISH OIL TEST MATERIALS PROGRAM



The Fish Oil Test Materials Program is administered by the National

Institute on Alcohol Abuse and Alcoholism, NIH.  The program was

established in 1986 through the cooperation of the National Institutes

of Health (NIH), the Alcohol, Drug Abuse, and Mental Health

Administration (ADAMHA), and the National Oceanic and Atmospheric

Administration/Department of Commerce (NOAA/DOC).  This program has

been designed to provide a long-term, consistent supply of

quality-assured/quality-controlled test materials to researchers to

facilitate the evaluation of the role of omega-3 fatty acids in health

and disease.



Fish Oil Test Materials Advisory Committee



A Fish Oil Test Materials Advisory Committee (FOTMAC) is chaired by

scientific staff from NIH and is composed of scientists representing

the funding agencies (NIH), the research community, Department of

Commerce (DOC) and the Food and Drug Administration (FDA).  The FOTMAC

provides scientific advice to the DOC regarding the types of materials

needed by research scientists, shipping procedures for the materials,

and additional quality control and production issues.  The committee is

advisory to the Fish Oil Test Materials Program on general programmatic

issues such as future directions, and has produced an information sheet

on Considerations in the Study of the Effects of Dietary Fish Oils.  In

addition, the committee provided guidance to DOC during the production

of the Drug Master File submitted to the FDA by the FOTMAC.  Manuals on

Analytical Methods for the Quality Assurance of Fish Oil, Production

Methods/Safety and Distribution were produced by the DOC and are

available to investigators.



Fish Oil Test Materials Distribution Committee



A Fish Oil Test Materials Distribution Committee (FOTMDC) is composed

of NIH and other Federal scientists.  The Distribution committee

processes the applications received from investigators, advises the DOC

of applicants that have fulfilled the application process, and makes

recommendations regarding the distribution of requested materials.



Other Test Materials Currently Available



o  n-3 ethyl ester concentrate, prepared from menhaden oil, bulk packed

or soft-gel encapsulated (80% n-3 fatty acids including EPA and DHA)



o  Ethyl esters of olive oil, corn oil, and safflower oil (70%

linoleic), bulk packed or soft-gel encapsulated



o  Deodorized menhaden oil, bulk packed or soft-gel encapsulated



o  Commercial preparations of corn, olive, or safflower oil, soft-gel

encapsulated only



o  DHA Ethyl Ester and EPA Ethyl Ester in small gram quantities, bulk

packed



Processing and Specification of Biomedical Test Materials



o  n-3 Ethyl Ester Concentrate



The n-3 ethyl ester concentrate is prepared from vacuum-deodorized

menhaden oil using transesterification, urea adduction and short-path

distillation.  The concentrate contains >90% ethyl esters, of which

approximately 80% are n-3 fatty acid ethyl esters (44% EPA, 24% DHA,

10-12% other n-3 fatty acid ethyl esters), 3% C18 (other than n-3), 6%

C16 and the remainder as other esters.  It contains 0.2 mg/g TBHQ as

antioxidant, 2 mg/g tocopherols and 2.0 mg/g cholesterol.  The

concentrate is available in 1 g soft-gel capsules (100 capsules/bottle)

or packaged in bulk in quantities suitable to investigators' needs.



o  Placebo Ethyl Esters



The olive, corn and safflower ethyl esters contain >85% esters. The

olive oil ethyl esters contain approximately 70% oleic acid, 10% C16,

and 6% C18 (<6 mg/g n-3) fatty acid ethyl esters.  The corn oil ethyl

ester contains approximately 50% linoleic, 23% oleic acid and 10% C16

(>6 mg/g n-3) fatty acids.  The safflower ethyl esters contain

approximately 72% linoleic, 8% oleic and 6% C16 (>2 mg/g n-3) fatty

acids. The preparations are available in 1 g soft-gel capsules (100

capsules/bottle) or packaged in bulk in quantities suitable to

investigators' needs.



o  Deodorized Menhaden Oil



Deodorized menhaden oil is prepared from oil that has been winterized

and alkali refined; it is processed through a two stage wiped-film

evaporator to remove cholesterol, volatile oxidation products and any

traces of organic contaminants.  The oil contains approximately 30% n-3

fatty acids in the triglyceride form; 14% EPA, 8% DHA, 8% other n-3.

It contains 0.2 mg/g TBHQ as antioxidant, 2 mg/g tocopherols and 2.0

mg/g cholesterol.  The deodorized oil is available in 1 g soft-gel

capsules (100 capsules/bottle) or is packaged in bulk quantities

suitable to investigates needs.  Special requests for antioxidants-free

oil will be considered, e.g., for studies involving varying levels of

antioxidants.



o  Placebo Oils



Commercial preparations of corn, olive, and safflower oil have been

soft-gel encapsulated to serve as placebos for studies involving

encapsulated menhaden oil.  These oils contain 0.2 mg/g TBHQ as

antioxidant and 2 mg/g tocopherols.  The major fatty acids for each oil

are:  corn (58% 18:2n-6, 26% 19:1n-9) olive 17% 18:2n-6, 57% 18:1n-9),

safflower 80% 18:2n-6, 9% 18:1n-9).  They are available in 1 g soft-gel

capsules (100 capsules/bottle).  Although vegetable oils will not be

supplied in bulk form, investigators may request analysis of

antioxidants and tocopherol levels in vegetable oils that they purchase

for their studies.



APPLICATION PROCEDURES



To qualify to receive materials described in this announcement the

applicant must:  (1) have peer-reviewed research indicating the need

for the requested materials, and (2) submit a correctly completed

application form and a signed waiver of liability.  The committee will

not be responsible for assessing the scientific merit of the

application.  Regulations on human subjects and animal research apply.

In accordance with federal regulations, an IND number will be required

for the use of these materials in human studies.  The FOTMAC has

established a drug master file at the FDA that includes manufacturing,

chemical composition, and toxicological data relevant to these

products.  Investigators approved for the use of NOAA/DOC materials may

reference this file in order to expedite their IND requests.

Availability of materials are contingent on DOC/NOAA production

capabilities.  When prioritization is necessary, the order will be:

(1) NIH funded, (2) other U.S. government funded, (3) peer-reviewed,

other funded, (4) NIH approved, not funded, and (5) other.



Kilogram quantities of purified EPA ethyl ester and DHA ethyl ester are

available for research purposes. The awarded materials are provided

free of charge (Researchers are asked to pay shipping costs).  For

further information, contact Dr. Patricia Fair at (803) 762-1200.



Additional information will be provided to the investigator including

extensive quality assurance data for each lot of test material shipped,

stability data and storage instructions.



INQUIRIES



Investigators may obtain further information and apply for available

fish oil test materials for relevant studies by requesting an

application form from:



Fish Oil Test Materials Program

Program Coordinator

National Institute on Alcohol Abuse and Alcoholism

DANAC #4, Room 55C

12501 Washington Avenue

Rockville, MD  20852

Telephone:  (301) 443-2393

FAX:  (301) 594-0035



.


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