This
is to certify that the product
ASO® or AO2®, Activated Oxygen
Concentrate ASO 25% Jozzer Hyper Oxygen Drops
Contains the following ingredients (by
percentage of total volume):
Distilled Water (72.72%) CAS 7732-18.5
Molecules of ASO® Activated Stabilized Oxygen (25.0%)
Dissolved Trace Minerals (Western Analysis Assay) and Sodium
Chloride (2.28%) CAS 7647-14-5
Other Analytical Specifications:
Specific Gravity: 1.016 23º/23º C
Density: 1.016 g/cm3
pH: 8.46
Shelf Life/Stability: Three (3) Years from Manufacturing Date
Non-Toxicity:
ASO® was independently tested by SGS USA and found to have
no oral nor dermal toxicity*. ASO® is completely non-toxic,
biodegradable, non-caustic and non-flammable. ASO® contains
natural ingredients including iodized sea salt and distilled
water. It contains no microbiological contaminants, no pesticides,
is naturally biocidal and contains no animal nor vegetable products
or by-products.
SPECIFICATION RANGE METHOD RESULT DETERMINATION
Specific Gravity: 1.00 to 1.06 Hydrometer 1.016 Passed
Density: 1.00 to 1.06 Digital Meter 1.016 Passed
pH: 0 to 14 Digital Meter 8.46 Passed
Shelf Life: N/A Chamber 3 years Passed
A BRIEF EXPLANATION OF THE ASO® MANUFACTURING PROCESS:
Materials: USP Food Grade Sodium Chloride
(CAS 7647-14-5)
Distilled water (CAS 7732-18-5)
Equipment: HDPE Processing Tank
Rare Earth Proprietary Anodes & Cathodes
Mixer
Preparation/Process:
Triple distilled water is transferred to HDPE processing tank
where the sodium chloride is introduced to the water. The distilled
water is then agitated by the mixer until all the salt is dissolved
into ionic form.
ASO® is manufactured in an F.D.A. approved GMP laboratory
designated for the manufacturing of dietary supplements. The
process involves the disassociation of oxygen molecules from
water molecules in an electrolytic bath containing a mixture
of water and sodium chloride. A regulated current is then applied
to two proprietary composite metal electrodes. The hydrogen
gas is released and the oxygen molecules are stabilized in the
electrolytic solution containing both the ASO® molecules
and trace minerals from the sodium chloride.
IMPURITIES
AND ACCEPTANCE STANDARDS:
The ASO® is filtered on-line into an HDPE food grade plastic
drum. Inspection and analysis is made for product conformance
and quality. Once assured that product meets standards, the
container is mechanically sealed and stored in a cool dry place.
GMO free:
NO GMO have been used in any phase of the manufacturing process.
ASO® Activated Oxygen is a dietary supplement manufactured
in the United States of America. To the best of our knowledge,
ASO® is not derived from genetically modified starting raw
materials, or additives that are derived from genetically modified
organisms, and do not contain detectable levels of genetically
modified materials, (known as PCR negative). It is our understanding
that the EU labeling requirements are based on the presence
of detectable levels of transgenic material. Based on this information,
this product will not, on its own, require the labeling of these
foodstuffs and food ingredients as indicated in (EC) No. 1829/2003
and (EC) No. 1830/2003, (which came into law on the 7th of November,
2003) on the authorization, labeling, and traceability of genetically
modified organisms in food and feed. This product has not been
treated with ionizing radiations (gamma rays).
The chemical structure formula for the ASO® molecule is:
Activated Oxygen (ASO®) is exclusively
manufactured for and distributed by Connections Group, Inc.
under the name of Berkana and it’s contract laboratories
and manufacturing facilities that meet or exceed the United
States Food and Drug Administration (F.D.A.) and United States
Occupational and Safety Health Act (O.S.H.A.) standards. Further,
BERKANA warrantees that each sealed drum of ASO® has a three-year
shelf life from manufacturing date. ASO® was tested using
digital density/Specific Gravity Meters, Thermometers and Hydrometers
to ASTM Specifications and in accordance to ASTM Testing Methods.
*Copies of test reports are available upon written request.
ASO® does not consist, contain or is produced from GMOs
(genetically modified organisms).
MINERAL
ANALYSIS
ASO® Concentrate (25% Strength)
CONCENTRATION AMT Per
ELEMENT (25% Strength) 1 mL Serv.
Aluminum mg/L 1.95 0.00195
Antimony mg/L <0.05 0.00005
Arsenic mg/L <0.03 0.00003
Barium mg/L 0.02 0.00002
Beryllium mg/L 0.001 0.000001
Bismuth mg/L 0.02 0.00002
Boron mg/L 0.03 0.00003
Bromine mg/L <0.05 0.00005
Cadmium mg/L <0.005 0.000005
Calcium mg/L 7.9 0.0079
Carbon mg/L 370 0.37
Cerium mg/L <0.04 0.00004
Cesium mg/L <0.02 0.00002
Chloride mg/L 15,900.00 15.9
Chromium mg/L 0.09 0.00009
Cobalt mg/L <0.03 0.00003
Copper mg/L 0.008 0.000008
Dysprosium mg/L <0.01 0.00001
Erbium mg/L <0.03 0.00003
Europium mg/L <0.03 0.00003
Fluoride mg/L 0.08 0.00008
Gadolinium mg/L <0.02 0.00002
Gallium mg/L <0.03 0.00003
Germanium mg/L 0.03 0.00003
Gold mg/L <0.02 0.00002
Hafnium mg/L <0.01 0.00001
Holmium mg/L <0.01 0.00001
Indium mg/L <0.03 0.00003
Iodine mg/L 0.11 0.00011
Iridium mg/L <0.02 0.00002
Iron mg/L 0.09 0.00009
Lanthanum mg/L <0.02 0.00002
Lead mg/L <0.02 0.00002
Lithium mg/L 0.15 0.00015
Lutetium mg/L <0.03 0.00003
Magnesium mg/L 28 0.028
Manganese mg/L <0.03 0.00003
Mercury mg/L <0.001 0.000001
CONCENTRATION AMT Per
ELEMENT (25% Strength) 1 mL Serv.
Molybdenum mg/L <0.02 0.00002
Neodymium mg/L <0.01 0.00001
Nickel mg/L <0.02 0.00002
Niobium mg/L 0.03 0.00003
Osmium mg/L <0.02 0.00002
Palladium mg/L <0.02 0.00002
Phosphorus mg/L 26 0.026
Platinum mg/L <0.03 0.00003
Potassium mg/L 38 0.038
Praseodymium mg/L <0.04 0.00004
Rhenium mg/L <0.01 0.00001
Rhodium mg/L <0.01 0.00001
Rubidium mg/L 0.02 0.00002
Ruthenium mg/L <0.02 0.00002
Samarium mg/L <0.01 0.00001
Scandium mg/L <0.03 0.00003
Selenium mg/L <0.04 0.00004
Silicon mg/L 9.7 0.0097
Silver mg/L <0.03 0.00003
Sodium mg/L 6,400.00 6.4
Strontium mg/L 0.19 0.00019
Sulfur mg/L 13.9 0.0139
Tantalum mg/L 0.02 0.00002
Tellurium mg/L <0.02 0.00002
Terbium mg/L 0.02 0.00002
Thallium mg/L 0.04 0.00004
Thorium mg/L <0.02 0.00002
Thulium mg/L <0.01 0.00001
Tin mg/L 0.02 0.00002
Titanium mg/L <0.005 0.000005
Tungsten mg/L <0.08 0.00008
Vanadium mg/L 0.01 0.00001
Ytterbium mg/L <0.003 0.000003
Yttrium mg/L 0.004 0.000004
Zinc mg/L 0.35 0.00035
Zirconium mg/L 0.04 0.00004
TOTAL 22796.823 22.797807
MINERALS
IN MG
MICROBIOLOGICAL ANALYSIS
ASO® Super Concentrate (25% Strength)
ASO® has been shown to be an effective anti-microbial agent
pursuant to extensive independent testing. The summary of results
of said testing indicate the following:
Use Dilution Method 955.14
Disinfectant Efficacy
Using 5% Strength ASO®
Staphylococcus aureus ATCC 6538
Dilution 1:60 5 MIN + 10 MIN 0 15 MIN 0
Salmonella choleraesius ATCC 10708
Dilution 1:90 5 MIN + 10 MIN 0 15 MIN 0
Pseudomonas aeruginosa ATCC 15442
Dilution 1:80 5 MIN + 10 MIN + 15 MIN 0
+
= GROWTH
0 = NO GROWTH
Modified Antimicrobial Preservative Effectiveness Test
Using 5% Strength ASO®
(Dilution 1:1)
Staphylococcus aureus ATCC 6538 0 HR
> 99.9% 24 HR > 99.9%
Pseudomonas aeruginosa ATCC 9027 0 HR > 99.9% 24 HR >
99.9%
Escherichia coli ATCC 8739 0 HR >99.9% 24 HR > 99.9%
Candida albicans ATCC 10231 0 HR > 99.9% 24 HR > 99.9%
Aspergillus niger ATCC 16404 0 HR 99.5% 24 HR > 99.9%
Aspergillus flavus ATCC 9643 0 HR 99.8% 24 HR > 99.9%
Minimum Inhibitory Concentration
Using 25% Strength ASO®
24 hour Test Incubation
60% Dilution 80% Dilution
Escherichia coli 0157:H7 ATCC 43985 NO NO
Pseudomonas aeruginosa ATCC 15442 NO YES
Salmonella choleraesuis ATCC 10708 NO NO
Staphyloccus aureus ATCC 6538 NO NO
NO = NO GROWTH AT THE DILUTION RATE
YES = GROWTH AT THE DILUTION RATE
Reference: SGS USA, Inc. and Nelson Laboratories.
Test reports available upon written request.
Note: The above test was conducted on 25% ASO®. 35% ASO®
is 140% stronger and similar, or better, results would be expected.
SHELF LIFE (Stability) ASO® Activated Oxygen
There are no formation of Hydrogen Peroxide
(H2O2) And/Or Chlorine Dioxide (ClO2)
ASO® Accelerated Standard Shelf Life
testing for food (nutritional) supplements
Month Color Taste Odor Form Particulates
ASO® mg/L % Change pH
1 Clear Salty Halogen Liquid None 350,000 0 7.4
6 Clear Salty Halogen Liquid None 350,000 0 7.4
12 Clear Salty Halogen Liquid None 350,000 0 7.4
18 Clear Salty Halogen Liquid None 350,000 0 7.4
24 Clear Salty Halogen Liquid None 350,000 0 7.4
Product samples maintained at the following
base temperatures of:
67º F (20º C) ± 1.75º @ 50% humidity
77º F (25º C) ± 1.75º @ 60% humidity
104º F (40º C) ± 1.75º @ 75% humidity
Note that there were no statistically significant data in any
of the three samples regardless of temperature or humidity differences.
LaMotte Instrument Co. HP40 Code 3188 and Lamotte Instrument
Co. Model EDO Code 7414 Dissolved Oxygen Test Kits. Source:
Lamotte Instrument Co., Chestertown, MD 21620.
ClO2 and/or H2O2 Formation:
Accelerated Standard Shelf Life testing for food (nutritional)
supplements
Month ClO2 mg/L % Change H2O2 mg/L %
Change
1 0 0 0 0
6 0 0 0 0
12 0 0 0 0
18 0 0 0 0
24 0 0 0 0
Note that there was no formation of either
Hydrogen Peroxide (H2O2) nor Chlorine Dioxide (ClO2) during
the test period in the solution of ASO®.
For H2O2: LaMotte Instrument Co. HP40
Code 3188 and Lamotte Instrument Co. Model EDO Code 7414 Dissolved
Oxygen Test Kits.
For ClO2: LaMotte Instrument Co. Model 3622 OctaSlide and Lamotte
Instrument Co. Model 3002 Chlorine Dioxide Insta Test Strips
Test Kits.
Source: Lamotte Instrument Co., Chestertown, MD 21620.
The above information is provided for
reference purposes. All products meet or exceed minimum quality
control and ingredient standards established by the U.S. Food
and Drug Administration governing the manufacture and sale for
distribution of dietary supplements and health and beauty products.
Shelf life refers to the average amount
of time ASO® may be stored without nutritional or organoleptic
(sensory) deterioration. A food product can deteriorate for
several reasons: aging, microbiological decay, chemical and
physical degradation, texture changes, etc. These modes of deterioration
are affected by many factors, both intrinsic (of or within the
product) and extrinsic (environmental or outside the product).
Controlling processing, packaging, handling and storing of the
product can slow deterioration of food products. BERKANA’s
expiration safety date refers to the length of time ASO®
can be expected to last without significant deterioration.
The dates assigned to ASO® are based
on intrinsic and extrinsic factors, and determined by systematic
study or empirical data. Systematic studies are designed to
simulate actual or potential storage and handling practices
of a given product and estimate shelf life through the course
of chemical and analytical testing at specific intervals throughout
the expected shelf life. Systematic studies may also rely on
accelerated testing when dealing with ASO® with expected
long shelf lives. In some cases, shelf life evaluations can
be made based on existing information, or empirical data.
Primary shelf life tests conducted on
ASO® have been conducted by independent laboratories on
standard test microorganisms. These reports are available, upon
request, from Connections Group, Inc.
Note that neither Hydrogen Peroxide not
Chlorine Dioxide is approved for human consumption as a dietary
supplement or as a food additive by the U.S.F.D.A. The test
data described above does not, in any way, or in any manner,
recommend the use of Hydrogen Peroxide or Chlorine Dioxide for
human consumption. This information is only proved for product
stability comparisons.
Toxicity:
ASO® has undergone rigid independent toxicity tests by SGS
USA, Inc. SGS conducted six different toxicity tests on ASO®.
For purposes of these studies, the “lethal dose”
(LD) or “lethal concentration” (LC) needed to be
quantified. Once this amount had been determined, the amount
was divided in half and was represented as half (50%) of the
amount of a substance that can cause death when consumed or
used. This is what is meant by the terms LD50 and LC50.
Of special note, in reviewing the tests
conducted by SGS, is the fact that there were no reported incidences
of death, (see necropsy findings,) for any of the laboratory
animals. In fact, without exception, all of the laboratory animals
exhibited healthy and weight gains indicating that ASO®
did not have any adverse affect on normal metabolic functions.
Complete copies of any of these tests are available upon request.
Tests included: Acute Oral Toxicity Testing,
Acute Dermal Toxicity Test (LD50), Acute Dermal Irritation/Corrosion
Test, Acute Inhalation (LC50) Toxicity Testing, Skin Sensitization
Test and Eye Irritation Test.
Here is a summary of SGS’s findings:
Acute Oral Toxicity Testing: “When tested as specified,
the submitted test substance, Stabilized Oxygen from BERKANA
at Full Strength Concentrated Solution, was determined to have
an acute oral LD50 greater than 5.0 g/kg.” (Non-Toxic)
Acute Dermal Toxicity Test (LD50): “When
tested as specified, Stabilized Oxygen from BERKANA at 20% Strength
Concentrated Solution was not acutely toxic to the test animals
following dermal application of the test substance at 2.0 g/kg.”
(Non-Toxic)
Acute Dermal Irritation/Corrosion Test:
“When tested as specified, Stabilized Oxygen Solution
from BERKANA at 20% Strength Concentrated Solution, did not
induce dermal irritation in the six test animals following a
4-hour dermal exposure.” (Practically Non-Irritating)
Acute Inhalation (LC50) Toxicity Testing:
“When tested as specified, Stabilized Oxygen Solution
from BERKANA at 40% Strength Concentrated Solution, was not
acutely toxic to the test animals following a four hour inhalation
exposure at a normal concentration of 23.9 mg/L (actual concentration
was 14.6 mg/L). The LC50 was estimated to be greater than 23.9
mg/L (actual concentration was 14.6 mg/L).”
Skin Sensitization Test: “When
tested as specified, Stabilized Oxygen from BERKANA at 20% Strength
Concentrated Solution, was not considered to be a skin sensitizing
agent. There were no significant differences in skin irritations
observed in the test animals and in the control animals on challenge.”
Eye Irritation Test: “When tested
as specified, the submitted test substance, Stabilized Oxygen
from BERKANA at 20% Strength Concentrated Solution, was not
an eye irritant.”
Other Chemical and Biological Data:
Standard Plate Count: N.D.
Coliform Group Bacteria Count: N.D.
Boron (as H3BO3): <.5 mg/L
Sulfide (as H2S/Hydrogen Sulfide): <.05 mg/L
F.D.A. Recognition of A.S.O.®
ASO® falls under and meets all of the U.S.A. D.S.H.E.A.
(Dietary and Supplement Health Education Act) regulations enacted
in 1997 for dietary supplements. ASO® and its supporting
literature is not intended to diagnose, treat, cure or prevent
any diseases or physiological conditions. Individuals taking
medications or under the are of physicians should always let
their health care providers know that they are taking dietary
supplements and should consult those providers before taking
any dietary supplements.
Ms. Barbara Schneeman, Director of The
United States Food and Drug Administration, Department of Health
and Human Services, Office of Nutritional products, Labeling
and Dietary Supplements, Center for Food Safety and Applied
Nutrition, pursuant to the provision of Rule 44 of the Federal
Rules of Civil Procedure, and Title 42, United States Code,
Section 3505, and 21 CFR 5.22, has issued Certificate of Free
Sale F00099418 for “ASO Therapeutic Formula”. Said
Certificate of Free Sale is available upon written request.
ASO® is sold under the following
trade names:
Jozzer Hyper Oxygen Drops ASO
AO2™ Activated Stabilized Oxygen
O4+™ Stabilized Oxygen
