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Protocols
& Quantification of
Diagnostic & Analytical Parameters for
"Certified Natural Beverage" |
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There
are three separate protocols involved in analyzing
and identifying products that fit the criteria for
“Certified Natural Beverages”.
| 1. |
Identification
of ingredients deemed not to be “Natural”
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| 2. |
Laboratory
Analysis of Products Submitted |
| 3. |
Low
Glycemic Human In-Vivo clinical trials |
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Factor
Number 1:
Natural Ingredients Criteria |
The
following ingredients are NOT considered
"NATURAL"and
are exempted from being included in a Certified Natural Beverage
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The
Food & Drug Administration has recently ruled that beverages
which contain HIGH FRUCTOSE CORN SYRUP may not be labeled
as “Natural.”
Therefore,
beverages that contain HIGH FRUCTOSE CORN SYRUP do not qualify
for the “Certified Natural Beverage” mark.
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Synthetic
& Chemical Sweeteners |
Beverages
that contain synthetic and/or chemical sweeteners do not
qualify for the “Certified Natural Beverage” mark. These
include:
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acesulfame potassium (ACE-K) |
•
aspartame |
•
cyclamates |
•
neotame |
•
saccharin |
•
sucralose |
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Sugar
alcohols (technically called polyols) are carbohydrates
that are neither sugars nor alcohols.
Beverages that contain sugar alcohols do not qualify for
the “Certified Natural Beverage” mark. These include:
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xylitol |
•
mannitol
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•
sorbitol
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•
isomalt
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•
maltitol
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•
maltitol
syrup
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lactitol |
•
erythritol |
In
diabetics, the glycemic response to sugar alcohols can be
profound. Sorbitol has been known to elevate blood sugar slower
than high glycemic sugars, but rapidly enough to cause postprandial
blood sugar elevation. Significant blood sugar elevation is
evidenced hours after consuming foods containing sugar alcohols
and/or sugar alcohol syrups.
Isomalt, a sugar alcohol, has been shown to cause moderate
to profound gastric distress, including diarrhea and flatulence.
In children age 4 to 14, isomalt was shown to cause diarrhea
in 25 % of the children. |
http://inchem.org/documents/jecfa/jecmono/v20je14.htm
Health
potential of polyols as sugar replacers, with emphasis on
low glycemic properties; Nutrition Research Reviews 2003;16:163-91.
British
Journal of Nutrition. 2005 Nov;94(5):643-6.Human gut microbiota
does not ferment erythritol.
Use of a new sugar substitute, erithritol, in the diet therapy
of type 2 diabetes patients. Voprosy Pitaniia. 2002;71(3):19-23.
Diabetes Spectrum
Volume 17, Number 3, 2004. Low Carbohydrate Food Facts and
Fallacies. Freeman et al |
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Beverages
that contain toxic glycosides, such as Licorice do not qualify
for the “Certified Natural Beverage” mark. Licorice glycosides
have been shown to cause spontaneous abortion in the first
trimester of pregnancy. Per the FDA Code of Federal Regulations
21, parts 170 to 199, Revised as of April 1, 2000, 184.1408,
Licorice and Licorice derivatives (glycyrrhiza) are not permitted
to be used as a nonnutritive sweetener in sugar substitutes.
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Ingredients
that Exacerbate
Type 2 Diabetes |
Type 2 Diabetes is a disease that is totally preventable given
acceptable preventive measures, such as diet and exercise.
Beverages that contain ingredients that have been clinically
proven to exacerbate Type 2 Diabetes include honey, molasses,
maple syrup, rice syrup, white grape juice, sucrose, and glucose
polymers. Beverages that contain these ingredients do not
qualify for the “Certified Natural Beverage” mark. |
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T-Acetylcysteine
is an antioxidant commonly used in dietary supplements that
can lead to pulmonary arterial hypertension, according to
research from the University of Virginia (UV) Health System.
The study examined the effect of N-acetylcysteine (NAC) and
the results, published in the Journal of Clinical Investigation,
indicate the antioxidant can form a red blood cell-derived
molecule that makes blood vessels think they are not getting
enough oxygen. This can lead to pulmonary arterial hypertension
(PAH), a condition characterized by high blood pressure in
the arteries carrying blood to the lungs. According to the
researchers, "NAC fools the body into thinking that
it has an oxygen shortage - We found that an NAC product formed
by red blood cells, know as a nitrosothiol, bypasses the normal
regulation of oxygen sensing. It tells the arteries in the
lung to 'remodel'; they become narrow, increasing the blood
pressure in the lungs and causing the right side of the heart
to swell." Beverages that contain T-Acetylcysteine
do not qualify for the “Certified Natural Beverage” mark.
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Independent
scientific evidence has clearly demonstrated the dangers of
ingesting modified or refined soy products in women. |
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Increased
Risk of Breast Cancer by
Refined Soy Products: |
Phytoestrogens
Dr. William Helferich
Professor
Department of Food Science and Human Nutrition
University of Illinois
Dietary
phytoestrogens & Breast Cancer: a complex safety issue
involving dose & timing of exposure
Genistein,
found in soy products, is a phytochemical with estrogenic
activity. Our research has focused on the effects dietary
genistein on growth of estrogen (E)-dependent mammary
tumors both in vitro and in vivo. Genistein
enhances the proliferation of E-dependent human breast
cancer tumor growth.
We have demonstrated that soy protein isolates processed
to contain low, medium, and high amounts of isoflavones
simulate tumor growth in a dose-dependent manner.
Expression of the estrogen-responsive gene pS2 was also
induced in response to treatment with dietary genistein.
We also evaluated the effect of dietary genistein in the
chemically induced (NMU) mammary cancer rodent model and
have demonstrated that dietary genistein stimulates growth
in this model. To evaluate whether dietary genistein interacts
with current anti-estrogen breast cancer therapy such
as tamoxifen (TAM), we implanted E-dependent tumors into
ovariectomized athymic mice and administered estradiol,
estradiol plus TAM, or estradiol, TAM plus dietary genistein.
In these studies dietary genistein was able to negate
the inhibitory effect of TAM on E-stimulated tumor growth.
Genistein is present in soy as part of a complex mixture
and the profile of these other bioactive compounds plays
an important role; we will present data on how the profile
of soy bioactive compounds can modulate genistein-stimulated,
estrogen-dependent tumor growth. In summary, genistein
can act as an estrogen agonist resulting in proliferation
of Edependent human breast cancer cells in vivo and can
negate the inhibitory effects of TAM on E-stimulated growth
of MCF-7 cell tumors (in vivo).
Soy,
breast cancer prevention link questioned
4/5/2006
Review: The review examined 18 studies conducted over
26 years, and were published in the Journal
of the National Cancer Institute.
"Because soy foods and soy supplements are widely
used, we conducted this first true meta-analysis to understand
what role soy foods might have on breast cancer risk,"
said scientists at Georgetown University Medical Center
and Johns Hopkins School of Medicine.
The new findings prompted the scientists to warn that
high dose soy supplements, taken by women to reduce their
risk of developing breast cancer, could do more harm than
good. Short-term studies of women taking such supplements
showed changes in breast cell growth that might actually
increase risk for breast cancer, while tests of refined
soy products in animals revealed increased tumor growth.
However, on the up side, the scientists said that there
is no risk when it comes to adding soy to the diet.
“The important aspect is eating actual soy-based foods
like tofu, not highly purified isoflavone supplements.
Highly refined components of soy can have very different
biological effects than eating tofu or drinking soymilk,”
said Dr Bruce Trock, associate professor of urology, epidemiology
and oncology at John Hopkins.
Beverages that contain Soy isolfavones and/or modified
or refined soy, do not qualify for the “Certified Natural
Beverage” mark.
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| Ingredient
in Energy Drinks Deemed Dangerous
Taurine: Culprit in Heart Function & Blood Pressure
Are Energy Drinks Safe for the Heart?
The AMERICAN HEART ASSOCIATION (AHA) recently
announced that energy drinks can dangerously affect heart
function and blood pressure. This announcement was made at
the American Heart Association’s Scientific Sessions and came
as quite a surprise to researchers. The AHA report was based
on clinical studies that demonstrated “Blood pressure and
heart rate levels increased in healthy adults who
drank two cans a day of a popular energy drink containing
Taurine and caffeine.”
Clinical trials involving energy drinks have shown that caffeine/Taurine
beverages can be dangerous to patients with heart disease,
and that drinking more than two cans a day can lead to higher
risk increases, even in healthy people (1). The researchers
advised people with high blood pressure and heart rate to
"avoid these drinks". The dangerous cocktail of
Taurine and caffeine was proven to cause pressure-induced
bradycardia which induced changes in heart rate and mean arterial
blood pressure.
In double-blind placebo trials, the strictest and
most accurate form of clinical trials, Red Bull was proven
to cause “significant decline in heart rate and an increase
in mean arterial blood pressure (2).” Red Bull contains
Taurine. |
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Energy
Drinks Jolt Blood Pressure |
MEDSCAPE,
Diabetes & Endocrinology; Energy Drinks Jolt Blood Pressure
(3), reported
that energy drinks containing caffeine and the amino acid
Taurine, “can adversely affect heart function and blood
pressure.”
The
results prompted researchers to advise people with hypertension
or heart disease to avoid energy drinks containing caffeine
and Taurine, as they could impact the effectiveness of
medication, as well as their blood pressure. Top Neurologists
have additionally confirmed that the combination of caffeine
and Taurine could cause seizures in humans. Researchers
stated that large consumption of energy drinks that contain
both caffeine and Taurine can provoke seizures (4). The
Neurologists reported that “Once the patients were
abstinent from the energy drinks, no recurrent seizures
were reported.”
Beverages
that contain Taurine do not qualify for the “Certified
Natural Beverage” mark.
Beverages
that contain high levels of caffeine (more than 150 mg/serving)
do not qualify for the “Certified Natural Beverage” mark.
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Bovine
Colostrum (Misoprostol): Misoprostol acid in colostrum causes
spontaneous abortion. Bovine Colostrum can cause spontaneous
abortion in young women due to its misoprostol content.
Bovine Colostrum is contraindicated in young women because
of its pro-abortive and teratogenic activity, which causes
stimulate uterine contractions, vaginal bleeding and miscarriage.
Beverages that contain Bovine Colostrum do not qualify for
the “Certified Natural Beverage” mark.
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Beverages
that contain Growth Hormone (GH) and/or Bovine GH do not
qualify for the “Certified Natural Beverage” mark. GH has
been shown to cause severe side effects in humans including
bone deformities. Beverages that contain Growth Hormone
do not qualify for the “Certified Natural Beverage” mark.
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Dangerous
Forms of L-Arginine |
Per
the Johns Hopkins University Human Clinical Trials on L-Arginine,
and the Journal of the American Medical Association (JAMA)
report on L-Arginine, some forms of the amino acid can cause
mortality.
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In
studies where the HCL form of L-arginine has been used,
metabolic acidosis and alterations in electrolytes have
been documented. It is therefore not recommended for human
use. Arginine HCL is the form that was used in the tragic
Johns Hopkins/JAMA clinical trial that caused mortalities.
Arginine
Pyroglutamate
Not recommended for human
use. Mechanism of action in the body is entirely speculative
according to the Physician’s Desk Reference (PDR).
Arginine
Ketoglutarate And Alpha-Ketoglutarate (AKG)
Researchers and physicians
caution that Alpha-ketoglutarate is not recommended for
human use.
Beverages
that contain the toxic forms of L-Arginine do not qualify
for the “Certified Natural Beverage” mark.
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Aristolochic
acid is judged to be "definitely hazardous"
because of documented kidney failure (sometimes requiring
transplant), deaths, and known potent cancer-causing properties.
Ephedra, Ma Huang, Comfrey, herbal androstenedione, chaparral,
germander, and kava are classified as "very likely
hazardous" because they are banned in other countries;
have generated an FDA warning; or are identified as causing
adverse effects in studies. Each is known by more than
one name. Abnormal liver function or damage, often irreversible,
and deaths have been reported for chaparral, comfrey,
germander, and kava. Bitter orange, organ/glandular extracts
(brain/adrenal/ pituitary/placenta/other gland "substance"
or "concentrate"), lobelia, pennyroyal oil,
skullcap, and yohimbe are considered "likely hazardous."
This category applies to ingredients for which there have
been adverse-event reports or because of theoretical risks.
Beverages
that contain any of these herbs do not qualify for the
“Certified Natural Beverage” mark.
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St.
John's Wort is not allowed in a beverage at any level
The
botanical, St. John’s Wort is not allowed, by the FDA,
for use as an ingredient in a beverage. St. John’s Wort
is not a GRAS substance or an approved food additive,
per FDA guidelines, and may not be used in beverages of
any type.
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Carmine
is a red coloring frequently used in yogurt, candies, fruit
drinks and sweets. Carmine is made from deceased ground-up
husks of female red beetles. The beetles, which originate
from the Canary Islands, are dried and ground up to create
a red paste. The red paste is then exported to the United
States and other countries where food is produced, and foods
to give them a strawberry-like color. Carmine is listed
on labels as "carmine", and not as "ground-up
red beetles." While carmine may not pose a health risk
to American consumers, it is an example of questionable
labeling, as consumers have the right to know when ground-up
insects are being used in their foods.
There are approximately 100 items in the grocery store with
carmine listed on the label (such as many strawberry yogurt
products). Beverages that contain Carmine do not qualify
for the “Certified Natural Beverage” mark.
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Sodium
Nitrite, when combined with saliva and digestive enzymes,
creates cancer-causing compounds known as nitrosamines.
In humans, consumption of Sodium Nitrite (SN) is correlated
with cancer, leukemia, and brain tumors. SN does not require
a warning on food labels.
Beverages
that contain Sodium Nitrite do not qualify for the “Certified
Natural Beverage” mark.
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Factor
Number 2:
Laboratory Analysis |
The
Protocol for utilization of the Natural Beverage Certification
requires submission of the beverage product for independent
laboratory analysis. Methods
of Testing are outlined below:
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Ash
Gravimetric Determination
Official Methods of Analysis of AOAC INTERNATIONAL (2000)
17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 923.03. (Modified)
Calories
By calculation
United States Department of Agriculture, "Composition
of Foods," Agricultural Handbook, No. 8, pp. 159-160,
(1982)
Calorimeter (Bomb calorimetry)
Oxygen Bomb Calorimetry and Combustion Methods, Manual
No. 160, Parr Instrument, Moline, IL, 1981. (Modified)
Carbohydrates
(total)
By calculation
Composition of Foods, Agriculture Handbook No. 8, United
States Department of Agriculture, pp. 164-165, 1975
Fat
Acid hydrolysis
Official
Methods of Analysis of AOAC INTERNATIONAL (2000) 17th
Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Methods 922.06, 954.02. (Modified)
Enzymatic
Hydrolization (methanol/chloroform)
Official Methods of Analysis of AOAC INTERNATIONAL (2000)
17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 983.23. (Modified)
Hydrolization
(Roese-Gottlieb Method)
Official
Methods of Analysis of AOAC INTERNATIONAL (2000) 17th
Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Methods 905.05, 920.11, 932.06. (Modified)
Soxhlet
Extraction
Official
Methods of Analysis of AOAC INTERNATIONAL (2000) 17th
Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 960.39. (Modified)
Moisture
Vacuum oven
Official Methods of Analysis of AOAC INTERNATIONAL (2000)
17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Methods 925.09, 926.08. (Modified)
Autotitration
(Karl Fischer method)
The United States Phamacopeia, Twenty-Fifth Revision,
United States Pharmacopeial Convention, Inc.: Rockville,
Maryland (2002)
Protein
Protein Analyzer (Dumas
Method)
Official
Methods of Analysis of AOAC INTERNATIONAL (2000) 17th
Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 968.06. (Modified)
Titration
(Kjeldahl Method)
Official
Methods of Analysis of AOAC INTERNATIONAL (2000) 17th
Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Methods 955.04, 979.09. (Modified)
Bradstreet,
R. B., The Kjeldahl Method for Organic Nitrogen, Academic
Press, New York, New York (1965). (Modified)
Kalthoff,
I. M., and Sandell, E. B., Quantitative Inorganic Analysis,
MacMillan, New York (1948). (Modified)
Proximate package (moisture,
ash, protein, and fat)
Gravimetric
Official
Methods of Analysis of AOAC INTERNATIONAL (2000) 17th
Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Methods 925.09, 926.08. (Modified)
Official
Methods of Analysis of AOAC INTERNATIONAL (2000) 17th
Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 923.03. (Modified)
Official
Methods of Analysis of AOAC INTERNATIONAL (2000) 17th
Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 968.06. (Modified)
Official
Methods of Official Methods of Analysis of AOAC INTERNATIONAL
(2000) 17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD,
USA, Official Methods 922.06 and 954.02. (Modified)
Specific
gravity
Calculation
The United States Phamacopeia, Twenty-Fifth Revision,
United States Pharmacopeial Convention, Inc.: Rockville,
Maryland (2002)
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Soy
(isoflavones)
Gas chromatography
Seo, A. and Morr, C.V., "Improved High-Performance
Liquid Chromatographic Analysis of Phenolic Acids and
Isoflavonoids from Soybean Protein Products," J.
Agric. Food Chem., 32(3): pp 530-533, 1984
Ephedra
or Ma Huang (Ephedra alkaloids)
High performance liquid
chromatography
Planta Medica 1988 pp. 69-70 (modified)
Guarana
(caffeine)
Gas chromatography
Journal of Food Science (modified), 48: 745-747, (1983)
Isflavones (soy, kudzu,
clover)
Gas chromatography
Seo, A. and Morr, C.V., "Improved High-Performance
Liquid Chromatographic Analysis of Phenolic Acids and
Isoflavonoids from Soybean Protein Products," J.
Agric. Food Chem., 32(3): pp 530-533, 1984
Kudzu
(isoflavones)
High performance liquid
chromatography
Seo, A. and Morr, C.V., "Improved High-Performance
Liquid Chromatographic Analysis of Phenolic Acids and
Isoflavonoids from Soybean Protein Products," J.
Agric. Food Chem., 32(3): pp 530-533, 1984
Anthocyannin
(bilberry, grape seed)
High performance liquid
chromatography
Clover
(isoflavones)
High performance liquid
chromatography
Seo, A. and Morr, C.V., "Improved High-Performance
Liquid Chromatographic Analysis of Phenolic Acids and
Isoflavonoids from Soybean Protein Products," J.
Agric. Food Chem., 32(3): pp 530-533, 1984
Dong
Quai (ferulic acid)
High performance liquid
chromatography
Hagerman, A.E., Nicholson, R.L., "High-Performance
Liquid Chromatographic Determination of Hydroxycinnamic
Acids in Maize Mesocotyl," Journal of Agricultural
and Food Chemistry, 30 (No. 6): 1098-1102, (1982), Modified
Echinacea
(cichoric and chlorogenic acid)
High performance liquid
chromatography
Economic and Medicinal Plant Research, Vol. 5, H. Wagner
and Norman Farnsworth Ed., Academic Press, 1991, p.253-321
Evening
Primrose Oil (linoleic acid & GLA)
Gas chromatography
American Oil Chemists' Society, 'Ce 1-62 Fatty Acid Composition
by Gas Chromatography' (modified), Official Methods and
Recommended Practices f the AOCS, Fifth Ed., American
Oil Chemists' Society, Champaign, IL (1997)
Feverfew
(parthenolide)
High performance liquid
chromatography
Ginkgo Bilob
| |
Ginkgoflavone
glycosides
High performance liquid
chromatography
Journal of Chromatography (modified), 605: 41-48 (1992) |
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Ginkgo
terpenoids
High performance liquid
chromatography
Journal of Chromatographic Science (modified), 36:
April (1998) |
Ginseng,
(ginsenosides)
Panax or Korean
High performance liquid chromatography
Journal of Chromatography, 736 (1996) 77-81
Siberian
High performance liquid chromatography
Chem. nat. compd. (English translation) vol. 28, no. 1,
July 1992, pp. 36-39
Grapes/Raisins
(tartaric acid) HPLC
High performance liquid
chromatography
Official Methods of Analysis of AOAC INTERNATIONAL (2000)
17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 986.13. (Modified)
Green
Tea (phenols & caffeine)
UV detection
Nettle
Root (phytosterols)
Gas chromatography
Official Methods of Analysis of AOAC INTERNATIONAL (2000)
17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 994.10. (Modified)
Pygeum
(beta-sitosterol)
Gas chromatography
Official Methods of Analysis of AOAC INTERNATIONAL (2000)
17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 994.10. (Modified)
Saw
Palmetto (phytosterols & fatty acids)
Gas chromatography
Official Methods of Analysis of AOAC INTERNATIONAL (2000)
17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 996.06. (Modified)
Valerian (valerenic acid)
High performance liquid
chromatography
Journal of Liquid Chromatography, 10: 643-653, (1987).
(Modified)
St.
John's Wort (hypericin, pseudohypericin)
High performance liquid
chromatography
High-Performance Liquid Chromatographic Determination
of the Biologically Principle Hypericin in Phytotherapeutic
Vegetable Extracts and Alcoholic Beverages," Journal
of Chromatography A, 731: 336-339, 1996
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Free
amino acid profile
Official Methods of Analysis
of AOAC INTERNATIONAL (2000) 17th Ed., AOAC INTERNATIONAL,
Gaithersburg, MD, USA, Official Method 982.30. (Modified)
Taurine
Hischenhuber, C., Deutsche
Lebensmittel-Rundschau , "High Performance Liquid
Chromatographic and Thin-Layer Chromatogrphic Determination
of Taurine in Infant Formulas", /84, JAHRG. /HEFT
4/1988. (Modified)
Stuart, J.D., Wilson, T.D., Hill, D.W., Walters, F.H.,
Feng, S.Y., "High Performance Liquid Chromatographic
Separation and Fluorescent Measurement of Taurine, a Key
Amino Acid", Journal of Liquid Chromatography, 2(6),
809-821 (1979)
Individual
amino acids (free-form)
Amino acid analyzer
Official Methods of Analysis of AOAC INTERNATIONAL (2002),
17th Edition, AOAC INTERNATIONAL, Gaithersburg, MD, USA
Official Method 982.30 (Modified)
Individual
amino acids (requiring hydrolysis)
Amino acid analyzer
Official Methods of Analysis of AOAC INTERNATIONAL (2000)
17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 982.30. (Modified)
Methionine
and cystine (performic acid hydrolysis)
Amino acid analyzer
Official Methods of Analysis of AOAC INTERNATIONAL (2000)
17th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official
Method 982.30. (Modified)
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Glycemic
Research Institute
601 Pennsylvania Avenue, Suite 900
Washington, D.C 33701
www.Glycemic.com
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