Asai Germanium Basic Knowledge Q&A

"Asai Germanium" was invented in 1967 by a Japanese inventor Dr. Asai Kazuhiko with his belief and passion. "Asai Germanium" is world's first "water-soluble organic germanium" created by Dr. Asai's pioneer processing method. It is produced only by Asai Germanium Research Institute Co. and the crystal structure has been determined and reported on J.A.C.S.(Journal of the American Chemical Society).

Later then, Asai Germanium Research Institute and many Japanese universities including research institutes nationwide conducted tests on "safety" and "bio-activity", and reported about 200 "basic clinical research reports". With this background, organic germanium whose scientific basis has been confirmed as a raw material for foods and cosmetics is called "Asai Germanium".

Dr. Kazuhiko Asai

Dr. Asai's passion to "use my germanium for the health of people and for the well-being of humankind" has been continuously passed down, and even now Asai Germanium Research Institute is based on the latest scientific knowledge. In pursuit of new possibilities, new research challenges and results are being brought.

Asaigermanium will continue to be widely recognized as a prominent presence in health food materials, with new biodiversity and diverse bio-activity.

Dr. Asai Kazuhiko Ph.D., is a Japanese scientist and founder of Asai Germanium Research Institute and the creator of world's first water soluble organic germanium called "Asai Germanium". The research and development started in 1970, and had a firm belief and passion on scientific progress. He successfully invented Organic Germanium known as "Asai Germanium" which is the only organic germanium confirmed and approved with safety.

In Japan, only medicines are allowed to used word "cure for disease".
Since Asai-Germanium is not registered as a medicine, we are not allow to answer this question.

Inorganic Germanium corresponds to metallic germanium that is generally used for decorations such as bracelets, clothing, electronic industrial products, etc., and germanium dioxide that accumulates may cause health hazards.

Organic Germanium is a germanium compound that contains carbon (Ge-C bond) in the structure of the compound, but if you consider the combination of raw materials and the difference in the manufacturing method, there are hundreds of organic germanium compounds alone. Thousands are possible, all of which have different toxicity and bio-activity. Also, even for the same compound, the purity and impurities differ depending on the raw materials and manufacturing methods.
In recent years, it is known as a raw material for cosmetics and health foods.

"Asai Germanium" is an organic germanium that was created for the first time in the world by "Dr. Asai Kazuhiko" and is produced only at the Asai Germanium Research Institute. It is manufactured with a unique manufacturing method using extremely high-purity germanium as a raw material. Another method is to make it from germanium dioxide (GeO 2 ), but it is known that there are differences in the organic germanium crystals and impurities due to the difference in the manufacturing method. With regard to Asai Germanium, safety tests have been carried out, quality control methods have been established, and various actions have been confirmed, and research is still ongoing.

In the “voluntary inspection guidelines for safety of raw materials for foods such as tablets and capsules” by the Ministry of Health, Labor and Welfare Japan, in the case of a single compound, all of raw material, production method, and purity are the same. It is specified that the compound is equivalent only in case.

"Asai Germanium" is a unique organic compound that can be manufactured only by Asai Germanium Research Institute, because it is made by a unique method using a mass of germanium element with a purity of 99.9999% or more (poly-crystalline germanium) as a raw material. The crystal structure of germanium has been determined and reported. Therefore, if it is manufactured by the same method using the same poly-crystalline germanium as Asaigermanium as the raw material and if it is not of the same purity, it is not Asaigermanium, so the results of the safety test conducted at the Asai Germanium Research Institute Many research results cannot be applied.

Although Asaigermanium is a food ingredient, it is not a daily food-like vegetables or rice, but since it was first created in 1967 by Dr. Kazuhiko Asai in the world, it has been orally taken by many people during the 53 years and there has been no report of any problem.

Of course, scientifically, safety tests (GLP application tests and GCP compliance tests) are also conducted. Asaigermanium is an organic germanium that has been confirmed to be safe for both animals and humans.

The safety test of Asaigermanium is carried out under the guidelines of GLP (Good Laboratory Practice) application test and GCP (Good Clinical Practice) compliance test.

  • GLP application test 
    conducted at a test facility where the Ministry of Health, Labor and Welfare guarantees the reliability of equipment and test methods
  • GCP-compliant test
    test conducted in compliance with the law established for the purpose of conducting appropriate clinical trials to ensure the human rights and safety of test subjects and the reliability of clinical trial data.

Health foods can also be shaped like tablets and capsules like medicines, and it is necessary to ensure safety in the sense of preventing health damage due to excessive intake of health foods.

The Ministry of Health, Labor and Welfare Japan is instructing manufacturers to take responsibility for ensuring the safety of health foods. Therefore, an inspection method called "Voluntary inspection guideline on safety of raw materials for foods such as tablets and capsules" is shown, and "if the safety cannot be ensured based on eating experience, conduct toxicity test using raw materials, etc." (GLP application test) ”.

In addition to the repeated dose toxicity test (* 1) and in vitro genotoxicity test (* 2) specified in the "Voluntary inspection guidelines for the safety of raw materials for foods such as tablets and capsules," Asaigermanium is as follows, conducting various tests.

  • 1. Acute toxicity: Single-dose toxicity test
    Test in which a large amount of a single dose of a test substance is administered to mammals, and then changes in general conditions are observed as the main indicators to elucidate the toxicity of the test substance both qualitatively and quantitatively. . It also serves as the basis for setting doses for repeated administration.
  • 2. Sub-acute / chronic toxicity: Repeated dose toxicity test (1 to 12 months) * 1
    Test to determine the toxicity changes that occur when a test substance is repeatedly administered to mammals in relation to dose and time.
  • 3. Teratogenicity: Reproductive and developmental toxicity test
    Test to determine whether application of the test substance to the living body induces any adverse effects in the process of reproductive development.
  • 4. Antigenicity: Antigenicity test * 1
    Test in which a test substance is administered to animals (rodents) to check the strength of antibody reactions such as allergic reactions.
  • 5. Genotoxicity: 3 types of mutagenicity tests * 2
    (1) A test to determine whether or not a test substance induces gene mutation in bacteria.
    (2) A test that examines whether or not the test substance induces an abnormality of the chromosome (carrier of genetic information) using cultured mammalian cells.
    (3) A test in which a test substance is administered to rodents such as mice, and the inducibility of chromosome (carrier of genetic information) abnormalities in cells of bone marrow or peripheral blood (using micro-nucleus as an index) is examined.
  • 6. Skin irritation: Skin irritation test (single and 2-week cumulative)
    To predict the extent of skin reaction (injury) such as erythema, edema, and desquamation caused by single or repeated contact of the test substance with the skin. test.
  • 7. Skin sensitization: Skin sensitization test
    Induction of a specific immune system caused by repeated contact of the test substance with the skin and subsequent single contact with the test substance, and the resulting skin such as erythema, edema, and scaling. A test for predicting the degree of reaction induction (induction).
  • 8. Phototoxicity: Phototoxicity test
    A test for predicting the degree of skin reaction such as erythema, edema, and desquamation caused by a stimulant changed by photo-excitation when a test substance is contacted with the skin once under UV irradiation.
  • 9. Photo-sensitization test
    Inducing a specific immune system by repeatedly contacting the test substance with the skin under UV irradiation and then contacting the test substance once under UV irradiation, and its A test to predict the presence and extent of skin reactions such as erythema, edema, and desquamation depending on the results.
  • 10. Eye irritation: Eye mucous membrane irritation test
    Predicts irritation to mucous membranes, conjunctiva, iris, and cornea that occur when humans accidentally put the test substance into the eye by directly contacting the test substance with the eye Test to do.
  • 11. Human patch test * 2
    test in which the test substance is occluded and applied to the upper back of the human, or the upper arm or forearm, and the degree of skin reaction caused by the primary or, in some cases, sensitization of the test substance is confirmed.

(Quoted / explained from “Guidelines for non-clinical drug testing 1997/2002” and “Guidelines for safety evaluation of cosmetics 2001”)

Both tests are GLP applicable tests carried out by the Ministry of Health, Labor and Welfare Japan at test facilities that guarantee the reliability of the facilities and test methods (* 1: non-GLP applicable test, * 2: GCP compliant test).

As a result of the 1st to 5th tests, Asaigermanium showed a homeostatic maintenance reaction at low and medium doses by oral administration, and caused loose stools and diarrhea by the large dose of 100 to 200 times or more of the usual dose. The secondary changes were the decrease in body weight and food intake, and changes in the digestive tract, etc., but no other toxicity was observed and it was presumed that the compound is highly safe. As a cosmetic ingredient, 6 to 11 tests have been conducted, and it has been confirmed that it is safe for the skin as well (it is shown as Repagermanium in the cosmetic ingredient label).

The Asai Germanium that enters the body dissolves in water and travels to the inside of the body, and acts on cells throughout the body while traveling around the body. During that time, it retains its original chemical structure of Asaigermanium and is rapidly excreted from urine and feces within 24-72 hours.

It has been confirmed in many experiments and research that Asaigermanium is not accumulated in all organs in the body, and it works well in the body without changing its shape, and is excreted outside the body as is.

A large misunderstanding of the health hazard caused by the sale of inorganic germanium (GeO2) labeled as an organic germanium compound (carboxyethyl germanium sesquioxide) in germanium products.

Around 1980, health foods made of germanium, mainly beverages, began to be sold from pharmacies and so on, and it became popular. Initially, only organic germanium products were available, but from around 1981, products of germanium dioxide (GeO2) and products of organic germanium mixed with germanium dioxide came to be sold, and by taking germanium dioxide, kidney damage occured. There were also those who died from developing neurological disorders.

The paper that had a great influence, including the medical community, was Okuda's paper published in 1987. It was reported that two patients who took a health food labeled as "carboxyethyl germanium sesquioxide", which indicates organic germanium, developed renal dysfunction.

However, Okuda et al. Reported in another paper in 1990 that they were germanium dioxide (GeO2) as a result of analyzing the health food taken by two cases of the 1987 paper. In addition, as a result of conducting a new animal experiment, no toxicity such as renal dysfunction was observed even when the organogermanium "carboxyethylgermanium sesquioxide" provided by Asai Germanium Research Institute was administered to rats. It was accurately reported that germanium (GeO2) had obvious renal damage. In other words, the error that "health foods that caused health problems in the 1987 article was labeled as" carboxyethyl germanium sesquioxide ", but the content was actually germanium dioxide (GeO2)" was corrected. That's why.

In addition, at the same time, the Ministry of Health and Welfare Japan at that time urgently established the "Experts' Meeting on Germanium in Foods" and was considering it. As a result, according to the notification of the Director General of the Public Health Bureau of October 21, 1988, “Handling of foods containing germanium”, “These renal impairments are due to germanium dioxide (GeO2). When using as a raw material for food, be sure to confirm the safety of its long-term health effects before using it. ”

As a result, the health hazard due to germanium dioxide (GeO2) was rapidly reduced. However, despite the fact that the cause of the health hazard of germanium foods at the time was toxicity due to germanium dioxide, the false information that "germanium is dangerous" spread as general recognition. The social consequences have remained to a considerable extent.

However, as you can see from the germanium-related safety information published by some public institutions, there is no toxicity information about organic germanium (Asaigermanium) at present. Regarding the safety of organic germanium, it seems that socially correct information has taken root.

Of course, the organic germanium used in our products is "Asaigermanium", and its safety has been confirmed as described above in [Safety Confirmation Test] and [Absorption / Distribution / Metabolism / Excretion].

If the starting materials are not good, no matter how hard you try, you cannot do anything.
Asaigermanium is made from rare and precious germanium, which is made of germanium metal (high-quality poly-crystalline germanium) with a purity of 99.9999% or more called 6-nine.

Quality checks are performed at each stage of the germanium metal refining process, and it is clearly confirmed that no impurities are detected in the manufactured germanium, that is, below the measurement limit (0.0001%).

It is a notation when the numerical value of the actually detected range is shown accurately.
In the case of 99.9999%, it means that impurities were not recognized up to that value by the proof that the purity was measured to the 0.0001 place. It is a proof of trust that we measure the purity down to a small value because the value is fine.
99.9999% refers to the state where 6 9 are lined up, and is called 6 nines. This means that the condition is infinitely close to 100%.

The Asai Germanium Research Institute manages manufacturing and quality according to its own standards in accordance with GMP. From the check of raw materials, the progress in each process is confirmed. Manufactured in a clean room with high cleanliness, all processes are computer controlled.

Even for the compounds represented by the same chemical formula, if the starting materials and manufacturing methods are different, the crystal structure, purity, residual impurities, and safety will also be different. It is a very important management system to maintain the high quality of Asaigermanium.

Asai germanium is manufactured according to the GMP standard guidelines at the factory of Asai Germanium Research Institute.

GMP is an acronym for "Good Manufacturing Practice," which manufacturing process control to ensure that products are manufactured "safely" and that "constant quality" is maintained at all stages, from receiving raw materials to manufacturing and shipping is as per standard.
The Ministry of Health, Labor and Welfare Japan obliges manufacturers to enforce GMP for pharmaceuticals, and for health foods, since the number of health foods with a shape very similar to that of medicines has increased, manufacturers have recommended the acquisition of GMP from 2005, and the certification system.

At Asai Germanium Research Institute, the manufacturing department produces Asaigermanium in a closed device that is operated by a computer and in a clean room that is strictly controlled.  The quality control department inspects more than 20 items at each stage and in each lot, which is always carried out to maintain Asai germanium in the highest quality.

Only organic germanium manufactured at Asai Germanium Research Institute can be called "Asaigermanium".
For organic germanium other than Asaigermanium, it is not possible to apply the results of safety tests conducted at the Asai Germanium Research Institute or the results of numerous studies.ASAI GERMANIUM®

The Asaigermanium logo mark on the left can be attached only to products that use Asaigermanium. It is a proof that this mark is Asai germanium.

Three iconic spheres that are largely arranged in the logo mark. These represent the three elements that underpin the Asaigermanium : " green ... germanium atom ", " red ... oxygen atom ", and " blue ... carbon atom ".
Furthermore, the letter "A" appears above each sphere, representing the "A" of "Asigermanium".
It shows that it is also the "A" (three "A"), which means the highest rank.
This logo mark is a mark of trust that can only be attached to "Asai Germanium-containing products manufactured at the Asai Germanium Research Institute, Ltd.".

The Asaigermanium (Asai-Germanium) has resulted from over 53 years of research, testing and dedication, which made Asaigermanium products to an exceptionally safe and high-standard for human health. To avoid risk of fake product, always buy Asaigermanium products from reliable sources.

Counterfeit Asaigermanium products are fake products. It may be contaminated or contain the wrong or no active ingredient.
Counterfeit Asaigermanium products may be harmful to your health. They can also cause serious or even fatal injuries.

Since 1967, many safety tests are conducted on Asaigermanium products, manufactured by Asai Germanium Research Laboratories.  The safety of organic germanium manufactured by other manufacturers is not confirmed. In addition, ensure this logo mark is displayed on products using Asaigermanium products manufactured by Asai Germanium Research Laboratories.

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