Quality index: Appearance: white crystalline powder. Content: ≥ 98% Instruction: Betaine anhydrous is a chemical that occurs naturally in the body, and can also be found in foods such as beets, spinach, cereals, seafood, and wine. Betaine anhydrous is approved by the U.S. Food and Drug Administration (FDA) for treatment of high urine levels of a chemical called homocysteine (homocystinuria) in people with certain inherited disorders. High homocysteine levels are associated with heart disease, weak bones (osteoporosis), skeletal problems, and eye lens problems. Betaine anhydrous is also used for treating high blood homocysteine levels, liver disease, depression, osteoarthritis, congestive heart failure (CHF), and obesity; for boosting the immune system; and for improving athletic performance. It is also used for preventing noncancerous tumors in the colon (colorectal adenomas). Topically, betaine anhydrous is used as an ingredient in toothpastes to reduce the symptoms of dry mouth. Betaine in the anhydrous form is a white crystalline powder. Dissolution studies were omitted since it is freely soluble in water. It exists as anhydrous, monohydrate and hydrochloride forms. The applicant has justified its choice of the anhydrous form; the hydrochloride was discounted on organoleptic reasoning, and the monohydrate was not chosen due to poor flow properties of the compound. The applicant has discussed in detail the implications of formation of the monohydrate form, and the effect of humidity and high temperature on the product. Humidity conditions above 50% were found to have a negative impact on the powder with moisture absorbance and deliquescence observed. Consequently filling conditions are maintained below 40% humidity. The applicant has provided justification for a finished product consisting solely of the active, on the grounds that the drug substance has ideal flow characteristics, is freely soluble in water, has a low angle of repose and the quantity to be consumed by the patient (up to 20 g daily) and this is considered Packing: 25kg / bag or case, PE lining. Storage precautions: store in cool, dry and well ventilated warehouse. Uses: used in medicine, health food, diet food, etc. Annual capacity: 5000 tons / year