Chemical Properties

Maltose occurs as white crystals or as a crystalline powder. It is odorless and has a sweet taste approximately 30% that of sucrose.

Originator

Maltos-10 ,Otsuka ,Japan ,1974

Occurrence

Maltose also is formed by yeast during breadmaking.

Uses

Maltose is used as a nutrient, sweetener, and culture medium.

Definition

The most common reducing disaccharide, composed of two molecules of glucose. Found in starch and glycogen.

Production Methods

Maltose monohydrate is prepared by the enzymatic degradation of starch.

Manufacturing Process

The process of manufacturing a maltose product from a suitably purified starch source includes preparing an aqueous starchy suspension, adjusting the acidity thereof to from 4.6 to 6.0 pH, liquefying the suspension by heating in the presence of a diastatic agent, diastatically saccharifying the liquefied mixture, filtering, and concentrating the liquid to a syrup.

Pharmaceutical Applications

Maltose is a disaccharide carbohydrate widely used in foods and pharmaceuticals. In parenteral products, maltose may be used as a source of sugar, particularly for diabetic patients. Crystalline maltose is used as a direct-compression tablet excipient in chewable and nonchewable tablets.

Safety Profile

Experimental teratogenic and reproductive effects. Questionable carcinogen with experimental tumorigenic data. When heated to decomposition it emits acrid smoke and irritating fumes.

Safety

Maltose is used in oral and parenteral pharmaceutical formulations and is generally regarded as an essentially nontoxic and nonirritant material. However, there has been a single report of a liver transplantation patient with renal failure who developed hyponatremia following intravenous infusion of normal immunoglobulin in 10% maltose. The effect, which recurred on each of four successive infusions, resembled that of hyperglycemia and was thought to be due to accumulation of maltose and other osmotically active metabolites in the extracellular fluid. LD50 (mouse, IV): 26.8 g/kg LD50 (mouse, SC): 38.6 g/kg LD50 (rabbit, IV): 25.2 g/kg LD50 (rat, IP): 30.6 g/kg LD50 (rat, IV): 15.3 g/kg LD50 (rat, oral): 34.8 g/kg

storage

Maltose should be stored in a well-closed container in a cool, dry place.

Incompatibilities

Maltose may react with oxidizing agents. A Maillard-type reaction may occur between maltose and compounds with a primary amine group, e.g. glycine, to form brown-colored products.

Regulatory Status

In the USA, maltose is considered as a food by the FDA and is therefore not subject to food additive and GRAS regulations. Included in the FDA Inactive Ingredients Database (oral solutions). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in parenteral products available in a number of countries worldwide.

Who Evaluation

Evaluation year: 1997