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Maltose Excipient | Uses, Suppliers, and Specifications

Maltose, also known as maltobiose or malt sugar, is a naturally-occurring disaccharide formed from two units of glucose. It occurs naturally in germinating seeds, and can also be obtained through the enzymatic hydrolysis of Starch. Pharmaceutical grade Maltose is available as white crystals or as a crystalline, odourless, sweet-tasting powder.

Pharmacopoeial Compliance: USP-NF; J.P.E

Synonyms and Trade Names: Maltose; Maltose Hydrate; 4-O-α-D-glucopyranosyl-β-D-glucose; 4-(α-D-glucosido)-D-glucose; Malt Sugar; Maltobiose;  Advantose® 100; Finetose®; Maltose® HH; Sunmalt®

Uses and Applications: Tablet Diluent; and Sweetening Agent

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Description

Maltose (IUPAC name: 4-O-(α-d-glucopyranosyl)-β-d-glucopyranose) is a disaccharide pharmaceutical excipient consisting of two molecules of Glucose linked by an α-(1,4′) glycosidic bond. It occurs naturally in germinating seeds, hence the alternative names, Malt sugar and Maltibiose.

Maltose is believed to have been first discovered by the French chemist, Augustin-Pierre Dubrunfaut (1797-1881) and later confirmed by the Irish chemist, Cornelius O’Sullivan in 1872. The main difference between Maltose and other sweet disaccharides is that the glycosidic oxygen atom of one glucose is αand is bonded to the C-4 atom of another glucose unit which is the aglycone. This is what makes Maltose an α-1,4ʹ-glycoside.

Commercially, Maltose is obtained through hydrolysis of Starch that has been treated with barley malt catalysed by the enzyme amylase. The obtained material crystallises as the monohydrate and forms colourless to white crystals similar to other sweet carbohydrates. It is odourless and mildly sweet (approximately 30% the sweetness of Sucrose).

Chemical Structure & Identifiers


Chemical Name 4-O-α-D-Glucopyranosyl-D-Glucopyranose
Molecular weight 342.30 g/mol (Anhydrous)

360.31 g/mol (Monohydrate)

CAS Registration Number [69-79-4] (Anhydrous)

[6363-53-7] (Monohydrate)

Empirical Formula C12H22O11K (Anhydrous)

C12H22O11 H2O (Monohydrate)

EC Number 613-294-6
UNII Code (FDA) XJ659RV06F

Regulatory Status

Maltose is an approved pharmaceutical excipient. It is listed in the USP-NF and included in the US FDA Inactive Ingredients Database (covering tablets and oral solutions). In the USA, Maltose is classified as a food by the US FDA and is thus not administered under food additive and GRAS regulations.

Physicochemical Properties

Form Solid, powder
Appearance  
pH 4.5- 6.5 (10% w/v aqueous solution)
Angle of repose 37.10 (Advantose® 100)
Bulk density 0.67-0.72 g/ml
Tapped density 0.73-0.81 g/ml
Dissociation constant pKa = 12.05 (21 oC)
Flashpoint >149 oC
Flowability (Carr compressibility index) 18%
Melting point 102-103 oC (monohydrate)
Particle size distribution 20-300 µm

Pharmacopeoeal Specifications

  JP XV USP32-NF27
Name Maltose Maltose
Authorised used Excipient Excipient
Characters specified specified
Identification specified specified
Specific rotation +1260 to +1310 n/a
pH 4.5 -6.5
For anhydrous n/a 3.7 -4.7
For monohydrate n/a 4.0 -5.5
Clarity and colour of solution + n/a
Chloride ≤ 0.018% n/a
Sulfate ≤ 0.024% n/a
Heavy metals ≤ 4 ppm ≤ 5µg/g
Arsenic ≤ 1.3 ppm n/a
Dextrin, soluble starch and sulfite specified specified
Nitrogen ≤ 0.01% n/a
Related substances specified n/a
Loss on drying ≤ 0.5% n/a
Water n/a n/a
For anhydrous n/a ≤ 1.5%
For monohydrate n/a 4.5 -6.5%
Residue on ignition ≤ 0.1% ≤ 0.05%
Assay + n/a
Labelling n/a n/a

Key: n/a Specification is not listed

*All claims with respect to conformity are subject to our Terms and Conditions. No express or implied warranty is made for specific properties or fitness for any particular application or purpose.

Applications in Pharmaceutical Formulations or Technology

Maltose is widely used in the food sectors (baked goods, soft drinks, sweets, alcoholic drinks, and infant formula) as a bulking agent and diluent. It does not possess the sweetness of Sucrose and thus, is not used as a sweetener. A major user of Maltose is the brewing industry (to produce beer) and industrial production of alcohol.

In the pharmaceutical industry, Maltose can be used as a substitute for Lactose (Lactose monohydrate or Anhydrous lactose) since it possesses similar compaction properties. In parenteral products, Maltose can also be used as a source of glucose. Crystalline Maltose has been promoted for use as a direct compression tablet excipient (for instance, in chewable and nonchewable tablets).

Maltose is used to produce Maltitol which is itself used as a sugar substitute.

Safety and Precautions

Maltose occurs naturally in germinating seeds and is broken down for use as a nutrient. Maltose has been used in oral and parenteral pharmaceutical formulations for several decades. It is generally considered a nontoxic and nonirritant excipient.

Toxicology: LD50 (rat, IV): 15.3g/kg; LD50 (rat, oral): 34.8 g/kg

Stability and Storage Conditions

Maltose is a stable material with low hygroscopicity. The assigned shelf life is 24-36 months. The bulk material should however be stored in a well-closed container in a cool, dry place. When processing bulk Maltose, observance of established SHEQ protocols is highly recommended to prevent irritation of airways, the eyes and skin.

Sustainability and Environmental Impact

A sustainability score for Maltose is not yet available. However, this material is obtained from non-critical plant sources. The breakdown products do not pose a threat to ecology or marine life.

Manufacturers & Suppliers

SPI Pharma 

  • Advantose® – Maltose

Hayashibara/Nagase Co. Ltd

  • Maltose-PH – Maltose
  • Sunmalt-S – Maltose

Pfanstiehl Inc

  • Maltose

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References and Literature Used

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