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Maltose
مالتوز
1Nonproprietary names
- JPMaltose Hydrate
- USP–NFMaltose
2Synonyms and trade names
Malt sugar; maltobiose; maltose monohydrate; Advantose 100; Sunmalt
3Chemical name and CAS Registry Number
4-O-α-D-Glucopyranosyl-β-D-glucopyranose monohydrate · [69-79-4]
4Empirical formula and molecular weight
C12H22O11·H2O · 360.31
5Functional category
Sweetening agent
Typical concentrations: — · Dosage forms: Solid, Liquid
6Applications in pharmaceutical formulation
Used as a sweetener and as a tablet diluent and binder, including spray-dried grades for direct compression. It is used as a stabiliser and tonicity agent in some parenteral protein products (for example intravenous immunoglobulins), as a lyoprotectant in freeze-dried products, and as a carbohydrate source in some intravenous infusions.
7Description
White crystals or crystalline powder, odourless, with a mildly sweet taste; its sweetness is roughly a third of that of sucrose.
8Typical properties
- Melting point
- about 102–103 °C (monohydrate)
- Solubility
- freely soluble in water; very slightly soluble in ethanol; practically insoluble in ether
- Specific rotation
- about +126° to +131° (at equilibrium, anhydrous basis)
- Reducing sugar
- yes; solutions show mutarotation
9Stability and storage conditions
Stable when stored dry. Aqueous solutions show mutarotation and can support microbial growth. Store in a well-closed container in a cool, dry place.
10Incompatibilities
As a reducing sugar it can undergo Maillard reactions with primary and secondary amines, including amino acids and proteins (glycation). Incompatible with strong oxidising agents.
11Method of manufacture
Produced by enzymatic hydrolysis of starch with β-amylase (often with a debranching enzyme), followed by purification and crystallisation or spray drying.
12Safety
Hydrolysed to glucose and regarded as non-toxic. Important: parenteral maltose (for example in some immunoglobulin products) can give falsely high blood glucose readings with glucose-meter strips that use glucose dehydrogenase–pyrroloquinoline quinone (GDH-PQQ), which has led to inappropriate insulin dosing.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid generating dust; eye protection, gloves and a dust mask are recommended.
14Regulatory status
Monographs in the USP–NF and JP. Used in oral solid products and, in some countries, in parenteral protein formulations and infusions.
15Related substances
Lactose; maltitol; sucrose; trehalose; maltodextrin.
16Comments
For protein stabilisation, non-reducing sugars such as sucrose or trehalose avoid the glycation risk of maltose. Product labelling for maltose-containing parenterals should warn about interference with GDH-PQQ glucose monitoring.