Maltodextrin BP
Maltodextrin BP is a white or nearly white, free-flowing, hygroscopic powder obtained by the partial hydrolysis of starch, typically from corn, wheat, or rice. It consists of glucose polymers of varying chain lengths and is classified based on its dextrose equivalent (DE), generally below 20. In pharmaceutical applications, Maltodextrin is widely used as a filler, binder, stabilizer, and carrier in tablets, capsules, and powders for reconstitution. It is also used in oral nutritional supplements and controlled-release formulations due to its excellent solubility, bland taste, and compatibility with active pharmaceutical ingredients. The British Pharmacopoeia (BP) sets quality standards to ensure its safety and performance in medicinal use.

British Pharmacopoeia (BP) Specification for Maltodextrin

• Description: White or almost white, free-flowing powder; odorless or almost odorless; slightly sweet or practically tasteless.
• Solubility: Freely soluble in water; practically insoluble in ethanol (96%).
• Identification:
• Chemical Tests: Confirms presence of glucose polymers.
• Infrared Spectroscopy: Matches standard spectrum.
• Appearance of Solution: Clear and not more intensely colored than reference solution Y6 (typically 10% w/v solution).
• pH (10% solution): Typically between 4.5 and 7.0.
• Loss on Drying: Not more than 6.0%.
• Sulphated Ash: Not more than 0.6%.
• Dextrose Equivalent (DE): Typically <20, as specified by manufacturer or usage.
• Heavy Metals: Not more than 5 ppm.
• Microbial Contamination:
• Total aerobic microbial count: ≤1000 CFU/g
• Total combined yeasts/moulds count: ≤100 CFU/g
• Escherichia coli and Salmonella: Absent in specified amount.