Mannitol

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Mannitol is a hexanol with a sweet taste. Because of the absorption of heat during the dissolution, it has a comfortable feeling to the mouth, so it is widely used in the manufacture of chewable tablets such as antialcoholic medicine and mouth cooling agent. Mannitol granules are used as excipients for direct compression in tablets and Mannitol can be used as base materials for nitroglycerin tablets.

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Mannitol is a hexanol with a sweet taste. Because of the absorption of heat during the dissolution, it has a comfortable feeling to the mouth, so it is widely used in the manufacture of chewable tablets such as antialcoholic medicine and mouth cooling agent. Mannitol granules are used as excipients for direct compression in tablets and Mannitol can be used as base materials for nitroglycerin tablets.

Application

Mannitol is used as raw materials for large volume parenterals, to produce Mannitol Injection, which has the efficacy of reducing intracranial pressure, intraocular pressure and diuresis. As filler and excipient, Mannitol is used in tablets for Anticancer medicine, Antibacterial medicine, Antihistamines medicine, Vitamins, Antialcoholic medicine, Refreshing agent. As cerebral vasodilator, Mannitol is for the treatment of cerebral vascular infarction, As diuretics, Mannitol is a mild laxative, it has special effects on oliguria and renal function deline caused by edema and burns.

Mannitol Standard
ITEM	CP2015	BP2016	EP9.2	USP40
Appearance	white crystals or crystalline power,odorless
Solubility	Freely soluble in water,very slightly soluble in ethanol
Identification:Melting point	166~170℃	165~170℃	165~170℃
Specific optical rotation	+137°~+145°	+23°~+25°	——
Identification:FeCl3	Positive	——	——
Identification:Infrared absorption spectrophotometry	Conformity
Identification:TLC	——	Conformity	——
Acidity	Conformity	——	——
Appearance of solution	Clear and colourless
Related sugars	≤2.0%	Conformity	Conformity
Reducing sugars	≥12.8ml	≤0.1%
Chloride	≤0.003%	——
Sulphate	≤0.01%	——
Oxalate	≤0.02%	——
Loss on drying	≤0.5%	≤0.5%	≤0.5%
Residue on lgnition	≤0.1%	——
Heavy metals	≤10ppm	≤5ppm	——
Arsenic	≤2ppm	——	——
Conductivity	——	≤20us/cm	≤20us/cm
Nickel	——	≤1ppm	＜1ug/g
Assay	98.0~102.0%	97.0~102.0%	97.0~102.0%
Bacterial endotoxins	——	＜2.5cuf/g	＜2.5cuf/g
The total viable aerobic count	——	≤100us/cm	≤100us/cm
Molds and yeasts	——	≤100us/cm	≤100us/cm
Escherichia coli	——	Negative/g	Negative/g
Salmonella	——	Negative/10g	Negative/10g

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