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D-??? MSDS

D-Mannitol

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? (1) ???? : ? ?? ? 2.0g ? ????? ? 2.6g? ??? ?? 30℃? ?? ??? ? 20mL? ??? ?? ??? ???? 15～30?? ????? ???? ?? ???? ?? ??? 25mL? ?? ? ?? ???? ???? ?? ?? ???? ??? ?, ＝+23～+25°??? ??.

??(2) ?? : ? ??? ???(1→10) 10mL? ???????? 0.5mL? ?? ?? pH? 5.0～8.0??? ??.

??(3) ??? : ? ?? 10g? ??? ??????? ?? ??? ?, ? ?? 0.01N ?? 2.0mL? ???? ? ????? ??.

??(4) ?? : ? ??? ?????? ?? ??? ?, ? ?? 4.0ppm ????? ??.

??(5) ??? : ? ?? 10g? ??? ??????? ?? ??? ?, ? ?? 0.01N ?? 2mL? ???? ? ????? ??.

??(6) ? : ? ?? 5.0g? ??? ??????? ?? ?????????????? ?? ??? ?, ? ?? 1.0ppm ????? ??.

??(7) ?? : ? ?? 5.0g? ??? ??????? ?? ?????????????? ?? ??? ?, ? ?? 2.0ppm ????? ??.

??(8) ???? : ? ?? ? 7g? ??? ?? 「D-???」? ???? (1)? ?? ??? ?, ???? ??? 50mg ????? ??.

??(9) ?? : ? ?? 2.1g? ??? ?? ??????? ?? ?? 0.1N ?? 40mL? ???? ?????? ???? ?? ??? 4?? ???? ???. ? ?? 400mL ???? ???? ? 10mL? ??????? ?? ?? ???? ?? ?? ?? 6N ?????????? ???? ?? ???? 50mL? ???? ??? ???? ?? ??? ??? ?????? ????. ????? ??? ??? ?, ???, ?????? ??? ?? 100℃?? 30?? ????. ??? ????? ??? ???? ?? ??? ? 10mL, ??? 10mL ? ??? 10mL? ??? ???? 100℃?? 1?? ??? ?, ???? ??? 50mg ????? ??.

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? (1) ? ??? ?? ???? ????? ?? ???, ????? ? ????? ?? ???.

??(2) ? ??? ??? 165～169℃??? ??.

??(3) ? ??? ???? ?? ??? ?, ??????? ??? ??? ??? ????.

??(4) ??????? 1mL? ????? ?? ?? ? ??? ???? 5??? ??? ?? ?????? ??. ??, ???? ? ??? ???? ??? ? 5??? ????. ? ?? 5N ???????? 5??? ???? ????? ??? ??? ??? ???? ??? ??? ???, ? ?? ??? ????? ????? ???? ???? ????? ????. ?? ? ?? 5N ????????? ???? ????? ??? ???? ??? ???? ??? ????.

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? ? ?? ? 1.5g? ??? ?? ?? ?? ??? 100mL? ?? 0.45μm ??? ??? ?? ?????? ??. ??, ?????? 0.5, 1.0, 1.5 ? 2.0g? ??? ?? ?? ??? 100mL??? ?? 0.45μm??? ??? ?? ?? ?????? ??.

??? ???? : ????? ? ???? 20μL?? ??? ?????? ?????????? ???? ??? ????? ???. 4?? ??????(g/100mL)? ?? ? ????? ?????? ???? ???? ??????? ???? ?? ?????(g/100mL)? ?? ?? ???? ?? ???? ??? ???.

A : ????? ?? ???? ?? ?????(g/100mL)

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?????????? ? : Aminex HPX 87C(?? ??) ?? ?? ??? ?

??????? ? ? : ?????(RI Detector)

?????????? : 85℃

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?????????? ? : 0.5mL/min

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? ? ?? 2g? ??? ????????? ?? ??? ?, ? ?? 0.1% ????? ??.

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Mannitol is a white, crystalline solid consisting of D-mannitol and a small quantity of sorbitol. It is odorless and has a sweet taste. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in most other common organic solvents. It is prepared commercially by catalytic reduction of glucose. Mannitol occurs in small amounts in a variety of foods such as olives, beets, and celery, and in the exudate of certain trees.

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ChEBI: D-mannitol is the D-enantiomer of mannitol. It has a role as an osmotic diuretic, a sweetening agent, an antiglaucoma drug, a metabolite, an allergen, a hapten, a food bulking agent, a food anticaking agent, a food humectant, a food stabiliser, a food thickening agent, an Escherichia coli metabolite and a member of compatible osmolytes.

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Mannitol may be extracted from the dried sap of manna and other natural sources by means of hot alcohol or other selective solvents. It is commercially produced by the catalytic or electrolytic reduction of monosaccharides such as mannose and glucose.

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Odorless white crystalline powder or free-flowing granules. Sweet taste.

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Water soluble.

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A sugar alcohol. More closely related to carbohydrates than to other polyhydric alcohols [Noller]. Flammable and/or toxic gases are generated by the combination with alkali metals, nitrides, strong reducing agents and strong oxidizing agents.

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Mildly toxic; mutagen.

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D-Mannitol is probably combustible.

Safety

Mannitol is a naturally occurring sugar alcohol found in animals and plants; it is present in small quantities in almost all vegetables. Laxative effects may occur if mannitol is consumed orally in large quantities.If it is used in foods as a bodying agent and daily ingestion of over 20g is foreseeable, the product label should bear the statement ‘excessive consumption may have a laxative effect’. After intravenous injection, mannitol is not metabolized to any appreciable extent and is minimally reabsorbed by the renal tubule, about 80% of a dose being excreted in the urine in 3 hours.
A number of adverse reactions to mannitol have been reported, primarily following the therapeutic use of 20% w/v aqueous intravenous infusions.The quantity of mannitol used as an excipient is considerably less than that used therapeutically and is consequently associated with a lower incidence of adverse reactions. However, allergic, hypersensitive-type reactions may occur when mannitol is used as an excipient.
An acceptable daily intake of mannitol has not been specified by the WHO since the amount consumed as a sweetening agent was not considered to represent a hazard to health.
LD₅₀ (mouse, IP): 14 g/kg
LD₅₀ (mouse, IV): 7.47 g/kg
LD₅₀ (mouse, oral): 22 g/kg
LD₅₀ (rat, IV): 9.69 g/kg
LD₅₀ (rat, oral): 13.5 g/kg

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Mannitol is stable in the dry state and in aqueous solutions. Solutions may be sterilized by filtration or by autoclaving and if necessary may be autoclaved repeatedly with no adverse physical or chemical effects.In solution, mannitol is not attacked by cold, dilute acids or alkalis, nor by atmospheric oxygen in the absence of catalysts. Mannitol does not undergo Maillard reactions.
The bulk material should be stored in a well-closed container in a cool, dry place.

Purification Methods

D-Mannitol is crystallised from EtOH, MeOH or H2O and dried at 100o. [Thomson Acta Chem Scand 6 270, 279, 280 1952, Beilstein 1 IV 2841.]

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Mannitol solutions, 20% w/v or stronger, may be salted out by potassium chloride or sodium chloride.Precipitation has been reported to occur when a 25% w/v mannitol solution was allowed to contact plastic.Sodium cephapirin at 2 mg/mL and 30 mg/mL concentration is incompatible with 20% w/v aqueous mannitol solution. Mannitol is incompatible with xylitol infusion and may form complexes with some metals such as aluminum, copper, and iron. Reducing sugar impurities in mannitol have been implicated in the oxidative degradation of a peptide in a lyophilized formation.Mannitol was found to reduce the oral bioavailability of cimetidine compared to sucrose.

Regulatory Status

GRAS listed. Accepted for use as a food additive in Europe. Included in the FDA Inactive Ingredients Database (IP, IM, IV, and SC injections; infusions; buccal, oral and sublingual tablets, powders and capsules; ophthalmic preparations; topical solutions). Included in nonparenteral and parenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Mon-medicinal Ingredients.

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