Lactose Monohydrate

CAS NO. : 5989-81-1
Category： Lactose
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Product Description:

Product Name: Natural Crysta Lactose Monohydrate

Chemical Name: Lactose Monohydrate

CAS No.: 5989-81-1

MF:C₁₂H₂₂O₁₁^.H₂O

Appearance: Crystal powder

Description:

Lactose Monohydrate is a unique, excellent tasting sugar-free bulk sweetener. Because the same amount of Lactose Monohydrate is used in products as would be used if they were sweetened with sugar, Lactose Monohydrate-containing products have the same appearance and texture as those made with sugar.

Discovered in the 1960s, Lactose Monohydrate is made from sucrose and looks much like table sugar. It is white, crystalline and odorless. Lactose Monohydrate is a mixture of two disaccharide alcohols: gluco-mannitol and gluco-sorbitol.

Application:

Powder mixing, capsule / granule filling, pellet core, dry powder inhalation, wet granulation, premixing.

Specification:

Items	Standard
Identification A	The infrared absorption spectrum of the sample is concordant with that of the standard.
Identification B	The principal spot obtained from the Test solution corresponds in appearance and RF value to that obtained from Standard solution A.
Identification B	The test is not valid unless the chromatogram obtained with Standard solution B shows four clearly discernible spots, disregarding any spots at the origin.
Residue on ignition	Not more than 0.1%
Heavy metals	Not more than 5µg per g.
Clarity and color of solution	The solution(1g in 10ml of boiling water) isclear and nearly colorless.Determine the absorbance of this solution at a wavelength of 400 nm.The absorbance divided by the path length,in cm,is not more than 0.04.
Optical rotation	+54.4°~+55.9°, calculate on the anhydrous basis,determined at 20°
Acidity or alkalinity	Add 0.3ml of phenolphthalein TS: the solution is colorless, and not more than 0.4 ml of 0.1 N sodium hydroxide is required to produce a pink to red color.
Loss on drying	Dry a sample at 80° for 2 h. not more than 0.5%
Water	4.5%~5.5%
Protein and light-absorbing impurities	210-220 nm: Not more than 0.25 270-300 nm:Not more than 0.07
TAMC(cfu/g)	<100
Molds and Yeasts(cfu/g)	<50
Escherichia coli (/10g)	absence