Lactose Monohydrate
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Lactose Monohydrate

Type: Food Additives/Pharmaceutical Excipient
Origin: China
CAS No.: 64044-51-5
AUCO No.: 919
Packing: 25kg bag
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Lactose Monohydrate

Lactose monohydrate, CAS NO. is: 64044-51-5. It is widely used in food and pharma processing, owing to its stable crystalline form, good solubility and sweetness.


Applications:

Food grade: Lactose food grade is a high-quality sweetener with a sweetness similar to sucrose, which increases the taste and flavor of food. It also has flavoring and stabilizing properties. At the same time, lactose food grade also has moisturizing and anti-crystallization effects, which can improve the texture and taste of food and extend the shelf life of food. 


Pharmaceutical grade: Lactose monohydrate is widely used as a filler and diluent in tablets and gels. Lactose is added to the freeze-dried solution to increase the volume and aid in the formation of freeze-dried lumps. It plays a very important role in pharma industry.


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.
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


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