Lactose Monohydrate
» Lactose Monohydrate is a natural disaccharide, obtained from milk, which consists of one glucose and one galactose moiety. [noteLactose Monohydrate may be modified as to its physical characteristics. It may contain varying proportions of amorphous lactose.]
Packaging and storage
Preserve in tight containers.
Labeling
Where the labeling states the particle size distribution, it also indicates the d10, d50, and d90 values and the range for each. For modified Lactose Monohydrate, also label it to indicate the method of modification.
USP Reference standards
![]() ![]() USP Lactose Monohydrate RS. USP Sucrose RS. USP Fructose RS. USP Dextrose RS.
Clarity and color of solution
A solution of 1 g in 10 mL of boiling water is clear and nearly colorless. Determine the absorbance of this solution at a wavelength of 400 nm. The absorbance divided by the path length in centimeters is not more than 0.04.
Identification
B:
DiluentPrepare a mixture of methanol and water (3:2).
Developing solvent
Prepare a solution consisting of a mixture of ethylene dichloride, glacial acetic acid, methanol, and water (50:25:15:10).
Standard solution A
Prepare a solution of USP Lactose Monohydrate RS in Diluent having a known concentration of 0.5 mg per mL.
Standard solution B
Prepare a solution of USP Dextrose RS, USP Lactose Monohydrate RS, USP Fructose RS, and USP Sucrose RS in Diluent having a known concentration of 0.5 mg per mL for each Reference Standard.
Test solution
Transfer about 25 mg of Lactose Monohydrate to a 50-mL volumetric flask, dissolve in and dilute with Diluent to volume, and mix.
Procedure
Apply separately 2 µL each of Standard solution A, Standard solution B, and the Test solution to a thin-layer chromatographic plate (see Chromatography
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C:
Dissolve 250 mg in 5 mL of water. Add 3 mL of ammonium hydroxide, and heat in a water bath at 80
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Specific rotation
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Microbial enumeration tests
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Acidity or alkalinity
Dissolve 6 g by heating in 25 mL of carbon dioxide-free water, cool, and add 0.3 mL 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 red color.
Loss on drying
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Water, Method I
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Residue on ignition
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Heavy metals
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Protein and light-absorbing impurities
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Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 1264
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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