Lactose Monohydrate

Appearance: White free-flowing powder; Solubility: Freely but slowly soluble in water, practically insoluble in alcohol; Identification A: The retention of the main peak of the test solution in the chromatogram recorded under the content determination item should be consistent with the retention time of the main peak of the reference solution; Identification B: The infrared light absorption profile of the product should be consistent with that of the control; Optical Rotation: +54.4 +55.9; Acidity/Alkalinity: Take 6.0g of this product and check according to law, the solution is colourless, and not more than 0.4ml of 0.1 N sodium hydroxide is required to produce a pink to red colour; Clarity and Colour of Solution: Take 1.0g of this product, add 10ml boiling water to dissolve, check according to law, the solution should be clear and nearly colourless Take this product, determine according to law, measure absorbance at 400nm wavelength, not more than 0.04; Protein and impurity absorbance(210nm 220nm): Not more than 0.25; Protein and impurity absorbance(270nm 300nm): Not more than 0.07; Loss on Drying: Not more than 0.5%; Water: 4.5% 5.5%; Residue on Ignition: Not more than 0.1%; Heavy Metals: Not more than 5ppm; Arsenic Salt: Take the residue under the burning residue, check according to law, should comply with the regulations (0.0002%); Total Aerobic Microbial Count: Not more than 100CFU/g; Total Yeasts and Moulds Count: Not more than 50CFU/g; Escherichia coli: Negative/g; Content: The chemical name of this product is 4-O-beta-D-Galactopyranosyl-D-glucose. Containing C12H22O11 should be between 98.0% and 102.0%; Rotap Particle Size: Not less than 80% pass through 75m sieve Not less than 99% pass through 150m sieve