Lactose Anhydrous Boiling Point: 397.76a C (Rough Estimate)

Appearance: White or almost white crystalline powder; Solubility: Freely but lowly soluble in water , practically insoluble in ethanol(96%); 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 5 g per g; Clarity and Colour of Solution: 1) The solution(1g in 10 ml of boiling water) is clear and nearly colourless. 2) Determine the absorbance of this solution at a wavelength of 400 nm. The absorbance divided by the path length , in cm , which is not more than 0.04; Optical Rotation: 54.4 +55.9 , calculated on the anhydrous basis , determined at 20; Acidity or alkalinity: Adding 0.3 ml of phenolphthalein TS: the solution is colourless , and not more than 0.4 ml of 0.1 N sodium hydroxide is required to produce a pink to red colour; Loss on Drying: Not more than 0.5% after drying a sample at 80 for 2 hours; Water: Less than 1.0%; Protein and light-absorbing impurities(210 nm 220 nm): Not more than 0.25; Protein and light-absorbing impurities(270 nm 300 nm): Not more than 0.07; Total Plate Count: Less than 100 CFU/g; Yeasts & Moulds: Less than 50 CFU/g; Escherichia coli: Negative/10g; Assay The chemical name of this product is O--D-galactopyranosyl-(14))--D-glucopyranos anhydrate. The content of C12H22O11 should be between 98.0% and 102.0%; Acidity: Taking 1.0 g of this product , and the pH value should be between 4.0 and 7.0.