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Product Name: Lactose Monohydrate
CAS: 10039-26-6
MF: C12H24O12
MW:360.31
structural formula:
Appearance: White or almost white, crystalline powder.
Particle Size:60-200mesh
Solubility:
Freely but lowly soluble in water, practically insoluble in ethanol (96 per cent).
Used For: powder mixing, capsule / granule filling, pellet core, dry powder inhalation, wet granulation, premixing.
Test Item | Criterion |
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 | NMT 0.1% |
Heavy metals | NMT 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 NMT 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 ro red color. |
Loss on drying | Dry a sample at 80°for 2 h. NMT 0.5% |
Water | 4.5%~5.5% |
Protein and light-absorbing impurities | 210-220 nm: NMT 0.25 270-300 nm: NMT 0.07 |
TAMC(cfu/g) | <100 |
Molds and Yeasts(cfu/g) | <50 |
Escherichia coli. (/10g) | absence |
Product Name: Lactose Monohydrate
CAS: 10039-26-6
MF: C12H24O12
MW:360.31
structural formula:
Appearance: White or almost white, crystalline powder.
Particle Size:60-200mesh
Solubility:
Freely but lowly soluble in water, practically insoluble in ethanol (96 per cent).
Used For: powder mixing, capsule / granule filling, pellet core, dry powder inhalation, wet granulation, premixing.
Test Item | Criterion |
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 | NMT 0.1% |
Heavy metals | NMT 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 NMT 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 ro red color. |
Loss on drying | Dry a sample at 80°for 2 h. NMT 0.5% |
Water | 4.5%~5.5% |
Protein and light-absorbing impurities | 210-220 nm: NMT 0.25 270-300 nm: NMT 0.07 |
TAMC(cfu/g) | <100 |
Molds and Yeasts(cfu/g) | <50 |
Escherichia coli. (/10g) | absence |