Product Brief Introduction
Product name: Lactose Monhydrate
CAS: 10039-26-6
MF: C12H22O11
MW: 342.30
Product Specification
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Appearance |
White to off-whiter crystalline particle or powder |
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Identification |
IR: the infrared absorption spectrum of the sample complies with the reference standard. |
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HPLC: the retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
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In addition to the solvent peak in the chromatogram of the test product solution, if impurity peak is displayed, the sum of each impurity peak area shall not be greater than the peak area of the control solution 0.5 times(0.5%). |
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Protein and Impurity |
Absorbance(400nm wavelength) ≤ 0.04 |
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Absorbance (210~220nm) ≤ 0.25 |
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Absorbance(270~300nm) ≤ 0.07 |
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Solubility |
Soluble in water, insoluble in ethanol, trichloromethane or diethyl ether. |
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Specific Rotation |
+54.4°~ +55.9° |
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Acidity/Alkalinity |
Take 1.0g of this product, add 10ml boiling water to dissolve, compare to the standards, the solution should be clear. If it is turbid, compare it with No.1 turbidity standard solution, and do not be thicker. |
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Moisture |
4.5% ~ 5.5% |
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Loss on Drying (80℃, 2hours) |
≤ 1.0% |
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Residue on Ignition |
≤ 0.1% |
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Heavy Metals |
≤ 5.0ppm |
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Arsenic |
≤ 2.0ppm |
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Total Plate Count |
≤ 1000cfu/g |
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Yeasts & Molds |
≤ 100cfu/g |
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E.Coli |
Negative/g |
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Particle Size |
75μm ≥80.0% |
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|
150μm ≥99.0% |
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Content |
98.0% ~ 102.0% |
