Lactose Monohydrate
CAS:63-42-3.
MF: C12H22O11 .
Item | Specifications | Results |
Characters | A white or almost while crystalline powder,freely but slowly soluble in water,practically insoluble in ethanol (96 per cent) | A white or almost while crystalline powder,freely but slowly soluble in water,practically insoluble in ethanol (96 per cent) |
Identification A | The sample IR spectrum corresponds to spectrum of Reference Standard | The sample IR spectrum corresponds to spectrum of Reference Standard |
Identification B | The principal spot in the chromatogram obtained with the test solution is similar in position,colour and size to the principal spot in the chromatogram obtained with reference solution (a) | The principal spot in the chromatogram obtained with the test solution is similar in position,colour and size to the principal spot in the chromatogram obtained with reference solution (a) |
Identification C | Positive | Positive |
Acidity or alkalinity | ≤0.4 ml | 0.2 ml |
Specific optical rotation | +54.4°~+55.9° | +55.1° |
Heavy metals | ≤5 ppm | <5 ppm |
Water | 4.5%~5.5% | 5.1% |
Sulphated ash | ≤0.1% | <0.1% |
Loss on drying | ≤1.0% | <1.0% |
Appearance of solution | The solution is clear and not more intensely coloured than reference solution BY7 | The solution is clear and less intensely coloured than reference solution BY7 |
Absorbance | ≤0.04(400nm) ≤0.25(210nm~220nm) ≤0.07(270nm~300nm) | <0.04(400nm) <0.25(210nm~220nm) <0.07(210nm~220nm) |
Total aerobic microbial count | ≤100CGU/g | <10CFU/g |
Escherichia coli | Absent/g | Absent/g |
Conclusion | The results conforms with BP2010 standards |
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