Lactose CAS No.:10039-26-6
Specification of Lactose Monohydrate
BP2009
| Items | Specifications | Results |
| Identification A | The infrared absorption spectrum of the sample is concordant with that of the standard | The infrared absorption of the sample was concordant with that of the 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 test is not valid unless the chromatogram obtained with reference solution(b) shows 4 clearly separated spots | The principal spot in the chromatogram obtained with the test solution was similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a). Reference solution (b) shows four clearly separated spots |
| Identification C | A red color develops | It appeared red color |
| Identification D | It complies with the test for water (see tests ) | It complied with the test for water |
| Appearance of solution | The solution is clear and not more intensely coloured than reference solution BY7 | The solution was clear and not more intensely coloured than reference solution BY7 |
| Acidity or alkalinity | Add 0.3 ml of phenolphthalein solution R. The solution is colourless. Not more than 0.4 ml of 0.1 N sodium hydroxide is required to change the colour of the indicator to pink | Add 0.3ml of phenolphthalein solution R: the solution was colorless, and 0.20mL of 0.1 N sodium hydroxide was required to change the colour of the indicator to pink |
| Specific optical rotation | +54.4°~+55.9°, calculated with reference to the anhydrous substance | +54.9° |
| Absorbance | The absorbance of the soluiton measured at 400nm is not greater than 0.04. Dilute 1.0ml of solution A to 10.0 ml with water R.Examine the solution from 210nm to 300nm. At wavelengths from 210nm to 220nm, the absorbance is not greater than 0.25. At wavelengths from 270nm to 300nm, te absorbance is not greater than 0.07 | The absorbance of the soluiton measured at 400nm is 0.012. Dilute 1.0ml of solution A to 10.0 ml with water R.Examine the solution from 210nm to 300nm. At wavelengths from 210nm to 220nm, the absorbance is less than 0.25. At wavelengths from 270nm to 300nm, te absorbance is less than 0.07 |
| Heavy metals | Not more than 5ppm | Less than 5ppm |
| Water | 4.5%~5.5% | 5.10% |
| Sulphated ash | Not more than 0.1% | 0.05% |
| TPC cfu/g | <100 | 20.00% |
| Escherichia coli/g | Absence | Not detected |
| Conclusion | The results can conforms with BP2009 | |