| Test items | Criterion | Results |
| Identification A | The infrared absorption spectrum of the sample is concordant with that of the standard. | The infrared absorption spectrum of the sample was 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 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. | Standard solution B shows four clearly discernible spots. |
| Identification C | A red color develops. | It appeared red color. |
| Specific rotation | +54.4°~+55.9°, calculate on the anhydrous basis. | +55.0° |
| 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 red color. | Add 0.3ml of phenolphthalein TS: the solution was colorless, and not more than 0.4 ml of 0.1 N sodium hydroxide was required to produce a red color. |
| Loss on drying | The monohydrate form loses not more than 0.5% of its weight, and the modified monohydrate form loses not more than 1.0% of its weight. | 0.02% |
| Water | 4.5%~5.5% | 5.0% |
| Residue on ignition | Not more than 0.1% | 0.04% |
| Heavy metals | The limit is 5µg per g. | Less than 5µg per g. |
| Protein and light-absorbing impurities | The absorbance divided by the path length in centimeters is not more than 0.25 in the range of 210 to 220nm and is not more than 0.07 in the range of 270 to 300nm. | The absorbance divided by the path length in centimeters was not more than 0.25 in the range of 210 to 220nm and was not more than 0.07 in the range of 270 to 300nm. |
| TPC | <100cfu/g | < 10cfu/g |
| Yeast & Mould | <50cfu/g | < 10cfu/g |
| Escherichia coli (/10g) | absence | Not detected |
| Conclusion : | The Quality of lactose product has the achieved scandard of USP30 after examination standard examination, and consequently meet the provision. |
China
