| ≥1 piece |
| Product Name: Lactose Monohydrate | |
|
Type: Food Additives/Pharmaceutical Excipient Origin: China CAS No.: 64044-51-5 AUCO No.: 919 Packing: 25kg bag |
| Items | Standard |
| 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 | Not more than 0.1% |
| Heavy metals | Not more than 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 not more than 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 to red color. |
| Loss on drying | Dry a sample at 80° for 2 h. not more than 0.5% |
| Water | 4.5%~5.5% |
| Protein and light-absorbing impurities | 210-220 nm:Not more than 0.25 270-300 nm:Not more than 0.07 |
| TAMC(cfu/g) | <100 |
| Molds and Yeasts(cfu/g) | <50 |
| Escherichia coli (/10g) | absence |