Lactose Monohydrate /Lactose anhydrous
CAS No.: 63-42-3/64044-51-5/5989-81-1/10039-26-6
Product Name: Lactose Monohydrate
CAS#10039-26-6
Spec: pharma grade
Package: 25kg/bag, 14mt/20`FCL on pallets
Delivery time: in stock for prompt shipment.
Dangerous goods or not: Not
Country of origin: China
CAS#10039-26-6
Spec: pharma grade
Package: 25kg/bag, 14mt/20`FCL on pallets
Delivery time: in stock for prompt shipment.
Dangerous goods or not: Not
Country of origin: China
Description
Spec of Lactose Monohydrate:
| Items | Specification |
| Appearance | White or almost white, crystalline powder, |
| Solubility | Freely but lowly soluble in water, practically insoluble in ethanol (96 per cent). |
| Identification A | The infrared absorption spectra of the sample are consistent with those 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 | NMT 0.1% |
| Heavy metals | NMT 5rg per g. |
| Clarity and color of solution | The solution(1g in 10ml of boiling water) is clear 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 NMT0.04 |
| Optical rotation | +54.4°~+55.9°,calculate on the anhydrous basis, determined at 209 |
| Acidity or alkalinity | Add 0.3ml of phenolphthalein TS: the solution is colorless, and not more than 0.4ml of 0.1 N sodium hydroxide is required to produce a pink ro red color. |
| Loss on drying | Dry a sample at 80° for 2 h.NMT 0.5% |
| Water | 4.5%~5.5% |
| Protein and light-absorbing impurities |
210-220 nm: NMT 0.25 270-300 nm: NMT 0.07 |
| TAMC(cfu/g) | <100 |
| Molds and Yeasts(cfu/g) | <50 |
| Escherichia coli. (/10g) | absence |
