Lactose Monohydrate
Brief Introduction:
Lactose monohydrate is a hydrate with the chemical structural formula C12H22O11•H2O. It is a mixture of sucrose and lactose and has a variety of physiological activities and medicinal applications.
Lactose monohydrate is one of the main components of dairy products and one of the important energy sources for humans. After the human body ingests lactose monohydrate, it can be decomposed into glucose and fructose through the action of digestive enzymes, and further participates in the energy metabolism process.
Specifications:
| Test Items | Specifications |
| Appearance | White free-flowing powder |
| Solubility | Freely but slowly soluble in water, practically insoluble in alcohol |
| Identification | (1) The retention of the main peak of the test solution in the chromatogram recorded under the content determination item should be consistent with the retention time of the main peak of the reference solution. |
| (2) The infrared light absorption profile of the product should be consistent with that of the control. | |
| Optical Rotation | +54.4° ~ +55.9° |
| Acidity/Alkalinity | Take 6.0g of this product and check according to law, the solution is colourless, and not more than 0.4ml of 0.1 N sodium hydroxide is required to produce a pink to red colour. |
| Clarity and Colour of Solution | Take 1.0g of this product, add 10ml boiling water to dissolve, check according to law, the solution should be clear and nearly colourless. |
| Take this product, determine according to law, measure absorbance at 400nm wavelength, not more than 0.04 | |
| Protein and impurity absorbance | 210nm ~ 220nm: Not more than 0.25 |
| 270nm ~ 300nm: Not more than 0.07 | |
| Loss on Drying | Not more than 0.5% |
| Water | 4.5% ~ 5.5% |
| Residue on Ignition | Not more than 0.1% |
| Heavy Metals | Not more than 5ppm |
| Arsenic Salt | Take the residue under the burning residue, check according to law, should comply with the regulations (0.0002%). |
| Total Aerobic Microbial Count | Not more than 100CFU/g |
| Total Yeasts and Moulds Count | Not more than 50CFU/g |
| Escherichia coli | Negative/g |
| Content | The chemical name of this product is 4-O-beta-D-Galactopyranosyl-D-glucose. Containing C12H22O11 should be between 98.0% and 102.0%. |
| Rotap Particle Size | Not less than 80% pass through 75μm sieve |
| Not less than 99% pass through 150μm sieve |
Applications:
Lactose monohydrate is widely used as a filler and diluent in tablets and capsules, and as a diluent in powder inhalers. Lactose is added to lyophilized solutions to increase volume and aid in lyophilized mass formation.
Medicinal lactose is an excellent filling and binding new excipient. It can not only improve the hardness of tablets, increase wear resistance, make the appearance smooth and delicate, but also improve the intrinsic "dissolution" performance. It can especially promote bioavailability in the body for poorly soluble drugs.
Packaging:
1kg/aluminum foil bag, 25kg/paper-plastic composite bag.
Storage Conditions:
Preserved in unopened original containers in a cool dry place before using; kept away from direct sunlight, heat and moisture.
Shelf Life:
24 months if stored under above mentioned conditions.
