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Introduction
Lactose is a disaccharide sugar composed of galactose and glucose that is found in milk. Lactose makes up around 2–8% of milk (by weight), although the amount varies among species and individuals, and milk with a reduced amount of lactose also exists. It is extracted from sweet or sour whey. The name comes from lac (gen. lactis), the Latin word for milk, plus the -ose ending used to name sugars.It has a formula of C12H22O11 and the hydrate formula C12H22O11·H2O, making it an isomer of sucrose.
Application
1,what is the LACTOSE Monohydrate used for
Dry powder inhaler carrier; lyophilization aid; tablet binder; tablet and capsule diluent; tablet and capsule filler.
2,Lactose is widely used in pharmaceutical formulations as a filler and filler-binder in oral capsule and tablet formulations .
3,Lactose is also used in the manufacture of dry powder formulations for use as aqueous film-coating solutions or suspensions.
Specification
Item | Standard | Results |
Appearance | White crystalline granule or powder,odorless, tastessweet. | conforms |
Solubility | Soluble in water, but insoluble in ethanol,chloroform and ethylether. | conforms |
Special rotation | +52.3°~+52.6° | +52.3° |
Content (%) | 98.0~102.0 | 99.7 |
Moisture (%) | 4.5~5.5 | 5.0 |
Residue ignition (%) | ≤1.0 | 0.03 |
Loss on drying (%) | ≤1.0 | 0.11 |
Heavy metal (ppm) | ≤5 | conforms |
Arsenic(As) (%) | ≤0.0002 | conforms |
PH value | 4.0~7.0 | 4.8 |
Bacteria count | ≤1000/g | <10/g |
Mould count | ≤100/g | <10/kg |
Escherichia coli | Cannot be detected | conforms |