CAS NO:[63-42-3]
Molecular formula:C12H22O11
Molecular weight: 342.30 (anhydrous).
Anhydrous lactose USP/NF, BP: anhydrous lactose widely used for direct tablet pressing. Excellent tablet strength can be obtained. Moreover, since anhydrous lactose has higher inherent solubility than lactose monohydrate, it can improve the stability and dispersion of water sensitive active components of drugs. The direct tablet pressing method with anhydrous lactose as filler can simplify the production process of drugs and eliminate the adverse effects of wet granulation on the stability of products caused by yellow core color and increase of related substances. Some data show that the stability of the sample is investigated through accelerated and long-term stability test, and the clinical efficacy of the sample is investigated through bioequivalence test. The drug produced by using anhydrous lactose as the auxiliary material of direct tablet pressing has stable quality and reliable curative effect.
At present, the specifications of anhydrous lactose in our company are: 80 mesh and 200 mesh