Alpha Lactose Monohydrate
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
(α-d-Lactose Monohydrate), C H O · H O 360.31—White powder. The β-d-lactose content is less than 3%.
Assay: Inject an appropriate derivatized specimen into a gas chromatograph (see Chromatography 〈621〉) equipped with a flame-ionization detector, helium being used as the carrier gas. The following conditions have been found suitable: a 0.25-mm × 30-m capillary column coated with a 1-μm layer of phase G2; the injection port temperature is maintained at 250°; the detector temperature is maintained at 280°; the column temperature is maintained at 230° and programmed to rise 4° per minute to 280°. The area of the C H O · H O peak is not less than 97% of the total peak area.
