Description

D-Lactose Monohydrate is a high-purity, crystalline sugar derived from milk and a critical excipient in pharmaceutical manufacturing. Its primary value lies in its excellent compressibility, flow properties, and inert nature, making it an ideal carrier and filler for solid dosage forms. This product is essential for industries requiring reliable and consistent raw materials, particularly in pharmaceutical tablet production, food processing as a sweetener or texturizer, and microbiology as a culture medium component. D-Lactose Monohydrate CAS NO 64044-51-5 is supplied to meet the stringent quality standards demanded by these applications.

Application

• Pharmaceutical Excipient: A primary diluent and binder in direct compression and wet granulation processes for tablet and capsule manufacturing.
• Food & Beverage Ingredient: Used as a sweetener, bulking agent, and crystallization modifier in confectionery, baked goods, and infant formula.
• Microbiological Culture Medium: Serves as a fermentable carbohydrate source in the preparation of microbial growth media for laboratory and industrial fermentation.
• Animal Feed Supplement: Incorporated into feed formulations as a digestible energy source for livestock.
• Carrier for Dry Powder Inhalers (DPI): Acts as an inert carrier particle for active pharmaceutical ingredients in inhaled drug formulations.
• Industrial Fermentation: Functions as a substrate in fermentation processes for the production of lactic acid, antibiotics, and other biochemicals.

Basic Information

Product Name	D-Lactose Monohydrate
CAS No.	64044-51-5
Molecular Formula	C12H22O11 · H2O
Molecular Weight	360.31 g/mol
Synonyms	4-O-β-D-Galactopyranosyl-D-glucose monohydrate; Lactose monohydrate; Milk sugar; Saccharum lactis; D-(+)-Lactose monohydrate; Anhydrous lactose (when dehydrated); Fast-Flo lactose (trade name); Tabletose (trade name)
EINECS	200-559-2

Quality Control

Our D-Lactose Monohydrate is manufactured and tested to meet stringent pharmacopeial standards, including USP-NF and Ph. Eur. specifications. Each batch undergoes rigorous analytical testing for identity, purity, assay, and specific impurities to ensure consistent performance as a pharmaceutical excipient. A comprehensive Certificate of Analysis (COA) documenting all test results is provided with every shipment to support your quality assurance and regulatory compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, well-ventilated area at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive). Protect from excessive humidity and store away from incompatible materials to prevent caking and preserve stability.

Specification

Item	Specification
Description	White or almost white, crystalline powder
Identification (IR)	Conforms
Assay (HPLC)	98.0% - 102.0% (on dried basis)
Specific Rotation	+54.4° to +55.9°
pH (10% solution)	4.0 - 6.5
Loss on Drying	4.5% - 5.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 5 ppm
Microbial Limits	Meets Ph. Eur. / USP criteria

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.