Description

α-D-Lactose Monohydrate is a high-purity, crystalline disaccharide sugar derived from milk. This versatile excipient is essential for its excellent binding, flow, and compressibility properties in solid dosage formulations. It is a critical raw material for the pharmaceutical, food, and biotechnology industries, serving as a key diluent, filler, and carrier agent. Its consistent quality ensures reliable performance in demanding manufacturing processes.

Application

• Pharmaceutical Excipient: Primarily used as a diluent, filler, and binder in the direct compression and wet granulation of tablets and capsules.
• Food & Beverage Ingredient: Employed as a nutritive sweetener, texturizer, and crystallization promoter in products like infant formula, confectionery, and baked goods.
• Microbiology & Biotechnology: Serves as a carbon source in fermentation media and microbial culture preparations.
• Animal Feed Supplement: Used as a digestible energy source and palatability enhancer in feed formulations.
• Diagnostic Reagents: Acts as a substrate or stabilizer in various clinical and biochemical diagnostic kits.
• Reference Standard: Utilized as an analytical standard in quality control laboratories for HPLC, TLC, and other methods.

Basic Information

Product Name	α-D-Lactose Monohydrate
CAS No.	5989-81-1
Molecular Formula	C12H22O11 • H2O
Molecular Weight	360.31 g/mol
Synonyms	Lactose Monohydrate; Milk Sugar; 4-O-β-D-Galactopyranosyl-D-glucose Monohydrate; α-Lactose Monohydrate; D-Lactose Monohydrate; Pharmatose; Tablettose; Fast-Flo Lactose; Anhydrous Lactose (when dehydrated); Saccharum Lactis
EINECS	202-559-2

Quality Control

Our α-D-Lactose Monohydrate is manufactured under strict quality management systems. It can be supplied to meet various pharmacopoeial standards, including USP-NF, Ph. Eur., JP, and FCC grades for food and pharmaceutical applications. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and safety parameters, ensuring full traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed after opening to prevent caking and degradation due to moisture absorption.

Specification

Item	Specification
Appearance	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°
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.