Description

Lactose is a naturally occurring disaccharide sugar derived from milk, widely recognized for its versatility as an excipient and nutritive sweetener. Its excellent compressibility, low hygroscopicity relative to other sugars, and inert nature make it a cornerstone ingredient in numerous industrial formulations. This product is essential for manufacturers in the pharmaceutical, food and beverage, and biotechnology sectors seeking a reliable and multifunctional raw material.

Application

• Pharmaceutical Excipient: Primarily used as a filler, binder, and diluent in tablet and capsule formulations for both direct compression and wet granulation processes.
• Food & Beverage Industry: Employed as a sweetener, texturizer, and bulking agent in baked goods, confectionery, infant formula, and seasoning blends.
• Microbiology & Fermentation: Serves as a key carbon source in microbial culture media for the production of antibiotics, enzymes, and other fermented products.
• Animal Feed: Used as a nutritive additive and palatability enhancer in feed premixes for livestock.
• Carrier for Dry Powder Inhalers (DPI): Acts as an inert carrier particle for active pharmaceutical ingredients in respiratory drug delivery systems.
• Starter Cultures: Provides a fermentable sugar to support the growth of lactic acid bacteria in dairy product manufacturing.

Basic Information

Product Name	Lactose
CAS No.	63-42-3
Molecular Formula	C12H22O11
Molecular Weight	342.30 g/mol
Synonyms	Milk sugar; 4-O-β-D-Galactopyranosyl-D-glucose; Saccharum lactis; D-Lactose; (+)-Lactose; Anhydrous lactose; Lactose monohydrate; β-Lactose
EINECS	200-559-2

Quality Control

Our Lactose is produced and tested under a strict quality management system to ensure batch-to-batch consistency and compliance with major pharmacopoeial standards. We offer grades that conform to USP-NF, Ph. Eur., and FCC specifications, ensuring suitability for pharmaceutical, food, and industrial applications. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and physical parameters, is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after initial opening to minimize moisture absorption.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Assay (Anhydrous basis)	98.0% - 102.0%
Specific Optical Rotation	+54.4° to +55.9°
pH (10% solution)	4.0 - 7.0
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 5 ppm
Microbial Limits	Meets Ph. Eur. 2.6.12 / USP <61> requirements

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