Description

Lactose, Monohydrate CAS NO 10039-26-6 is a naturally occurring disaccharide sugar derived from milk, widely recognized for its excellent excipient properties and nutritional value. It serves as a critical functional ingredient, providing essential bulk, stability, and controlled release characteristics in solid dosage formulations. This high-purity carbohydrate is indispensable for manufacturers in the pharmaceutical, food and beverage, and nutraceutical industries seeking reliable, compliant, and consistent raw materials for their production processes.

Application

• Pharmaceutical Excipient: Primarily used as a filler, diluent, and binder in the direct compression and wet granulation processes for tablet and capsule manufacturing.
• Dry Powder Inhalers (DPI): Serves as a carrier particle in inhalation formulations to ensure accurate and efficient drug delivery to the lungs.
• Food & Beverage Industry: Utilized as a sweetener, texturizer, and bulking agent in baked goods, confectionery, infant formula, and sports nutrition products.
• Microbiology & Fermentation: Acts as a carbon source in culture media for the growth of microorganisms in laboratory and industrial fermentation processes.
• Animal Feed: Incorporated as a palatability enhancer and energy source in specialized feed formulations.
• Cosmetics & Personal Care: Used in creams and lotions for its moisturizing (humectant) properties and as a mild abrasive in exfoliating products.

Basic Information

Product Name	Lactose, Monohydrate
CAS No.	10039-26-6
Molecular Formula	C12H22O11 · H2O
Molecular Weight	360.31 g/mol
Synonyms	Milk Sugar; Lactose Monohydrate; 4-O-β-D-Galactopyranosyl-D-glucose monohydrate; α-Lactose Monohydrate; β-Lactose Monohydrate; Saccharum Lactis; D-Lactose Monohydrate; Ph. Eur. Lactose Monohydrate
EINECS	200-559-2

Quality Control

Our Lactose Monohydrate is manufactured and tested under strict quality management systems to meet or exceed the requirements of major international pharmacopoeias, including USP-NF, Ph. Eur., and JP. Each batch undergoes rigorous analytical testing for identity, purity, assay, and physical properties to ensure batch-to-batch consistency and suitability for its intended application. A comprehensive Certificate of Analysis (COA) is provided with every shipment, and we can support compliance with cGMP, ISO, and other relevant regulatory standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, well-ventilated area at a 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 (Anhydrous Basis)	98.0% - 102.0%
Specific Optical Rotation	+54.4° to +55.9°
Water Content (Karl Fischer)	4.5% - 5.5%
pH (10% solution)	4.0 - 6.5
Heavy Metals	≤ 5 ppm
Residue on Ignition	≤ 0.1%
Microbial Limits	Conforms to Ph. Eur. 2.6.12 / USP <61>

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