Description

D-Lactose Monohydrate is a high-purity, crystalline sugar derived from milk, serving as a critical excipient and raw material in advanced manufacturing. Its consistent quality and reliable performance make it indispensable for ensuring product stability and efficacy in sensitive formulations. This product is essential for manufacturers in the pharmaceutical, food, and biotechnology industries seeking a dependable and compliant ingredient.

Application

• Pharmaceutical Excipient: Widely used as a diluent, filler, and binder in the production of tablets and capsules, including direct compression formulations.
• Food & Beverage Additive: Employed as a sweetener, texturizer, and carrier for flavors and colors in dairy products, confectionery, and baked goods.
• Microbiology & Fermentation: Serves as a defined carbon source in microbial culture media and fermentation processes for antibiotic and enzyme production.
• Infant Formula: A key carbohydrate component in the manufacturing of nutritional products and infant milk formula.
• Animal Feed Supplement: Used as a palatability enhancer and energy source in premium pet food and livestock feed.
• Diagnostic Reagents: Acts as a stabilizer and bulking agent in the formulation of various clinical and diagnostic test kits.

Basic Information

Product Name	D-Lactose Monohydrate
CAS No.	14641-93-1
Molecular Formula	C₁₂H₂₂O₁₁·H₂O
Molecular Weight	360.31 g/mol
Synonyms	D-(+)-Lactose Monohydrate; 4-O-β-D-Galactopyranosyl-D-glucose Monohydrate; Milk Sugar; Lactose; Saccharum Lactis; Lactobiose; Anhydrous Lactose (when dehydrated); Fast-Flo Lactose
EINECS	200-559-2

Quality Control

Our D-Lactose Monohydrate is manufactured under strict quality management systems. It is tested to meet relevant pharmacopeial standards such as USP-NF, Ph. Eur., and JP, as well as food-grade specifications like FCC. Every batch is accompanied by a comprehensive Certificate of Analysis (COA) to ensure traceability, purity, and compliance with your specific requirements.

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 material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed 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.