Description

Lactose Monohydrate is a high-purity, crystalline disaccharide sugar derived from milk. It serves as a critical and versatile excipient in pharmaceutical formulations, valued for its excellent compressibility, flow properties, and inert nature. This product is essential for manufacturers in the pharmaceutical, food, and biotechnology industries seeking a reliable and compliant ingredient for solid dosage forms, infant nutrition, and fermentation processes.

Application

• Pharmaceutical Excipient: Primarily used as a filler, diluent, and binder in the production of tablets and capsules.
• Direct Compression: An ideal carrier for active pharmaceutical ingredients (APIs) due to its excellent compressibility and flow characteristics.
• Dry Powder Inhalers (DPI): Acts as a carrier particle in inhalation formulations to ensure accurate and consistent drug delivery.
• Food & Nutritional Products: Used in infant formula, confectionery, and as a general sweetener or texturizer.
• Microbiological Culture Media: Serves as a carbon source in fermentation processes and for cultivating microorganisms.
• Animal Feed Supplement: Provides a source of energy in specialized feed formulations.

Basic Information

Product Name	Lactose Monohydrate
CAS No.	10039-36-6
Molecular Formula	C12H22O11 · H2O
Molecular Weight	360.31 g/mol
Synonyms	Milk Sugar; 4-O-β-D-Galactopyranosyl-D-glucose monohydrate; α-Lactose monohydrate; D-Lactose monohydrate; Saccharum lactis; Pharmatose; Respitose; GranuLac
EINECS	200-559-2

Quality Control

Our Lactose Monohydrate is manufactured under strict quality management systems. It is tested to meet relevant pharmacopoeial 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) detailing purity, identity, and safety parameters to ensure compliance with your specific application 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 product is hygroscopic (moisture-sensitive) and must be kept in original packaging until use to prevent caking and degradation.

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	4.5% - 5.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 5 ppm
Microbial Enumeration	Meets Ph. Eur./USP criteria

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