Lactose Monohydrate
Lactose Monohydrate is a widely used pharmaceutical and food-grade excipient with excellent compressibility, flowability, and stability. It is especially suitable for direct compression tablets, capsules, infant nutrition, and dairy-based formulations.
Available grades
- Packaging
- 25 kg/bag
- Minimum order
- 1 kg
- Payment type
- L/C,T/T,D/P
- Port
- Qingdao,Shanghai
Product inquiry
Lactose Monohydrate
Overview
Product details
Lactose is a naturally occurring carbohydrate extracted from whey, widely found in dairy products. In the human body, it is hydrolyzed by lactase into glucose and galactose, which are absorbed into the bloodstream to provide energy.
Lactose Monohydrate contains one molecule of crystallization water, giving it a stable crystal structure and excellent processing characteristics. With fine particle size and high surface area, it offers outstanding flowability, compressibility, and blending performance.
These properties make it an ideal excipient for direct compression in tablet manufacturing and capsule filling, while also being widely used in infant nutrition, dairy products, freeze-dried foods, and solid beverage formulations.
Its mild sweetness, good solubility, and consistent quality make lactose monohydrate a reliable and cost-effective ingredient for both pharmaceutical and food applications.
Technical data
Key specifications
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Odor | Odorless |
| Particle Size | 40 mesh / 100 mesh / 200 mesh / customizable |
| Moisture | 4.5-5.5% |
| Loss on Drying | ≤1.0% |
| Residue on ignition | ≤0.1% |
| Heavy Metals | ≤ 5 ppm |
| Microbial Limits | Compliant with pharmacopoeia / food standards |
| Shelf life | 24 months |
| Storage Conditions | Store in a cool, dry and well-ventilated place. Keep the package tightly sealed and protect from moisture, heat and direct sunlight. |
Applications
Pharmaceutical Applications
- Tablet fillers and diluents
- Capsule formulations
- Direct compression excipient
Food & Nutrition Applications
- Infant formula
- Dairy products
- Solid beverages
- Freeze-dried products
Functional Performance
- Promotes fast disintegration in tablets
- Improves taste and mouthfeel in chewable tablets
Core advantages
Excellent Compressibility
Provides strong binding properties, making it highly suitable for direct compression tablet formulations.
Superior Flowability & Blend Uniformity
Fine and uniform particle size ensures smooth processing and consistent mixing with active ingredients.
Cost-Effective Excipient Solution
Offers a balance between performance and cost, making it the most widely used filler in pharmaceutical and food industries.
Mild Sweetness & Good Taste
Approximately 15% sweetness of sucrose, improving palatability for chewable tablets and nutritional products.
Stable and Easy to Store
Low moisture content and low hygroscopicity reduce caking and extend shelf life.
Wide Application Compatibility
Suitable for tablets, capsules, infant formula, dairy products, and solid beverages.
Quality assurance
Certifications & documents
Compliance standards
Certifications
Available documents
- Specification
- COA
- TDS
- MSDS
Questions
Frequently asked questions
Can you provide samples before placing a bulk order?
Yes. We provide samples for laboratory assessment and trial production so your team can validate quality and performance before committing to a full order.
What documentation do you supply with each shipment?
We provide complete documentation including COA, specifications, TDS, MSDS and compliance certificates aligned with FDA, ISO, FSSC 22000 and other required standards.
Do you support custom grades and specifications?
We confirm application, grade, particle size and quality standards during requirement analysis, and our in-house R&D laboratory supports formulation and specification adjustments.
What are your typical lead times and minimum order quantities?
Lead time and MOQ depend on the product and packaging. Please send us your target quantity and we will confirm an accurate schedule and quotation.
Which countries do you export to?
Our products are exported to more than 30 countries, with export documentation, shipping and order tracking handled by our team.
Ready to source?
Request pricing and documentation for Lactose Monohydrate.
Share your application, target specification or current COA and our technical team will recommend the right grade and documentation package.