+91 84258 80640 export@saliuspharma.com

Product Overview

Lactose Monohydrate is a white, odorless powder made from milk and is widely used in the pharmaceutical and food industries. In medicines, it acts as a filler or binder, helping to shape tablets and capsules and ensure even distribution of the active ingredients. It flows well, compresses easily, and is stable under normal storage conditions, making it ideal for large-scale production. Because it’s safe, reliable, and easy to work with, it's a preferred ingredient in many oral solid dosage forms like tablets, powders, and chewables.

Product Type: Pharmaceutical Excipient

Chemical Name Lactose Monohydrate (also known as Milk Sugar Monohydrate)
Chemical Formula C₁₂H₂₂O₁₁·H₂O
CAS Number 64044-51-5
Molecular Weight 360.31 g/mol
Application Role Commonly used as a filler, binder, and stabilizer in pharmaceutical tablets, capsules, dry powder inhalers, and food products.
Regulatory Compliance USP / NF / EU / JP
Manufacturing Suitability Ideal for direct compression and wet granulation in solid oral dosage forms; also suitable for food and nutraceutical applications.
Storage Conditions Store in a tightly closed container in a cool, well-ventilated area, away from heat, sparks, or open flame
Certifications GMP, ISO 9001:2008 / 2015, FSSC 22000 (if food-grade)
Availability On-demand production / Global supply capability
HS Code 1702.11.00 – Lactose and lactose syrup, containing by weight 99% or more lactose

Excipient Technical Profile

Appearance White to off-white crystalline powder.
Bulk Density ≈ 1.20–1.21 g/mL
Solubility Freely soluble in water (~18.9 g/100 mL at 25°C); practically insoluble in alcohol and most organic solvents
Melting Point ~4.5 – 7.0

Typical Applications

Key Benefits

Biocompatible and biodegradable
Naturally derived
Effective pH regulator
Regulatory approved

Safety Info

Lactose Monohydrate is an organic acid commonly used in pharmaceutical, cosmetic, food, and industrial applications. While generally recognized as safe (GRAS) for approved uses, concentrated solutions can be corrosive and require proper handling.

⚠️ Key Safety Considerations

  • Corrosive in concentrated form – may cause skin and eye irritation
  • Use protective gloves and eyewear when handling industrial-grade material
  • Avoid inhalation of mists or vapors – ensure adequate ventilation
  • Store in tightly closed containers in a cool, dry, well-ventilated area
  • Incompatible with strong oxidizers and bases – risk of hazardous reactions

Why Choose Salius Pharma?

  • GMP-Compliant Quality: Adherence to GMP with Stringent QC to ensure consistent, premium-grade excipients.
  • Regulatory Support: Comprehensive documentation available.
  • Reliable Supply: Global distribution with safe and timely delivery.
  • Technical Expertise: Dedicated formulation support and customer service.
  • Customized Solutions: Flexible packaging and product grades tailored to your needs.
Documents We Provide

FAQs

Lactose Monohydrate is a highly stable and compressible excipient used as a filler or binder in tablets, capsules, and powders. Its compatibility with APIs and good flow properties makes it a top choice in solid dosage manufacturing.

Salius offers pharma- and food-grade Lactose Monohydrate in various particle sizes suitable for direct compression, wet granulation, and inhalation formulations. Grades comply with USP, Ph.Eur., JP, and FCC standards.

Our team provides full support for regulatory documentation, including CoAs, GMP, ISO certifications, TSE/BSE declarations, and DMF availability where required. We assist with dossier submissions and country-specific compliance.

Lactose Monohydrate is packed in 25 kg fiber drums, HDPE drums, or paper bags with PE liners. All packaging is moisture-resistant and designed to maintain product integrity during international transit.

Yes. We support bulk shipments and urgent dispatches with global logistics partnerships. Depending on stock and destination, we offer air or sea freight with tracking and documentation ready for customs clearance.

Visit www.saliusapi.com and fill out the Request a Quote form.
Or email us directly at export@saliuspharma.com with details such as product grade, quantity, packaging type, and destination port.

What You Receive with Every Order

At Salius Pharma, we deliver more than just an excipient — we deliver confidence, compliance, and quality. Every shipment is thoughtfully prepared to meet international regulatory standards and your exact specifications.

What’s Included:

✔ Premium Product:
✔ Custom Packaging Options:

Place an Order or Request a Quote from Salius Pharma

Looking to source Lactose Monohydrate or other high-quality pharmaceutical products?
We’re here to help.
Whether you need Active Pharmaceutical Ingredients (APIs), excipients, or regulatory support, our team is ready to provide reliable, compliant, and cost-effective solutions tailored to your market needs.

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