+91 84258 80640 export@saliuspharma.com

Product Overview

Anhydrous lactose is a dehydrated form of lactose. It is a disaccharide sugar composed of glucose and galactose. It is commonly used as an inert filler in tablets and capsules to add bulk to formulations. It is also used in dry powder inhalers as a carrier for active pharmaceutical ingredients.

Product Type: Pharmaceutical Excipient

Chemical Name Anhydrous Lactose (β-D-Galactopyranosyl-(1→4)-D-glucose, anhydrous form)
Chemical Formula C₁₂H₂₂O₁₁
CAS Number 63-42-3
Molecular Weight 342.3 g/mol
Application Role Flow aid to improve powder handling, Binder in solid dosage forms
Regulatory Compliance IP / BP / USP / EP / NF
Manufacturing Suitability Suitable for direct compression due to good flow and compressibility; low moisture content ideal for moisture-sensitive APIs
Storage Conditions Store in a cool, dry place, protected from moisture and heat to prevent caking and degradation
Certifications cGMP, ISO
Availability Widely available globally from various pharmaceutical excipient suppliers
HS Code 170290

Excipient Technical Profile

Appearance White to off-white crystalline powder
Bulk Density Approximately 0.5 to 0.7 g/cm³
Solubility Moderately soluble in water; insoluble in ethanol and organic solvents
pH (1% aqueous solution) Approximately 5.0 to 7.0

Typical Applications

Key Benefits

Low moisture content
Chemical stability
Good flow properties
Wide compatibility
Excellent compressibility
Non-toxic and safe

Safety Info

⚠️Safety Information – Anhydrous Lactose

Toxicity

  • Non-toxic at levels used in pharmaceutical and food products
  • Oral LD₅₀ (rat): >10,000 mg/kg – indicates low acute toxicity

Allergenicity

  • May not be suitable for individuals with lactose intolerance or galactosemia
  • Not typically associated with allergic reactions unless related to milk protein contamination

Irritation

  • Non-irritant to skin, eyes, and respiratory tract under normal handling
  • Avoid inhalation of dust during industrial handling as it may cause mild mechanical irritation

Combustibility

  • Combustible as a fine dust and may pose an explosion risk in confined spaces
  • Avoid creating dust clouds near ignition sources

Storage Safety

  • Store in a cool, dry place in tightly sealed containers
  • Protect from moisture and contamination

Environmental Impact

  • Biodegradable and not considered hazardous to the environment in typical quantities

Regulatory Classification

  • GRAS (Generally Recognized As Safe) – per FDA
  • Listed in USP/NF, Ph. Eur., JP as pharmaceutical-grade excipient

Why Choose Salius Pharma?

  • GMP-Compliant Quality: Stringent QC to ensure consistent, premium-grade excipients.
  • Regulatory Support: Comprehensive documentation available.
  • Reliable Supply: Global distribution with 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

Anhydrous lactose contains no crystallization water, offering better stability with moisture-sensitive APIs and improved compressibility for direct compression.

Its consistent particle size and flow properties make it an ideal carrier for micronized APIs, improving dispersion and lung delivery.

Yes. Its slightly lower solubility compared to lactose monohydrate can influence dissolution and should be considered during formulation development.

Yes. COA, MSDS, DMF, Stability Data, COS, Impurity Profile, BA/BE Studies, and WHO-GMP/ISO certificates are available upon request.

It acts as a bulking agent and stabilizer, providing structural integrity and improved reconstitution properties.

You can contact export@saliuspharma.comor submit an inquiry through the website Visit On www.saliusapi.com Responses are provided within 24–48 hours.

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 Anhydrous Lactose 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.

Get in Touch

Confidentiality Notice

The contents of this page and any attachments are intended solely for the designated recipient(s) and may contain confidential and/or privileged information protected by law.

Any patented products are excluded from our offerings in regions where such patents are currently in force.

Send Enquiry
Chat With Us!
Call Us!
Mail Us!