Lactose Monohydrate

Premium pharmaceutical grade filler and binder for direct compression and wet granulation applications.

Lactose Monohydrate

Product Overview

Lactose Monohydrate is one of the most widely used pharmaceutical excipients, serving as an excellent filler, binder, and carrier in tablet and capsule formulations. Its superior compressibility and flowability make it ideal for direct compression.

Key Features

  • Excellent compressibility
  • Good flowability
  • High purity
  • Low moisture content
  • Consistent particle size
  • Chemical stability
  • Regulatory compliant
  • Cost-effective

Technical Specifications

AppearanceWhite to off-white crystalline powder
Particle SizeD50: 60-90 μm
Moisture Content4.5 - 5.5%
Bulk Density0.60 - 0.70 g/cm³
Tapped Density0.80 - 0.90 g/cm³
Carr's Index≤ 25%

Assay (Anhydrous basis)98.0 - 102.0%
pH (10% solution)4.0 - 6.5
Heavy Metals≤ 5 ppm
Lead≤ 0.5 ppm
Chloride≤ 0.007%
Sulfate≤ 0.048%

Total Aerobic Count≤ 1000 CFU/g
Yeast & Mold≤ 100 CFU/g
E. coliAbsent/g
SalmonellaAbsent/10g
S. aureusAbsent/g

Applications

Direct Compression

Excellent filler and binder for direct compression tablets with superior compressibility.

Wet Granulation

Ideal for wet granulation processes, providing excellent binding properties.

Capsule Filling

Used as a diluent and carrier in hard gelatin capsule formulations.

Regulatory Compliance

IP
BP
USP
Ph.Eur

Certifications

ISO 9001
ISO 14001
ISO 45001
ISO 22000
WHO-GMP
HALAL

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