Lactose Pellets
Lactose Pellets
As critical pharmaceutical spherical adjuvant, Lactose pellets are used as neutral starter cores to be coated in the manufacture of controlled-release or sustained-release formulations,applied in capsules, tablets and sachets. Lactose is an important ingredient for the pharmaceutical industry. It is a white, naturally occurring non-hygroscopic sugar and is available in various milled, sieved and crystalline forms. Lactose Pellets is virtually inert and therefore compatible with a wide range of pharmaceutically active substances making it the ideal excipient in many applications. Each application requires its own specific functionality of lactose.
◆Characteristics:
Appearance: White or kind of white near circular pellets.
Density: Can be adjusted as per the product’s characteristics
Standard: Conform to USP/NF
◆Chemical specifications
Loss on drying 4.00 %
Sulphated ash 0.20 %
Heavy metals 5 ppm
Starch content < 92 %
◆Physical properties
True density * 1.550 – 1.590 g/cm3 (vary with the particle size)
Surface area (BET) * > 0.100 m²/g
Carr index < 10 %
Flow time < 10 s for 100 g
◆Microbiological specifications
Total aerobic bacteria count ≤100/g
Salmonella Absent/1g
Escherichia coli Absent/1g
Moulds ≤100/g
◆ Size Specifications
Product ID |
Granule-diameter (µm) |
P1 |
300-500 |
P2 |
500-710 |
P3 |
600-800 |
P4 |
700-900 |
P5 |
900-1120 |
◆General information
Packaging: 25 kg cardboard drums, tightly closed, with two polyethylene liners.
Storage conditions: in original sealed drums, protected from humidity, at a temperature between 15°C to 30°C.
Shelf life: 3 years guaranteed.
Samples kept for 5 years and records available for 6 years.
Certificate of analysis and Material Safety Data Sheet attached to each delivery.