Hangzhou Chengyuan Biotech Co., Ltd.

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 %

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◆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.