Lactose Crystalline Monohydrate Family by Kerry
Excipients for direct tabletting, granulation, capsules, sachet filling and inhalation
Lactose is a disaccharide of glucose and galactose obtained from the whey fraction of bovine milk. Depending on the temperatures used to crystallize and dry the lactose solution, it may be produced in either of two crystalline types: monohydrate or anhydrous.
In addition, the lactose disaccharide also has the ability to form two stable isomers known as alpha-lactose and beta-lactose. These two isomers differ in the orientation of the hydroxyl group in the glucose moiety. The monohydrate crystal in primarily the alpha-form, whereas the anhydrous crystal is primarily the beta-form (Zadow, 1984). At equilibrium in water at room temperature, both forms will be present as 62.3% beta-form and 37.7% alpha-form (Whittier, 1944).
• Inert material, high purity, low color
• Moisture stable – 4 year shelf life
• Physically and chemically stable
• Several off-the-shelf grades and custom capabilities
• Milling & Sieving Capabilities (high flow grades available)
• Control of raw material – no supply issues
• High degree of crystallinity, low amorphous content
Products & Recommended Applications
General Physical and Chemical Characteristics
Monohydrate Lactose is a disaccharide obtained from the whey fraction of milk, and consists of one glucose and one galactose moiety. Sheffield™ Monohydrate Lactose is crystalline alpha-monohydrate anomers. Sheffield™ brand meet all requirements of the National Formulary as well as the European and Japanese Pharmacopeias.
Other Physical Characteristics
Free-flowing, non-hygroscopic powder. White to creamy white in color, free of sediment and with excellent stability. A 10% solution (in boiling water) is clear to nearly colorless. Soluble in water at 25°C (77°F) is 20g/100ml.
Packaging and Storage
Store in cool, dry area with container closed when not in use. A minimum shelf life of 48 months is expected for unopened packages.
The standard packaging is a polyethylene lined fiber drum with tamper evident seals. The standard net weight for Sheffield™ Monohydrate Lactose is 95kg, but Monohydrate Impalpable is 90kg. This product is also available in 100 lb drums or 25kg paper sacks upon request.
Particle Size Curves
See the full brochure on “Lactose Crystalline Monohydrate Family by Kerry“ here
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Source: Kerry brochure “Lactose Crystalline Monohydrate Family by Kerry”
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