Product Definition

Pharmaceutical grade lactose is produced by concentrating whey or permeate (a co-product of whey protein concentrate production) to over-saturate the lactose, then removing, refining, drying and milling the lactose crystals. Pharmaceutical grade lactose is produced to meet rigid specifications, such as specific form and size distribution, monohydrate, crystalline, 40 mesh to 325 mesh, and a spray-dried mixture of crystalline and amorphous lactose for all applications. All products meet the requirements of the U.S., European and Japanese Pharmacopeias.

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Typical Composition
Lactose (minimum)	99.8%
Protein	0.01%
Fat	0%
Ash	0.03%
Moisture	4.5-5.5%

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Physical and Chemical Characteristics

Typical Microbiological Analysis:
Standard plate count	<100/g
E. coli	Negative
Salmonella	Negative
Coagulase-positive staphylococci	Negative
Penicillin residues	Negative
Pesticide residues	Negative

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Other Characteristics:
Acidity or alkalinity	0.1 ml of 0.1N NaOH
Clarity and color (10% 1cm at 400nm)	0.01
Heavy metals	<5.0ppm
Loss on drying	0.3%

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Protein and Light Absorbing Impurities:
At 210-220 nm	0.06
At 210-300 nm	0.02
Residue on ignition	0.1%
Specific rotation	+54.5° to +55.9°
Bulk density, tapped	0.70-0.90g/ml (depends upon mesh size specifications)
Appearance	Pure white, crystalline, free-flowing powder
Solution	Clear, colorless, odorless
Flavor	Slightly sweet

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Storage

Typical recommendations are to store and ship in a cool, dry environment at temperatures less than 27ºC and relative humidity less than 65%. Check with your suppliers for actual storage and specification requirements as they vary.

Typical Applications

• As a diluent in tablets that have been manufactured by the wet granulation process
• As a filling agent in capsule formulations
• As a carrier for delivery of drug substances through inhalation