LACTOSE, MONOHYDRATE
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LACTOSE, MONOHYDRATE
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CAS No:
10039-26-6
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Formula:
C12H22O11.H2O
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Chemical Name:
LACTOSE, MONOHYDRATE
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Synonyms:
AROSE 3:1 BIOTECHNOLOGY GRADE;AROSE 25;EC BROTH (ISO);D-(+)-Lactose 1-hydrate;LACTOSE 1H2O;MILK SUGAR MONOHYDRATE;MILK SUGAR;BETA-D-GAL-(1->4)-D-GLC MONOHYDRATE
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CAS No:
Description
White or almost white, crystalline powder.
In the solid state, lactose appears as various isomeric forms, depending on the crystallization and drying conditions, i.e. alactose monohydrate, b-lactose anhydrous, and a-lactose anhydrous. The stable crystalline forms of lactose are a-lactose monohydrate, b-lactose anhydrous, and stable a-lactose anhydrous.Lactose occurs as white to off-white crystalline particles or powder. Lactose is odorless and slightly sweet-tasting; a-lactose is approximately 20% as sweet as sucrose, while b-lactose is 40% as sweet.
Characteristics
198.76000
-5.46150
Solid
500kg/m3
~215 °C (dec.)
161g/L
4.0-6.5 (20°C, 100g/L in water)
390°C
room temp
Safety Information
3
Mold growth may occur under humid conditions (80% relative humidity and above). Lactose may develop a brown coloration on storage, the reaction being accelerated by warm, damp conditions. The purities of different lactoses can vary and color evaluation may be important, particularly if white tablets are being formulated. The color stabilities of various lactoses also differ. Solutions show mutarotation.Lactose should be stored in a well-closed container in a cool, dry place.
A Maillard-type condensation reaction is likely to occur between lactose and compounds with a primary amine group to form brown, or yellow-brown-colored products. The Maillard interaction has also been shown to occur between lactose and secondary amine. However, the reaction sequence stops with the formation of the imine, and no yellow-brown coloration develops.Lactose is also incompatible with amino acids, amfetamines, and lisinopril.
LACTOSE, MONOHYDRATE Use and Manufacturing
Excipient.
Lactose is a natural disaccharide consisting of galactose and glucose, and is present in the milk of most mammals. Commercially, lactose is produced from the whey of cows’ milk; whey being the residual liquid of the milk following cheese and casein production. Cows’ milk contains 4.4–5.2% lactose; lactose constitutes 38% of the total solid content of milk.a-Lactose monohydrate is prepared by crystallization from supersaturated solutions below 93.5°C. Various crystalline shapes are prism, pyramidal, and tomahawk; these are dependent on the method of precipitation and crystallization. Direct compression grades of a-lactose monohydrate are prepared by granulation/ agglomeration and spray-drying.
Registered Holders
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INDIA PHOSPHATE AND ALLIED INDUSTRIES PRIVATE LTD
Active
United States
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DFE PHARMA GMBH AND CO KG
Active
United States
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LACTOSE (INDIA) LTD
Active
United States
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