| Identification | More | [Name]
Lactose | [CAS]
63-42-3 | [Synonyms]
4-(B-D-GALACTOSIDO)-D-GLUCOSE
4-O-BETA-GALACTOPYRANOSYL-D-GLUCOSE
BETA-LACTOSE
D-(+)-LACTOSE
D-LACTOSE
LACTIN
LACTOBIOSE
LACTOSE
MILK SUGAR
SUGAR MILK
4-o-beta-d-galactopyranosyl-d-glucos
Aletobiose
Galactinum
lactose,anhydrous
Osmolactan
Saccharum lactin
saccharumlactin
LACTOSE ANHYDROUS, PH EUR
D-(+)-LACTOSE (ANHYDROUS) EP STANDARD
LactoseHydrate | [EINECS(EC#)]
200-559-2 | [Molecular Formula]
C12H22O11 | [MDL Number]
MFCD00151251 | [Molecular Weight]
342.3 | [MOL File]
63-42-3.mol |
| Chemical Properties | Back Directory | [Appearance]
white crystals or powder | [Melting point ]
222.8°C | [Boiling point ]
397.76°C (rough estimate) | [density ]
1.5300 | [refractive index ]
1.5376 (estimate) | [storage temp. ]
2-8°C | [solubility ]
Freely but slowly soluble in water, practically insoluble in ethanol (96 per cent). | [form ]
Powder | [pka]
12.39±0.20(Predicted) | [color ]
White to Off-white | [Odor]
wh. hard cryst. mass or wh. powd., odorless to sl. char. odor but readily absorbs odors, mildly swee | [Stability:]
Stable. Incompatible with strong oxidizing agents. | [Water Solubility ]
5-10 g/100 mL at 20 ºC | [BRN ]
93796 | [LogP]
-3.391 (est) | [Uses]
Lactose is a disaccharide carbohydrate that occurs in mammalian
milk except that of the whale and the hippopotamus. it is princi-
pally obtained as a cows’ milk derivative. it is also termed milk sugar
and it is a reducing sugar consisting of glucose and galactose. its
most common commercial form is alpha-monohydrate, with the
beta-anhydride form available to a lesser extent. all forms in solution
will equilibrate to a beta:alpha ratio of 62.25:37.75 at 0°c. it is about
one-sixth as sweet as sugar and is less soluble. it functions as a flow
agent, humectant, crystallization control agent, and sweetener. it is
used in baked goods for flavor, browning, and tenderizing and in
dry mixes as an anticaking agent. | [CAS DataBase Reference]
63-42-3(CAS DataBase Reference) | [NIST Chemistry Reference]
D-Glucose, 4-o-«beta»-D-galactopyranosyl-(63-42-3) | [EPA Substance Registry System]
63-42-3(EPA Substance) |
| Hazard Information | Back Directory | [General Description]
White hard crystalline powder. | [Reactivity Profile]
Flammable and/or toxic gases are generated by the combination of alcohols with alkali metals, nitrides, and strong reducing agents. They react with oxoacids and carboxylic acids to form esters plus water. Oxidizing agents convert them to aldehydes or ketones. Alcohols exhibit both weak acid and weak base behavior. They may initiate the polymerization of isocyanates and epoxides. | [Air & Water Reactions]
Water soluble. | [Health Hazard]
ACUTE/CHRONIC HAZARDS: This chemical should be considered toxic. | [Chemical Properties]
Anhydrous lactose occurs as white to off-white crystalline particles
or powder. Several different brands of anhydrous lactose are
commercially available which contain anhydrous b-lactose and
anhydrous a-lactose. Anhydrous lactose typically contains 70–80%
anhydrous b-lactose and 20–30% anhydrous a-lactose. | [Chemical Properties]
white crystals or powder | [Definition]
A sugar found in milk. It is a disaccharide
composed of glucose and galactose units. | [Production Methods]
There are two anhydrous forms of lactose: a-lactose and b-lactose.
The temperature of crystallization influences the ratio of a- and blactose.
The anhydrous forms that are commercially available may
exhibit hygroscopicity at high relative humidities. Anhydrous
lactose is produced by roller drying a solution of lactose above
93.5°C. The resulting product is then milled and sieved. Two
anhydrous a-lactoses can be prepared using special drying
techniques: one is unstable and hygroscopic; the other exhibits
good compaction properties. However, these materials are not
commercially available. | [Pharmaceutical Applications]
Anhydrous lactose is widely used in direct compression tableting
applications, and as a tablet and capsule filler and binder.
Anhydrous lactose can be used with moisture-sensitive drugs due
to its low moisture content. It may also be used in intravenous
injections. | [Safety]
Lactose is widely used in pharmaceutical formulations as a diluent
and filler-binder in oral capsule and tablet formulations. It may also
be used in intravenous injections. Adverse reactions to lactose are
largely due to lactose intolerance, which occurs in individuals with a
deficiency of the intestinal enzyme lactase, and is associated with
oral ingestion of amounts well over those found in solid dosage
forms. | [storage]
Mold growth may occur under humid conditions (80% RH and
above). Lactose may develop a brown coloration on storage, the
reaction being accelerated by warm, damp conditions. At 80°C and 80% RH, tablets containing anhydrous lactose
have been shown to expand 1.2 times after one day.
Lactose anhydrous should be stored in a well-closed container in
a cool, dry place. | [Purification Methods]
-Lactose crystallises from water below 93.5o as the hydrate which can be dried at 80o/14mm. [Horst Recl Trav Chim, Pays-Bas 72 878 1953, Beilst 17 III/IV 3066.] | [Incompatibilities]
Lactose anhydrous is incompatible with strong oxidizers. When
mixtures containing a hydrophobic leukotriene antagonist and
anhydrous lactose or lactose monohydrate were stored for six
weeks at 40°C and 75% RH, the mixture containing anhydrous
lactose showed greater moisture uptake and drug degradation.
Studies have also shown that in blends of roxifiban acetate
(DMP-754) and lactose anhydrous, the presence of lactose
anhydrous accelerated the hydrolysis of the ester and amidine
groups.
Lactose anhydrous is a reducing sugar with the potential to
interact with primary and secondary amines (Maillard reaction)
when stored under conditions of high humidity for extended
periods. | [Regulatory Status]
GRAS listed. Included in the FDA Inactive Ingredients Database
(IM, IV: powder for injection solution; IV and sublingual preparations;
oral: capsules and tablets; powder for inhalation; vaginal).
Included in nonparenteral and parenteral medicines licensed in the
UK. Included in the Canadian List of Acceptable Non-medicinal
Ingredients. |
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