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LACTOSE MONOHYDRATE


EC / List no.: 611-913-4
CAS no.: 5989-81-1 / 64044-51-5 / 10039-26-6

Lactose monohydrate is the crystalline form of lactose, the main carb in cow’s milk.

Lactose is composed of the simple sugars galactose and glucose bonded together. 
Lactose monohydrate exists in two forms that have different chemical structures — alpha- and beta-lactose.

Lactose monohydrate is produced by exposing alpha-lactose from cow’s milk to low temperatures until crystals form, then drying off any excess moisture.

The resulting product is a dry, white or pale yellow powder that has a slightly sweet taste and smells similar to milk.

Lactose monohydrate occurs as white to off-white crystalline particles or powder. 
Lactose monohydrate is odorless and slightly sweet-tasting. 
Spray-dried directcompression grades of lactose are generally composed of 80–90% specially prepared pure a-lactose monohydrate along with 10–20% of amorphous lactose.

alpha-D-Lactose monohydrate is used as a carrier and stabiliser of aromas, pharmaceutical products, Food industry.

Production Methods
A suspension of a-lactose monohydrate crystals in a lactose solution is atomized and dried in a spray drier. 
Approximately 10–20% of the total amount of lactose is in solution and the remaining 80–90% is present in the crystalline form. 
The spray-drying process predominantly produces spherical particles. 
The compactibility of the material and its flow characteristics are a function of the primary particle size of the lactose monohydrate and the amount of amorphous lactose.

A sugar that occurs in many plants. 
Lactose monohydrate is extracted commercially from sugar cane and sugar beet. 
Sucrose is a disaccharide formed from a glucose unit and a fructose unit. 
Lactose monohydrate is hydrolyzed to a mixture of fructose and glucose by the enzyme invertase. 
Since this mixture has a different optical rotation (levorotatory) than the original sucrose, the mixture is called invert sugar.


Biochem/physiol Actions
Lactose monohydrate is the primary sugar present in milk and the main energy source to a newborn mammalian through its mother′s milk. 
Lactose monohydrate is digested by the intestinal lactase (EC 3.2.1.108), an enzyme expressed in newborns. 
The enzyme′s activity declines following weaning which can lead to lactose intolerance in adult mammals.


Properties    
white or almost white crystalline granules or powder, odorless, slightly sweet. 
The sweetness of α-lactose is 15% of sucrose. The β-lactose has a higher sweetness than α-lactose. Lactose monohydrate is soluble in water, insoluble in alcohol, insoluble in ether and chloroform. 
The lactose monohydrate has a water content of 4.5% -5.5%, while the anhydrous hydrate has a water content of less than 1%. 9.75% (w / v) aqueous solution is isotonic with serum.

Stability and storage conditions    
Lactose monohydrate is easily contaminated by mold in moist conditions (humidity greater than 80%). 
The color of lactose may turn brown as storage time is extended with moist and heat accelerating this change. 
Lactose monohydrate is stable in air and is unaffected by moisture at room temperature, but amorphous form of lactose is dependent on the degree of dryness and may be subject to moisture to be converted to monohydrate. 
Monohydrate, when heated to 120 ℃, can be converted into anhydrous. 
A saturated solution of beta-lactose may be precipitated into α-lactose crystals during placement, and the solution has a twisted optical rotation property. 
Lactose should be placed in airtight container and stored in a cool dry place.

Compatibility & incompatibility    
Lactose can reacted with primary amine compounds to produce a brown product; the amorphous lactose is more likely participated into this reaction than crystalline lactose. 
Lactose has incompatibility with amino acids, aminophylline, amphetamine and isoniazid. 
Prescription containing tartrate, citrate or acetate, etc., or alkaline lubricants can accelerate the discoloration reaction.

Production process    
Use the product of producing cheese or casein - whey as raw material, remove the protein content, followed by concentration, cooling, lactose crystallization and some other processes to obtain the dairy products. 
Mainly used in food industry, medicine and chemical reagents. 
Production process: raw whey material- → protein separation - →whey concentration - → cooling and crystallization of lactose - → molasses separation - → lactose washing - → drying (crude lactose) → refining treatment (refined lactose). 
Raw whey contains whey protein and a small amount of casein, which can be separated through adding line milk to the whey to pH 6.2 ~ 6.5 and simultaneously heating to over 90 ℃ for protein precipitation. 
Next, the cleared whey is then vacuumed concentrated to 35Be '(70% dry matter, Be' denotes Baume, a specific gravity unit) and cooled to 18-20 ° C for 24 hours to crystallize the lactose. 
In order to speed up the crystallization process and increase the yield, an appropriate amount of crystallization inducer (lactose powder or crystallized liquid lactose) can be added at the initial stage of crystallization. 
Crystal should be separated out of molasses using centrifugal dewatering machine and washed with water and finally dried to obtain crude lactose. 
In the dairy industry, refined lactose is usually produced, but since the crude lactose is yellow and contains more impurities, it needs to be refined before obtaining refined lactose. 
First, dissolve the crude lactose in warm water; add the decolorant (bone charcoal or activated charcoal) to decolorize; or use ion exchange resin for salt treatment; or use milk protein and calcium chloride for further removing the proteins. 
Then again apply concentration, drying to make refined lactose. 
The protein precipitate separated during the production of lactose can be used as a feed, and the separated molasses can also be used as a raw material for feed or lactic acid fermentation.

General Description    
In nature, it only exists in mammalian milk. 
Lactose monohydrate belongs to disaccharides, being composed of one molecule of glucose and one molecule of galactose with a sweetness of about 16. 
Milk contains about 4.3% ~ 4.5% of lactose. 
There are two isomers of lactose, namely, α-and β-type, being monohydrate and anhydrous, respectively. 
The α-lactose usually contains one molecule of crystal water with the melting point of 202 °C; β-type is as an anhydride with the melting point of 252 °C and has a higher sweetness and higher solubility than α-type. 
Lactose is made from whey, a by-product of cheese or casein, and is used in large quantities as a drug excipient, as a nutrient for infants and young children, and as a good medium for penicillin.
Lactose monohydrate is used as a diluent for soluble powder dispersions, oral capsules, powder inhalers and tablets; lactose is also used in lyophilisates and intravenous injections.

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.


Biochem/physiol Actions    
Lactose monohydrate is a dissacharide formed by the condensation of one galactose and one glucose molecule. 
Lactose monohydrate is the major sugar in the milk of most species, typically present between 2-8%. 
The enzyme lactase hydrolyzes lactose to its constituent monosaccharides. 
In neonates, glucose released via the action of lactase is a major energy sour


Uses of lactose monohydrate
Lactose monohydrate is known as milk sugar in the food and pharmaceutical industries.

Lactose monohydrate has a long shelf life, slightly sweet taste, and it’s highly affordable and widely available. 
What’s more, it easily mixes with numerous ingredients.

As such, it’s commonly used as a food additive and filler for drug capsules. 
It’s primarily used for industrial purposes and not typically sold for home use. 
Thus, you may see it on ingredient lists but won’t find recipes that call for it.

Fillers like lactose monohydrate bind to the active drug in a medication so that it can be formed into a pill or tablet that can be easily swallowed.

In fact, lactose in some form is used in over 20% of prescription medications and over 65% of over-the-counter drugs, such as certain birth control pills, calcium supplements, and acid reflux medications.

Lactose monohydrate is also added to infant formulas, packaged snacks, frozen meals, and processed cookies, cakes, pastries, soups, and sauces, as well as several other foods.

Its primary purpose is to add sweetness or act as a stabilizer to help ingredients that don’t mix — such as oil and water — stay together.

Finally, animal feed often contains lactose monohydrate because it’s a cheap way to increase food bulk and weight.

Lactose monohydrate is a crystallized form of milk sugar.

It’s commonly used as a filler for medications and added to packaged foods, baked goods, and infant formulas as a sweetener or stabilizer.

This additive is widely considered safe and may not cause symptoms in those who are otherwise lactose intolerant.


Lactose is the principal sugar in human and most other mammalian milks, ( 4-O-(β-d-galactopyranosyl)-d-glucopyranose).
 Lactose undergoes mutarotation; it is a reducing sugar and is significantly less soluble in water than sucrose. 
Lactose is much less sweet than sucrose (at ~1% about 0.15 (sucrose=1). 
The enzyme lactase (β-galactosidase), which is present in the small intestine, catalyzes hydrolysis of lactose to form glucose and galactose. 
Anhydrous lactose is an excipient, filler, diluent, and bulking agent in a wide variety of pharmaceutical tablets, capsules, powders and other preparations. 
Lactose also has applications as a nutrient and multi-functional ingredient in infant formulae, geriatric, dietetic and health foods.


Lactose is the most important carbohydrate in the milk of most species. 
Its biosynthesis takes place in the mammary gland. 
The molecular structures of α- and β -lactose differ in the orientation of a hydrogen- and a hydroxyl group on carbon atom no.1 in the glucose moiety. 
Both forms change into one another continuously. 
At room temperature, the equilibrium results in a ratio of about 40% α-lactose and 60% β-lactose.
The fact that two forms of lactose exist which differ in molecular structure has profound effects on various properties of lactose such as crystallization behavior, crystal morphology, solid-state properties, and solubility. 
The intestine does not actively absorb lactose unless it is split into its two-monosaccharide components, i.e. glucose and galactose. 
This hydrolysis of lactose is affected by the enzyme lactase, which is produced by the epithelium cells in the brush-border of the small intestine. 
Thus, the capacity of mammals to digest lactose is dependent on the lactase activity in the intestine. 
The maximum activity of the enzyme occurs shortly after birth and declines during the weaning period, after which it remains at a relatively constant level. 
Genetically determined factors governing residual lactase activity also exist. 
Individuals having low lactase activity are called lactose malabsorbers. 
Lactose intolerance is a condition in which people have symptoms due to the decreased ability to digest lactose. 
The principal symptom of lactose intolerance is an adverse reaction to products containing lactose (primarily milk), including abdominal bloating and cramps, flatulence, diarrhea, nausea, borborygmi, and vomiting (particularly in adolescents). 
These appear one-half to two hours after consumption.


Lactose monohydrate is a naturally occurring simple carbohydrate, or sugar, found only in the milk of mammals. 
For this reason, it is also commonly referred to as “milk sugar.” 
All commercial lactose is obtained from the milk of cows as a by-product of the dairy industry. 
Chemically, lactose is the disaccharide of the simple sugars D-galactose and D-glucose. 
In other words, the lactose molecule comprises one molecule of D-galactose chemically linked to one molecule of D-glucose. 
Lactose monohydrate exists in two isomeric forms, known as alpha and beta (designated a-lactose and b-lactose


Formula: C12H22O11•H2O
Formula Weight: 360.32 (342.30anhy)
Melting point: 207-211° dec.
Density: 1.525
Storage & Sensitivity: Ambient temperatures.
Solubility: Soluble in water.

Uses:
Lactose monohydrate is used as a carrier and stabiliser of aromas, pharmaceutical products, Food industry.

IUPAC NAMES:
alpha-D-Glucopyranose, 4-O-beta-D-galactopyranosyl-, monohydrate


SYNONYMS:
Lactose monohydrate
5989-81-1
alpha-Lactose monohydrate
alpha-D-Lactose monohydrate
64044-51-5
D-Lactose monohydrate
a-Lactose monohydrate
UNII-EWQ57Q8I5X
alpha-lactose hydrate
Lactose, monohydrate
Lactose monohydrate [NF]
EWQ57Q8I5X
Respitose
a-D-Glucopyranose, 4-O-b-D-galactopyranosyl-, monohydrate
(2R,3R,4S,5,6S)-2-(hydroxymethyl)-6-[(2R,3S,4R,5R,6S)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol;hydrate
Lactose monohydrate (NF)
ALPHA-LACTOSEMONOHYDRATE
Lactose Monohydrate (Alpha-Form)
Microtose
Pharmaose
10039-26-6
(2S,3R,4R,5S,6R)-6-(Hydroxymethyl)-5-(((2S,3,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydro-2H-pyran-2,3,4-triol hydrate
Spherolac 100
Alpha-lactose,monohydrate
alpha-D-Glucopyranose, 4-O-beta-D-galactopyranosyl-, monohydrate
Lactose (TN)
Lactose(Monohydrate)
Lactose (JP17)
(2R,3,4S,5R,6S)-2-(hydroxymethyl)-6-[(2R,3S,4R,5R,6S)-4,5,6-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxytetrahydropyran-3,4,5-triol
SCHEMBL16787
D-Glucose, 4-O-beta-D-galactopyranosyl-, monohydrate
DTXSID1052828
CHEBI:189432
alpha-Lactose, analytical standard
AKOS015896871
FS-3862
NSC 760401
MALONICACIDDISODIUMSALTMONOHYDRATE
(2R,3R,4S,,6S)-2-(hydroxymethyl)-6-[(2R,3S,4R,5R,6S)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol hydrate
CS-0128727
D03226
alpha-4-O-(beta-D-galactopyranosido)-D-glucopyranose
Q27277391
alpha-Lactose monohydrate, >=99% total lactose basis (GC)
UNII-J2B2A4N98G component WSVLPVUVIUVCRA-KPKNDVKVSA-N
4-O-beta-D-Galactopyranosyl-alpha-D-glucopyranose monohydrate
alpha-D-Glucopyranose, 4-O-beta-D-galactopyranosyl-, hydrate
alpha-Lactose monohydrate, BioXtra, >=99% total lactose basis (GC)
alpha-Lactose monohydrate, suitable for cell culture, BioReagent
66857-12-3


 

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