Alpha-D-Lactose monohydrate

Alpha-D-Lactose monohydrate Basic information
Product Name:Alpha-D-Lactose monohydrate
Synonyms:alpha-D-Lactose Monohydrate, 99.5+%, 2-4% beta-isoMer;alpha-D-Lactose Monohydrate, USP/NF, Ph.Eur., JP 250GR;4-O-beta-D-Galactopyranosyl-alpha-D-glucopyranose monohydrate;LACTOSE MONOHYDRATE, a-(RG);Pharmatose 325;Pharmatose 50M;Pharmatose 90M;Pharmatose DCL 11
CAS:5989-81-1
MF:C12H24O12
MW:360.31
EINECS:611-913-4
Product Categories:medicine excipents
Mol File:5989-81-1.mol
Alpha-D-Lactose monohydrate Structure
Alpha-D-Lactose monohydrate Chemical Properties
Melting point 219 °C
alpha [α]D20+52.2~+52.8°
Boiling point 412.35°C (rough estimate)
density 1,53 g/cm3
RTECS OD9625000
refractive index 1.6480 (estimate)
storage temp. Inert atmosphere,Room Temperature
solubility H2O: soluble1M, clear, colorless
form neat
color White to Off-White
PHpH (50g/l, 25℃) : 4.0~6.0
Water Solubility Soluble in water.
Stability:Hygroscopic
InChIKeyWSVLPVUVIUVCRA-KPKNDVKVSA-N
CAS DataBase Reference5989-81-1(CAS DataBase Reference)
EPA Substance Registry System.alpha.-D-Glucopyranose, 4-O-.beta.-D-galactopyranosyl-, hydrate (1:1) (5989-81-1)
Safety Information
Hazard Codes Xi
Risk Statements 40-36/37/38
Safety Statements 24/25-36-26
WGK Germany 3
TSCA Yes
HS Code 17021100
MSDS Information
ProviderLanguage
ACROS English
SigmaAldrich English
ALFA English
Alpha-D-Lactose monohydrate Usage And Synthesis
Chemical PropertiesLactose occurs as white to off-white crystalline particles or powder. It 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.
Chemical PropertiesWhite powder
Usesalpha-D-Lactose monohydrate is used as a carrier and stabiliser of aromas, pharmaceutical products, Food industry.
DefinitionA sugar that occurs in many plants. It is extracted commercially from sugar cane and sugar beet. Sucrose is a disaccharide formed from a glucose unit and a fructose unit. It 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.
Production MethodsA 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.
Pharmaceutical ApplicationsSpray-dried lactose is widely used as a binder, filler-binder, and flow aid in direct compression tableting.
Biochem/physiol Actionsalpha-Lactose is the primary sugar present in milk and the main energy source to a newborn mammalian through its mother′s milk. It 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.
SafetyLactose is widely used in pharmaceutical formulations as a diluent 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 enzyme lactase.
storageSpray-dried lactose should be stored in a well-closed container in a cool, dry place.
IncompatibilitiesLactose is a reducing sugar. The amorphous lactose, which is the most reactive form of lactose present in spray-dried lactose, will interact more readily than conventional crystalline grades. Typical reactions include the Maillard reaction with either primary or secondary amines.
Alpha-D-Lactose monohydrate Preparation Products And Raw materials
N-Acetyl-D-Glucosamine L-xylose Glycyrrhizic acid Alitame Isomalt D-Xylose Saccharin MONELLIN Thickening agent Sulfamic acid EMULSIFIER EDIBLE LACTOSE LACTOSE, MONOHYDRATE Lactose D(+)-Glucose D-Glucose monohydrate ALPHA-LACTOSE, MONOHYDRATE D-Lactose monohy Lactose Monohydrate

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