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Lactose

CAS No.63-42-3
Chemical Name:Lactose
CBNumber:CB8710411
Molecular Formula:C12H22O11
Formula Weight:342.3
MOL File:63-42-3.mol

Lactose Property

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 Mildly sweet taste.
optical activity Alpha form +85.0 → +52.6 Beta form +34.9 → +55.4
Water Solubility 5-10 g/100 mL at 20 ºC
BRN 93796
Stability Stable. Incompatible with strong oxidizing agents.
LogP -3.391 (est)
CAS DataBase Reference 63-42-3(CAS DataBase Reference)
FDA 21 CFR 168.122; 169.179; 310.545
Substances Added to Food (formerly EAFUS) LACTOSE
EWG's Food Scores 1
NCI Dictionary of Cancer Terms lactose
FDA UNII 3SY5LH9PMK
NIST Chemistry Reference D-Glucose, 4-o-«beta»-D-galactopyranosyl-(63-42-3)
EPA Substance Registry System Lactose (63-42-3)
UNSPSC Code 41116107
NACRES NA.24

Safety

Safety Statements :24/25
WGK Germany :2
RTECS :OD9625000
TSCA :Yes
HS Code :17021100
Hazardous Substances Data :63-42-3(Hazardous Substances Data)

Hazard and Precautionary Statements (GHS)

Symbol(GHS)
Signal word
Hazard statements
Precautionary statements

Lactose Price More Price(5)

Brand: Sigma-Aldrich(India)
Product number: PHR1025
Product name : Lactose, Anhydrous
Purity: Pharmaceutical Secondary Standard; Certified Reference Material
Packaging: 1G
Price: ₹9983.25
Updated: 2022/06/14
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Brand: Sigma-Aldrich
Product number: 17814
Product name : Lactose
Purity: tested according to Ph. Eur.
Packaging: 1KG
Price: ₹15975.75
Updated: 2022/06/14
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Brand: Sigma-Aldrich(India)
Product number: 17814
Product name : Lactose
Purity: tested according to Ph. Eur.
Packaging: 1KG
Price: ₹15975.75
Updated: 2022/06/14
Buy: Buy

Brand: ALFA India
Product number: ALF-J66376-A1
Product name : Thermo Scientific™ D-Lactose
Purity:
Packaging: 1kg
Price: ₹13047
Updated: 2022/05/26
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Brand: ALFA India
Product number: ALF-J66376-36
Product name : Thermo Scientific™ D-Lactose
Purity:
Packaging: 500g
Price: ₹6677
Updated: 2022/05/26
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Lactose Chemical Properties,Usage,Production

Chemical Properties white crystals or powder
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.
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.
Uses D-Lactose is used for the culture of lactic acid metabolizing bacteria, lactic acid bacteria. D-Lactose is used to identify and characterized galectins.
Uses A disaccharide sugar present in milk.
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.
Definition A sugar found in milk. It is a disaccharide composed of glucose and galactose units.
General Description 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.
Air & Water Reactions Water soluble.
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.
Health Hazard ACUTE/CHRONIC HAZARDS: Lactose should be considered toxic.
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.