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alpha-Lactose monohydrate is an important food sweetener.
Alpha-D-Lactose monohydrate is the crystalline form of milk sugar, a natural disaccharide composed of glucose and galactose.
Its primary uses are:
Pharmaceutical: As a fundamental filler or diluent in tablets and capsules.
Food Industry: A common ingredient in infant formula, baked goods, and confectionery.
Industrial: A carrier in food flavorings and spices.
In medicine, it is an inert bulk agent that helps form tablets of the right size and consistency for accurate dosing. It is not an active drug itself.
Items | Specifications | Results |
Appearance | White or almost white,Crystalline powder. | Complies |
Solubility | Freely but lowly soluble in water,practically insoluble in ethanol(96 per cent). | Complies |
The infrared absorption spectrum of the sample is concordant with that of the standard. | Complies | |
Identification B | The principal spot obtained from the Test solution corresponds in appearance and Rf value to that obtained from Standard solution A.The test is not valid unless the chromatogram obtained with Standard solution B shows four clearly discernible spots at the origin. | Complies |
Residue on ignition | NMT 0.1% | 0.03% |
Clarity and color of solution | The solution(1g in 10ml of boiling water) isclear and nearly colorless. Determine the absorbance of this solution at a wavelength of 400 nm.The absorbance divided by the path length,in cm,is NMT 0.04 | Complies
0.01 |
Optical rotation | +54.4°~ +55.9°,calculate on the anhydrous basis,determined at 20° | +55.2° |
Acidity or alkalinity | Add 0.3ml of phenolphthalein TS:the solution is colorless,and not more than 0.4ml of 0.1N sodium hydroxide is required to produce a pink ro red color. | Complies |
Loss on drying | Dry a sample at 80°for 2h. NMT 0.5% | 0.06% |
Water | 4.5%~5.5% | 4.9% |
Protein and light-absorbing impurities | 210-220 nm:NMT 0.25 270-300 nm:NMT 0.07 | 0.03 0.01 |
TAMC(cfu/g) | <100 | <10 |
Molds and Yeasts(cfu/g) | <50 | <10 |
Escherichia coli.(/10g) | absence | Not detected |
Conclusion | The product conforms to the above specifications. | |
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| Product parameters | |
| Cas number: | 5989-81-1 |
| Appearance: | White powder |
| Purity: | 98.0% - 102.0% |
| Package details: | 25kg/bag |
| Brand: | Fortunachem |
CAS Number: 5989-81-1
Molecular Formula: C₁₂H₂₂O₁₁·H₂O (anhydrous lactose: C₁₂H₂₂O₁₁; monohydrate adds 1 H₂O)
Molecular Weight: 360.31 g/mol (monohydrate); 342.30 g/mol (anhydrous)
Physical Properties:
White, odorless, crystalline powder with a mild sweet taste (≈20% sweetness of sucrose).
Soluble in water (≈19 g/100 mL at 20°C), sparingly soluble in ethanol; stable under normal storage conditions (hygroscopic if exposed to high humidity).
Melting point: Decomposes at ~140°C (loses water of crystallization); anhydrous form melts at ~202°C.
Tablet Diluent/Filler: The most common use – it provides bulk to tablets (e.g., 50-90% of tablet weight for low-dose APIs like aspirin, antibiotics, or antihypertensives), enabling uniform mixing and consistent tablet size/weight. Its crystalline structure supports good compression, producing hard, stable tablets with minimal capping/lamination.
Capsule Filler: Used to fill hard gelatin capsules, especially for powdered or granular APIs, to achieve precise dosing and improve flow during capsule filling.
Dry Powder Inhaler (DPI) Carrier: Blended with micronized APIs (e.g., asthma medications like salbutamol) to enhance aerosolization and lung deposition.
Lyophilization (Freeze-Drying) Aid: Added to formulations for injectables to protect APIs from degradation during freeze-drying and improve reconstitution stability.
Binder/Disintegrant: In wet granulation processes, it acts as a mild binder (via hydration) and aids tablet disintegration in the gastrointestinal tract (dissolves slowly in water, facilitating API release).
Dairy Products: Used to standardize lactose levels in milk, yogurt, ice cream, and cheese, improving texture, sweetness, and freeze-thaw stability.
Baked Goods: Added to bread, cakes, and pastries to enhance browning (via Maillard reaction), retain moisture, and extend shelf life; also used as a sweetener in low-sugar formulations.
Infant Formula: A key component (mimicking human milk lactose) to provide energy and support gut health in infant nutrition.
Functional Foods: Incorporated into protein bars, meal replacements, and dietary supplements as a carbohydrate source and bulking agent.
Used in skincare (moisturizers, creams) and oral care (toothpaste, mouthwash) products as a humectant (retains moisture), mild sweetener, or bulking agent. It is non-irritating and compatible with most cosmetic ingredients, making it suitable for sensitive skin formulations.
Cell Culture Media: A carbon source for microbial and mammalian cell culture (e.g., in vaccine production, biopharmaceutical manufacturing).
Chromatography Standards: High-purity grades serve as reference materials for analytical chemistry (HPLC, GC) calibrations.
Grades: Multiple purity grades are available (e.g., Ph.Eur., USP/NF, Food Grade) – pharmaceutical grades require low heavy metal (<10 ppm) and microbial counts, while food grades meet FDA/EFSA safety standards.
Handling: Hygroscopic – store in a cool, dry place (20-25°C, <60% RH) to prevent clumping or conversion to anhydrous lactose.
Safety: Generally recognized as safe (GRAS) by the FDA; lactose-intolerant individuals lack lactase (the enzyme to digest lactose) and may experience gastrointestinal discomfort (bloating, diarrhea) upon ingestion.



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