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Specifications
| Grade: | USP43 |
| Appearance: | White free-flowing powder |
| Optical rotation: | +54.4° to +55.9° |
| Solubility: | Freely but slowly soluble in water, practically insoluble in alcohol |
| Water: | 4.5% - 5.5% |
| Residue on ignition: | 0.1% max. |
| Identification: | A. Infrared absorption B. Thin-layer chromatographic |
| Clarity and color of solution: | A solution of 1g in 10mL of boiling water is clear and nearly colorless. Determine the absorbance of this solution at a wavelength of 400nm. The absorbance divided by the path length in centimeters is 0.04 max. |
| Loss on drying: | 0.5% max. |
| Protein and light-absorbing impurities: | 210–220 nm: 0.25 max. 270–300 nm: 0.07 max. |
| Acidity or alkalinity: | The solution is colorless, and 0.4 mL max of 0.1 N sodium hydroxide |
| Microbial limit: | The total aerobic microbial: 100 cfu/g max. The total combined molds and yeasts: 50 cfu/g max. Absence of Escherichia coli |
| Particle size: | 80 mesh |
Applications
1. Pharmaceutical Industry
Excipient in tablet and capsule formulations: Lactose monohydrate is one of the most commonly used filler and binder agents in solid oral dosage forms.
Diluent: It adds bulk to formulations, especially when the active pharmaceutical ingredient (API) is potent or present in small amounts.
Carrier in dry powder inhalers (DPIs): Its good flow and aerosolization properties make it suitable as a carrier in pulmonary drug delivery systems.
Stabilizer: It helps maintain the stability and integrity of drugs during manufacturing and storage.
2. Food and Beverage Industry
Sweetener and texturizer: Lactose monohydrate is used in baked goods, confectionery, and dairy-based beverages to improve taste and texture.
Fermentation substrate: Used as a carbohydrate source in the production of yogurt, cheese, and probiotic drinks.
Nutritional additive: Provides energy and supports gut health through fermentation by beneficial microbes.
3. Nutritional Supplements
Used as a filler or carrier in vitamins, minerals, and nutraceutical formulations.
4. Cosmetic Industry
Utilized as a gentle exfoliant and moisturizing agent in skincare products.
Acts as a stabilizer and texture enhancer in creams and lotions.
Benefits
1. Excellent Physical Properties
Fine, free-flowing powder with good compressibility and binding ability.
High solubility in water, facilitating formulation versatility.
2. Non-reactive and Safe
Generally recognized as safe (GRAS) by regulatory agencies.
Inert and non-toxic, making it compatible with a wide range of APIs.
3. Enhances Product Quality
Improves tablet hardness, uniformity, and disintegration profile.
Supports consistent drug release and bioavailability.
4. Cost-Effective and Abundant
Derived from abundant natural sources (milk), making it economical.
Readily available in pharmaceutical and food-grade quality.
5. Supports Controlled Release
Can be used in controlled-release formulations due to its crystalline nature and water content.
Conclusion
Lactose monohydrate (CAS 5989-81-1) is a versatile and widely used excipient and ingredient in pharmaceutical, food, and cosmetic industries. Its excellent physical and chemical properties, combined with safety and cost-effectiveness, make it indispensable for tablet manufacturing, flavor enhancement, and nutritional supplementation. Whether as a filler, sweetener, or carrier, lactose monohydrate continues to play a critical role in improving product quality and performance.
