Pharmaceutical Chemistry

Lactose Monohydrate

Formula: C12H22O11·H2O GOST/CAS: CAS 64044-51-5

Lactose Monohydrate (Pharmaceutical Grade) is a natural carbohydrate consisting of crystalline lactose monohydrate (milk sugar). In the pharmaceutical industry, it serves as an indispensable excipient. It features excellent compressibility, chemical stability, a neutral taste, and ideal compatibility with most active pharmaceutical ingredients (APIs). It is widely utilized as a high-quality filler and binder in the manufacturing of solid and powder dosage forms.

Applications

Tablets and Capsules Production: Used as a primary filler (diluent) and binding agent in direct compression, as well as wet and dry granulation. It ensures precise dosing of APIs and the required mechanical strength of the tablets.

Powders and Dry Suspensions: Applied as a bulking agent and diluent for dry medical blends, sachets, and pediatric powder formulations, ensuring uniform distribution of micro-dosed active substances.

Carrier for Inhalers (DPI): Special micronized grades of lactose act as an ideal carrier-vehicle for delivering fine-particle drug substances into the respiratory tract via dry powder inhalers.

Food and Dietary Industry: Used as a nutrient medium for probiotics, a component in infant formulas, and a taste and texture stabilizer in specialized dietary products.

Key Advantages

Ideal Technological Properties: Features excellent flowability (pourability) and compressibility, minimizing equipment wear and ensuring consistent tablet weight and density.

High Chemical Purity: Fully complies with the stringent requirements of leading global pharmacopoeias (Ph.Eur., USP/NF, JP). It does not undergo undesirable reactions with active components.

Controlled Particle Size: Available in various mesh sizes and fractions (from fine powder for granulation to coarse particles for direct compression), allowing selection of the optimal grade for any manufacturing process.

Biological Safety: A natural, biodegradable, and non-toxic product. It has low hygroscopicity, which extends the shelf life and maintains the stability of finished dosage forms.

Storage & Transportation

Store in dry, clean, and well-ventilated warehouses, isolated from heat sources and foreign odors, in tightly closed original packaging.
Recommended temperature range: from +5°C to +25°C with relative air humidity not exceeding 60% (the product is sensitive to high humidity).
Avoid exposure to direct sunlight and mechanical damage to the packaging.
Transportation can be carried out by all types of covered transport in accordance with cargo transportation rules that guarantee protection against moisture and contamination. The product is not classified as a dangerous good.
Shelf Life: 2–3 years from the date of manufacture (depending on the manufacturer's specification).

Technical Specifications

Appearance White or almost white crystalline powder, odorless, with a slightly sweet taste

Molecular Weight 360.3 g/mol

Assay (Main Substance) ≥ 99.5%

Water Content (Karl Fischer) 4,5% - 5,5%

Solubility (at 20°C) Freely soluble in water, practically insoluble in 96% ethanol

Acidity or Alkalinity Solution is neutral (complies with pharmacopoeia standards)

Sulfated Ash ≤ 0,1%

Supply info

Multi-wall paper bags with a hermetic polyethylene inner liner, 25 kg net weight.
Supplied on Euro-pallets secured with protective stretch/shrink wrap to prevent moisture ingress.

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