لاکتوز مونوهیدرات
Formula | C12H22O11 *H2O |
Chemical formula | C12H22O11 *H2O |
Molar mass | 360.32 g/mol |
CAS number | 10039-26-6 |
HS Code | 17021100 |
EC number | 200-559-2 |
Storage | at +15 °C to +25 °C |
SDS | available |
RTECS | OD9625000 |
Odour | odourless |
Form | solid |
Color | white |
p H value | 4.0 – 6.0(40 g/l 25°C) |
Solubility in water | freely soluble (20°C) |
Melting point | 223 °C |
Description | Conforms | ||
Identification | Conforms | ||
Solubility | Conforms | ||
Loss on ignition | ≤ | 0/1 | % |
Heavy metals | ≤ | 5.0 | ppm |
Clarity & color of solution | Conforms | ||
Loss on drying | ≤ | 0/5 | % |
Acidity & alkalinity | ≤ | 0/3 | ml |
Optical rotation | +54.4 to +55.9 | ° | |
Protein & light absorbing impurity | Conforms | ||
Water determination | 4.5 to 5.5 | % |
Lactose monohydrate is an organic compound composed of the disaccharide sugar lactose with one molecule of water, widely used as a filler and stabilizer in pharmaceutical formulations and food products.
🏭⚗️ Production
Lactose monohydrate is produced industrially from whey, a byproduct of cheese production. The whey is filtered, concentrated, and crystallized to isolate lactose in its monohydrate form. In laboratory or pharmaceutical settings, controlled crystallization at low temperatures ensures high purity and consistent particle size.
🔬 Properties
It appears as a white crystalline powder, slightly sweet in taste, odorless, and soluble in water. Its chemical formula is C₁₂H₂₂O₁₁·H₂O, with a molar mass of approximately 360.31 g/mol. It is stable under normal conditions and commonly used due to its low hygroscopicity and good compressibility.
🧪 Applications
Lactose monohydrate is primarily used as an excipient in tablet and capsule formulations in the pharmaceutical industry. It is also used in dry powder inhalers, infant formula, and processed foods as a stabilizer and bulking agent.
⚠️ Safety
Lactose monohydrate is generally recognized as safe (GRAS). However, it should not be used by individuals with lactose intolerance. It is non-toxic, but inhalation of dust should be avoided. Store in a cool, dry place in well-sealed containers.