Lactose, Lactose Monohydrate, Anhydrous Lactose, Milk Sugar, 63-42-3

LACTOSE (LACTOSE MONOHYDRATE AND ANHYDROUS LACTOSE)

Lactose / Milk Sugar / Lactose Monohydrate / Anhydrous Lactose / Süt Şekeri
CAS Numbers: 63-42-3 (Monohydrate); 64044-51-5 (Anhydrous)
EC Numbers: 200-559-2 (Monohydrate); 159220-7 (Anhydrous)

SECTION 1: PRODUCT IDENTIFICATION AND CHEMICAL IDENTITY

Lactose (milk sugar) is a naturally occurring disaccharide found in mammalian milk, formed by the combination of one glucose and one galactose molecule linked by a β-1,4 glycosidic bond. It exists in two primary forms: Lactose Monohydrate (CAS 63-42-3) , which contains one molecule of water of crystallization, and Anhydrous Lactose (CAS 64044-51-5) , which contains no water of crystallization and is preferred for moisture-sensitive formulations.

SECTION 2: SYNONYMS AND OTHER NAMES

SECTION 3: CHEMICAL STRUCTURE

3.1. Molecular Structure

Lactose is a disaccharide formed by the linkage of β-D-galactose and α/β-D-glucose units through a β-1,4-glycosidic bond. The molecule is a reducing sugar (contains a free anomeric carbon). The monohydrate form contains one molecule of water of crystallization in its crystal lattice.

Structural Formula:

        CH₂OH                CH₂OH
         |                     |
         O                     O
        / \                   / \
       /   \                 /   \
      /     \               /     \
     H       H             H       H
     |       |             |       |
     C       C             C       C
    / \     / \           / \     / \
   /   \   /   \         /   \   /   \
  H     OH OH    H       H     OH OH    H
   \   /   \   /         \   /   \   /
    \ /     \ /           \ /     \ /
     C - O - C             C - O - C
     |       |             |       |
     H       OH            H       OH

Simplified Representation:
β-D-Gal-(1→4)-D-Glc

3.2. Molecular Formula and Weight

3.3. Key Structural Features

SECTION 4: LACTOSE MONOHYDRATE VS. ANHYDROUS LACTOSE COMPARISON

SECTION 5: TYPES AND GRADES OF LACTOSE

5.1. Pharmaceutical Grades (USP / Ph.Eur.)

5.2. Food Grades

SECTION 6: PHYSICAL AND CHEMICAL PROPERTIES

SECTION 7: SOLUBILITY PROFILE

SECTION 8: CHEMICAL PROPERTIES AND REACTIVITY

SECTION 9: PRODUCTION METHODS

9.1. Lactose Monohydrate Production

9.2. Anhydrous Lactose Production

SECTION 10: LACTOSE INTOLERANCE

10.1. Definition and Cause

10.2. Types of Lactose Intolerance

SECTION 11: APPLICATIONS AND INDUSTRIAL USES

11.1. Pharmaceutical Industry (Most Important Application)

11.2. Food Industry

11.3. Other Applications

SECTION 12: COMPARISON WITH ALTERNATIVE SUGARS

SECTION 13: SECTORAL SUITABILITY TABLE

SECTION 14: TOXICOLOGICAL PROFILE

SECTION 15: GHS CLASSIFICATION

GHS Classification (Not Classified as Hazardous):

Signal Word: None

Hazard Pictograms: None

Hazard Statements (H-Codes): None

Safety Phrases (Historically):

SECTION 16: PRECAUTIONARY STATEMENTS (P-CODES)

SECTION 17: FIRST AID MEASURES

SECTION 18: FIRE-FIGHTING MEASURES

SECTION 19: ACCIDENTAL RELEASE MEASURES

SECTION 20: STORAGE AND SHELF LIFE

SECTION 21: PACKAGING OPTIONS

SECTION 22: TRANSPORT INFORMATION

SECTION 23: REGULATORY INFORMATION

SECTION 24: NUTRITIONAL AND HEALTH INFORMATION

SECTION 25: QUICK REFERENCE TABLE

SECTION 26: CRITICAL NOTICES AND BEST PRACTICES

CRITICAL NOTICES:

1. CAS Number Correction: The correct CAS number for lactose monohydrate is 63-42-3. The CAS number 14641-93-1 belongs to lactobionic acid or another derivative.

2. Molecular Formula: Lactose monohydrate has the formula C₁₂H₂₂O₁₁·H₂O and contains one molecule of water of crystallization. Anhydrous lactose (64044-51-5) has the formula C₁₂H₂₂O₁₁.

3. Form Selection: Lactose monohydrate is suitable for general applications. Anhydrous lactose is preferred for formulations containing moisture-sensitive active pharmaceutical ingredients (APIs).

4. Lactose Intolerance: May cause digestive issues (bloating, gas, diarrhea, abdominal pain) in lactose-intolerant individuals.

5. Milk Allergy: Caution should be exercised in individuals with milk allergy.

6. Moisture Sensitivity: Anhydrous lactose is highly sensitive to moisture. It should be stored under inert atmosphere (nitrogen) to prevent moisture absorption and conversion to monohydrate.

7. Reducing Property: Lactose is a reducing sugar. It can undergo Maillard reaction (browning) with amino-containing ingredients; caution should be taken in formulations.

8. Heat Sensitivity: Caramelizes at high temperatures. Care should be taken during heat processing.

9. Dust Control: Lactose dust may be inhaled and cause respiratory irritation. Dust control and adequate ventilation should be provided.

10. Purity: High-purity lactose meeting USP/Ph.Eur. standards should be used for pharmaceutical applications.

BEST PRACTICE RECOMMENDATIONS:

• Formulation Selection: Use monohydrate for wet granulation; use anhydrous lactose for direct compression and moisture-sensitive formulations.

• Storage: Store in a cool, dry, and well-ventilated area in tightly closed original packaging. Use inert atmosphere (nitrogen) for anhydrous lactose.

• Personnel Protection: Use dust mask, protective goggles, and gloves when handling powder.

• Moisture Control: Ensure moisture control in the production area when using anhydrous lactose.

• Quality Assurance: Perform loss on drying, optical rotation, and particle size distribution tests for each batch.

• Labeling: Clearly indicate lactose content on product labels for lactose-intolerant individuals.

• Packaging: Use moisture-protected packaging; for anhydrous lactose, use inert atmosphere packaging.

LEGAL DISCLAIMER:

The information provided in this document is based on our current knowledge and experience and is presented in good faith; however, as all conditions of use are beyond our control, it does not constitute a binding specification or warranty. This Technical Data Sheet is for informational purposes only. Users are obligated to test the suitability of the product for their own applications. For complete safety, storage, handling, transport, waste, and regulatory compliance information, the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier must be consulted.