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Lactose Monohydrate

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Lactose Monohydrate Specification

EINECS No
600-073-4

Ph Level
4.5 - 7.0 (10% solution)

Taste
Slightly sweet

Grade
Pharma Grade / Food Grade

Structural Formula
C12H22O11H2O

Storage
Store in a cool, dry place in tightly closed container

HS Code
17021100

Heavy Metal (%)
0.001%

Smell
Odorless

Moisture (%)
4.5% - 5.5%

Assay
98.0% - 102.0%

Molecular Formula
C12H22O11 H2O

Molecular Weight
360.31 g/mol

Water Solubility
Readily soluble in water

Shelf Life
36 months

Loss on Drying
5.0%

Chemical Name
Lactose Monohydrate

CAS No
10039-26-6

Usage
Pharmaceutical excipient, food additive, used in infant formula and tablets

Purity(%)
99.5% Min

Appearance
White crystalline powder

Application
Used as a diluent or filler in pharmaceutical tablets and capsules; food industry for confectionery, dairy, and bakery products

Lactose Monohydrate Trade Information

FOB Port
Mundra Port, Nhava Sheva

Payment Terms
Paypal, Letter of Credit (L/C), Western Union, Letter of Credit at Sight (Sight L/C), Telegraphic Transfer (T/T), Cash in Advance (CID), Cash Advance (CA)

Supply Ability
100 MT Per Month

Delivery Time
30 Days

Sample Policy
Within a certain price range free samples are available

Packaging Details
As Per Buyer Requirements

Main Export Market(s)
Australia, Eastern Europe, Middle East, Western Europe, Central America, Africa, South America, Asia, North America

Main Domestic Market
All India

Certifications
ISO, GMP, WHO, FDA, MSDS

About Lactose Monohydrate

Lactose (C12H22O11) is milk sugar. It is a disaccharide composed of one galactose and one glucose molecule. In the pharmaceutical industry, lactose is used to help form tablets because it has excellent compressibility properties. It is also used to form a diluent powder for dry-powder inhalations. Lactose may be listed as lactose hydrous, lactose anhydrous, lactose monohydrate, or lactose spray-dried.

Chemical Names:5989-81-1; Alpha-D-Lactose monohydrate; Alpha-Lactose monohydrate; Lactose monohydrate; Lactose, monohydrate; A-Lactose monohydrate

Molecular Formula: C12H24O12

Molecular Weight: 360.312 g/mol

Pharmaceutical and Food Applications

Lactose Monohydrate is highly regarded for its versatility as a diluent and filler in pharmaceutical tablets and capsules, ensuring uniform drug distribution. In the food sector, it is favored for its functional properties in confectionery, dairy, and bakery products. Its safety, purity, and consistent performance make it suitable for infant formula and other sensitive applications.

Quality, Safety, and Compliance

This product adheres to rigorous quality control standards, including limits on microbial content, heavy metals, and moisture. Being BSE/TSE-free and allergen-free, it aligns with international safety regulations. Its consistent particle size distribution and high solubility enhance both processing and end-product quality.

Packaging, Storage, and Shelf Life

Lactose Monohydrate is supplied in robust 25 kg fiber drums or bags to preserve integrity during storage and transit. The recommended storage is in a cool, dry environment within tightly closed containers, guaranteeing a shelf life of up to 36 months. Proper handling ensures the product retains its quality and performance for an extended period.

FAQs of Lactose Monohydrate:

Q: How is Lactose Monohydrate used in pharmaceutical and food industries?

A: Lactose Monohydrate serves as a diluent and filler in pharmaceutical tablets and capsules, promoting uniformity and ease of processing. In the food industry, it acts as a functional additive in products like confectionery, dairy, and baked goods, as well as an ingredient in infant formula due to its purity and safety profile.

Q: What are the key benefits of using Lactose Monohydrate?

A: Key benefits include its high purity (minimum 99.5%), excellent solubility in water, neutral odor and taste, and established safety profile (BSE/TSE and allergen free). Its consistent particle size allows for reliable formulation, making it suitable for sensitive applications in both pharma and food sectors.

Q: Where should Lactose Monohydrate be stored for optimal quality?

A: For best results, Lactose Monohydrate should be stored in a cool, dry location in tightly closed containers. This practice protects the ingredient from moisture and contaminants, preserving its shelf life and functional properties.

Q: What is the typical packaging for Lactose Monohydrate?

A: Lactose Monohydrate is usually packaged in 25 kg fiber drums or bags, ensuring safe transport and minimizing contamination risks. This packaging supports easy handling and storage for bulk users, such as manufacturers and suppliers.

Q: How does the manufacturing process ensure quality and safety?

A: The manufacturing process adheres to stringent standards for microbial counts, heavy metal content, and moisture control. Regular testing ensures compliance with international regulations, and the product is certified free from BSE/TSE and common allergens, making it fit for a wide range of applications.

Q: When does Lactose Monohydrate lose water and what is its melting point?

A: Lactose Monohydrate has a melting point of 202C, at which it also loses its crystalline water. This property is crucial for understanding its behavior during processing in high-temperature applications.

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