CROSCARMELLOSE SODIUM POWDER

CROSCARMELLOSE SODIUM POWDER Specification

pH (1% w/v Dispersion)
5.0 - 7.0

Identification
Positive for sodium and carboxymethylcellulose

Microbial Limits
Total bacterial count NMT 1000 cfu/g, Yeast & molds NMT 100 cfu/g

Sodium Content
6.5% - 8.0%

Assay (On Dry Basis)
85.0% - 100.5%

Loss on Drying
Not more than 10.0%

Usage
Used as a super disintegrant in pharmaceutical formulations

Appearance
White or off-white, free-flowing powder

Heavy Metals
Not more than 10 ppm

Solubility
Insoluble in most organic solvents, dispersible in water

Storage Condition
Store in a cool, dry place in tightly closed containers

Particle Size
Not more than 2% retained on 60 mesh

Bulk Density
0.40 - 0.60 g/cm3

Shelf Life
3 years when properly stored

CROSCARMELLOSE SODIUM POWDER Trade Information

Minimum Order Quantity
25 Kilograms

FOB Port
NAHVA SHEVA

Payment Terms
Cash Advance (CA), Cash in Advance (CID)

Supply Ability
1000 Kilograms Per Day

Delivery Time
2 Days

Sample Available
No

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

Main Domestic Market
All India

About CROSCARMELLOSE SODIUM POWDER

Croscarmellose Sodium is a cross-linked sodium carboxymethyl cellulose widely used as a superdisintegrant in pharmaceutical tablet formulations. It rapidly absorbs water and swells, enabling fast tablet disintegration and improved drug dissolution. Arrown Enterprise provides high-quality Croscarmellose Sodium with consistent performance and excellent functionality.

Key Functions and Usage

Croscarmellose Sodium Powder is predominantly used as a super disintegrant in pharmaceutical tablets and capsules. Its rapid swelling ability in the presence of water helps tablets disintegrate quickly upon ingestion, ensuring efficient release of active ingredients. Its wide usage makes it a critical excipient in a variety of oral solid dosage forms.

Quality and Safety Standards

Every batch is tested to meet stringent microbial standards-total bacterial count does not exceed 1000 cfu/g and yeast and molds stay under 100 cfu/g. Heavy metal content is limited to 10 ppm, ensuring the powder's safety for pharmaceutical applications. These specifications make it a reliable ingredient for regulated markets.

Storage and Longevity

Proper storage extends the shelf life of Croscarmellose Sodium Powder to three years. To maintain its free-flowing property and integrity, store it in a cool, dry place, sealed tightly to prevent moisture ingress and contamination. Adhering to recommended storage conditions preserves the product's efficacy and safety.

FAQ's of CROSCARMELLOSE SODIUM POWDER:

Q: How should Croscarmellose Sodium Powder be stored to maximize its shelf life?

A: The powder should be kept in a tightly closed container in a cool, dry place. This helps preserve its integrity and ensures a shelf life of up to three years.

Q: What is the primary use of Croscarmellose Sodium Powder in pharmaceuticals?

A: It acts as a super disintegrant in tablet and capsule formulations, facilitating the rapid breakup of the dosage form in the digestive tract for effective release of active ingredients.

Q: What benefits does using Croscarmellose Sodium Powder provide in tablet manufacturing?

A: It promotes faster disintegration and dissolution of tablets, leading to improved bioavailability of drugs and more predictable therapeutic outcomes.

Q: Where can this powder be effectively incorporated in pharmaceutical processes?

A: It can be added during both the wet granulation and direct compression steps of tablet production and in the preparation of capsules, making it versatile for different formulation methods.

Q: What are the safety specifications for microbial limits and heavy metals in this powder?

A: Each batch contains not more than 1000 cfu/g of total bacteria, under 100 cfu/g of yeast and molds, and heavy metals not exceeding 10 ppm, ensuring safety for pharmaceutical use.

Q: When is it most effective to add Croscarmellose Sodium Powder during the formulation process?

A: It can be introduced either intragranularly or extragranularly, depending on the required disintegration profile and the specific needs of the formulation.

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