Croscarmellose Sodium

Product Overview

Croscarmellose Sodium is used in pharmaceutical formulations as a superdisintegrant, particularly in solid dosage forms such as tablets and capsules. It is effective at low concentrations and is compatible with a wide range of APIs and excipients.

Product Type: Pharmaceutical Excipient

Chemical Name Cross-linked Carboxymethylcellulose Sodium

Chemical Formula (C8H16NaO8)n

CAS Number 74811-65-7

Molecular Weight Approx. 240.20 g/mol

Application Role Superdisintegrant in tablets and capsules to enhance disintegration and dissolution

Regulatory Compliance IP / BP / USP / EP

Manufacturing Suitability Suitable for direct compression and wet granulation; compatible with high-speed tablet presses

Storage Conditions Store in a cool, dry place; protect from excessive heat and moisture; recommended temperature 15–30°C (59–86°F)

Certifications FDA GRAS, ISO 9001, GMP (depending on manufacturer)

Availability Commercially available in powder form from multiple pharmaceutical excipient suppliers globally

HS Code 3912.90.90

Excipient Technical Profile

Appearance White to off-white free-flowing powder

Bulk Density 0.40 – 0.65 g/cm³

Solubility Insoluble in water, ethanol, and most organic solvents

Typical Applications

Enhances tablet disintegration and dissolution
Suitable for both direct compression and wet granulation processes
Promotes rapid breakdown of capsule contents in the gastrointestinal tract
Commonly used in dietary supplements and herbal tablets

Key Benefits

Rapid disintegration

Versatile processing compatibility

Effective at low concentrations

Non-ionic and inert

Highly swellable

Regulatory acceptance

Safety Info

Croscarmellose Sodium – Safety Information

Toxicological Profile

Non-toxic when used within recommended concentrations
Considered safe for human consumption as a pharmaceutical excipient
Not absorbed systemically and passes through the gastrointestinal tract unchanged

Inhalation Risk

May cause mild respiratory irritation if inhaled as a fine powder
Use appropriate dust control measures during handling

Skin and Eye Contact

Generally non-irritating to skin
May cause mild mechanical irritation to eyes; rinse with water if contact occurs

Handling Precautions

Use PPE such as gloves, goggles, and dust masks when handling bulk powder
Ensure adequate ventilation in processing areas

Environmental Impact

Not expected to pose environmental risks in normal use
Biodegradable and non-toxic to aquatic life

Why Choose Salius Pharma?

GMP-Compliant Quality: Stringent QC to ensure consistent, premium-grade excipients.
Regulatory Support: Comprehensive documentation available.
Reliable Supply: Global distribution with timely delivery.
Technical Expertise: Dedicated formulation support and customer service.
Customized Solutions: Flexible packaging and product grades tailored to your needs.

FAQs

Yes. Pharmaceutical-grade Croscarmellose Sodium is exported globally in compliance with international regulatory standards.

Yes. Samples are provided free of charge for evaluation, with CoA and technical documentation.

Yes. Support includes CTD/eCTD dossiers, DMF filing, and responses to regulatory authority queries.

Yes. COA, MSDS, DMF, Stability Data, COS, Impurity Profile, BA/BE Studies, and WHO-GMP/ISO certificates are available upon request.

Supplied to over 40 countries including the USA, Germany, UK, Brazil, UAE, South Africa, Canada, and Southeast Asia.

You can contact export@saliuspharma.com or submit an inquiry through the website Visit On www.saliusapi.com Responses are provided within 24–48 hours.

What You Receive with Every Order

At Salius Pharma, we deliver more than just an excipient — we deliver confidence, compliance, and quality. Every shipment is thoughtfully prepared to meet international regulatory standards and your exact specifications.

What’s Included:

✔ Premium Product:

High-purity Croscarmellose Sodium
Packaged for maximum stability and protection
Moisture-resistant, tamper-evident sealing

✔ Custom Packaging Options:

Tailored drum sizes, blister packs, or bottle formats
Designed to meet your operational needs and dosage requirements

Place an Order or Request a Quote from Salius Pharma

Looking to source Croscarmellose Sodium or other high-quality pharmaceutical products?
We’re here to help.
Whether you need Active Pharmaceutical Ingredients (APIs), excipients, or regulatory support, our team is ready to provide reliable, compliant, and cost-effective solutions tailored to your market needs.

Get in Touch

Email: export@saliuspharma.com
Call / WhatsApp: +91 84258 80640 / +91 84258 80643
Landline: +91 22 49700 601 / +91 22 44503 148
Corporate Office: 3104–3106, Plan S Business Park, Nerul MIDC Opp. Dr. D.Y. Patil Stadium, Navi Mumbai – 400706, Maharashtra, India

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Any patented products are excluded from our offerings in regions where such patents are currently in force.

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