Search
the marketplace
through 230,000 Chemicals and Raw Ingredients
through 8,000+ Supplier owned storefronts
company tower banner
Roquette Company Logo

SOLUTAB® A Croscarmellose Sodium - Pharma

1 of 3 products in this brand
SOLUTAB® Croscarmellose sodium is used in pharmaceutical and nutraceutical applications as a superdisintegrant for various oral dosage forms. Applications Swallowable tablets Orally dispersible tablets Hard capsules Blends Granules Pellets premix Benefit Efficient disintegration at low use level Features Crosslinked carboxymethyl cellulose sodium Three grades are available Disintegration performance is obtained through the wicking and swelling capacity that can be maximized via the selection of its origin (wood or cotton) Can be adapted to wet and dry granulation or direct compression processes

Chemical Name: Croscarmellose Sodium

Functions: Disintegrant

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), FDA IID, FSSAI, FSSC 22000, Halal, ISO 9001, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), United States Pharmacopeia (USP)

Labeling Claims: BSE-free, Halal, Kosher, TSE-free, Vegan

Synonyms: E468, Sodium Croscarmellose

Technical Data SheetSafety Data Sheet

Knowde Enhanced TDS

Identification & Functionality

Chemical Name

Croscarmellose Sodium

Pharma & Nutraceuticals Functions

Disintegrant

CAS No.
74811-65-7
EC No.
629-739-2
Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Binders & Disintegrants

Features & Benefits

Labeling Claims

BSE-free,

Halal,

Kosher,

TSE-free,

Vegan

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Capsules,

Granules,

Orally Disintegrating Tablets (ODTs),

Powder & Powder Blends,

Tablets

Manufacturing Technology

Direct Compression,

Wet Granulation

Use Level
0.5 - 5.0%

Properties

Physical Form

Powder,

Solid

Appearance
White fine powder
Typical Properties
ValueUnitsTest Method / Conditions
Water Contentmax. 6 - 10%—
Ethanol Contentmax. 0.5%—
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Degree of Substitution0.60 - 0.85——
Loss on Dryingmax. 10.0%—
pH5.0 - 7.0——
Residue on Ignition14.0 - 28.0%—
Retained on 200 Mesh (75 micron)max. 10.0%—
Settling Volume10.0 - 30.0ml—
Sodium Chloride and Sodium Glycolate Contentmax. 0.5%—
Water Soluble Substances1.0 - 10.0%—
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliAbsentper gramPlate count
Pseudomonas aeruginosaAbsentper gram—
SalmonellaAbsentper 10g—
Staphylococcus aureusAbsentper gram—
Total Aerobic Microbial Countmax. 1000CFU/gPlate count
Total Yeasts and Moulds Countmax. 100CFU/g—

Regulatory & Compliance

Certifications & Compliance

European Pharmacopeia (Ph. Eur.),

FDA IID,

FSSAI,

FSSC 22000,

Halal,

ISO 9001,

Japan Pharmacopeia (JP),

Kosher,

National Formulary (NF),

United States Pharmacopeia (USP)

Chemical Inventories

AICS (Australia),

IECSC (China),

NZIoC (New Zealand),

PICCS (Phillipines),

TCSI (Taiwan)

Grade

Pharma Grade

Conformity

Complies with the current USP/NF and EP requirements.

Technical Details & Test Data

Innovation Hub
Innovation Hub by Roquette
Looking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.

Packaging & Availability

Packaging Information
  • ROQ Product Code: 106101
  • Article (SKU) Code: 106101552
  • Package Size & Type: 25 kg lined cardboard box

Storage & Handling

Storage and Handling

Store in dry area, in well-closed containers.