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SOLUTAB® A Croscarmellose Sodium - Pharma

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

Brand: SOLUTAB (1 products)

Chemical Name: Croscarmellose Sodium

CAS Number: 74811-65-7

Functions: Disintegrant

Manufacturing Technology: Direct Compression, Wet Granulation

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

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)

Synonyms: E468, Sodium Croscarmellose

Technical Data Sheet Safety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

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),
Pellets,
Powder & Powder Blends,
Sachets,
Stick,
Tablets
Manufacturing Technology: Direct Compression,
Wet Granulation
Use Level: 0.5 - 5.0%

Properties

Physical Form

Appearance

White fine powder

Typical Properties


	Value	Units	Test Method / Conditions
Water Content	max. 6 - 10	%
Ethanol Content	max. 0.5	%

Physico-Chemical Properties


	Value	Units	Test Method / Conditions
Degree of Substitution	0.60 - 0.85	-	-
Loss on Drying	max. 10.0	%	-
pH	5.0 - 7.0	-	-
Residue on Ignition	14.0 - 28.0	%	-
Retained on 200 Mesh (75 micron)	max. 10.0	%	-
Settling Volume	10.0 - 30.0	ml	-
Sodium Chloride and Sodium Glycolate Content	max. 0.5	%	-
Water Soluble Substances	1.0 - 10.0	%	-

Microbiological Values


	Value	Units	Test Method / Conditions
Escherichia coli	Absent	per gram	Plate count
Pseudomonas aeruginosa	Absent	per gram	-
Salmonella	Absent	per 10g	-
Staphylococcus aureus	Absent	per gram	-
Total Aerobic Microbial Count	max. 1000	CFU/g	Plate count
Total Yeasts and Moulds Count	max. 100	CFU/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
Quality Standards: ICH Q7
Conformity: Complies with the current USP/NF and EP requirements.

Technical Details & Test Data

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Packaging & Availability

Packaging Information

Article (SKU) Code: 5100002247
Package Size & Type: 25 KG CARBOARD BOX

Storage & Handling

Storage and Handling: Store in dry area, in well-closed containers.