SOLUTAB® A Croscarmellose Sodium - Pharma
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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
Function: Disintegrant
Certifications & Compliance: Japan Pharmacopeia (JP), FDA IID, Kosher, European Pharmacopeia (Ph. Eur.), Halal, FSSC 22000, United States Pharmacopeia (USP), FSSAI, ISO 9001
Labeling Claims: BSE-free, Vegan, TSE-free, Halal, Kosher
Synonyms: E468, Sodium Croscarmellose
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TypeDocument Name
Technical Data Sheet
SOLUTAB® A Technical Data Sheet
SOLUTAB® A Technical Data Sheet
Technical Data SheetSafety Data Sheet
SOLUTAB® A Croscarmellose Sodium - Pharma Safety Data Sheet (US - EN)
SOLUTAB® A Croscarmellose Sodium - Pharma Safety Data Sheet (US - EN)
Safety Data SheetKnowde Enhanced TDS
Identification & Functionality
Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
EC No.
Technologies
SOLUTAB® A Croscarmellose Sodium - Pharma Features & Benefits
Applications & Uses
Markets
Manufacturing Technology
Properties
Physico-Chemical Properties
| Value | Units | Test Method / Conditions | |
| Degree of Substitution | 0.60 - 0.85 | - | - |
| Ethanol Content (Residual Solvent) | max. 0.50 | % | - |
| 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
Grade
Conformity
Complies with the current USP/NF and EP requirements.
Technical Details & Test Data
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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.
SOLUTAB® A Croscarmellose Sodium - Pharma
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