Ac-Di-Sol® SDW - 802

1 of 2 products in this brand
Ac-Di-Sol® SDW - 802 is a versatile ingredient suitable for capsules, granules, and orally disintegrating tablets (ODTs). Employing wet granulation, it serves as a disintegrant and immediate release agent in pharmaceutical and nutraceutical formulations.

Chemical Name: Croscarmellose Sodium

CAS Number: 74811-65-7

Dosage Form: Capsules, Granules, Orally Disintegrating Tablets (ODTs)

Labeling Claims: APE-free, Aflatoxin-free, Allergen-free, Aluminum-free, Antibiotics-free, Artificial Flavor-Free, BSE-free, Bisphenol A-free, Caffeine Free, Colorants-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, Ethylene Oxide-free, GMO-free, Generally Recognized As Safe (GRAS), Glycerin-free, Halal, Hormones-free, Irradiation-free, Kosher, Melamine-free, Monosodium Glutamate (MSG)-free, Nanomaterials-free, Natural Latex Rubber-Free, Non-GMO, Not Listed In California Proposition 65, Odor-free, PAH-free, PFAS-Free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Palm Oil-free, Paraben-free, Perfluorooctanoic Acid-free, Pesticide-free, Phthalates-free, Plasticizer-free, Preservative-free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, USP 232 Elemental Impurities Free, Vegan, Vegetarian

Certifications & Compliance: British Pharmacopeia (BP), China DMF, Chinese Pharmacopeia (ChP), Doping-Free, EXCiPACT, European Pharmacopeia (Ph. Eur.), European Regulation 396/2005/EC, FCC Compliant, FDA 21 CFR Regulations, FDA Compliant, FDA Food Safety Modernization Act (FSMA), Halal, ICH Q3C, Japan Pharmacopeia (JP), Kosher, Nagoya Compliant, National Formulary (NF), Regulation (EU) No. 231/2012, United States Pharmacopeia (USP)

Manufacturing Technology: Wet Granulation

Synonyms: E468, Sodium Croscarmellose

Technical Data SheetSafety Data SheetBrochure
  • TypeDocument Name
View All Documents

Enhanced TDS

Identification & Functionality

Chemical Family
Cellulose & Cellulosics
Chemical Name
Croscarmellose Sodium
Pharma & Nutraceuticals Functions
Disintegrant,
Immediate Release Agent
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Modified & Controlled Release

Features & Benefits

Labeling Claims
APE-free,
Aflatoxin-free,
Allergen-free,
Aluminum-free,
Antibiotics-free,
Artificial Flavor-Free,
BSE-free,
Bisphenol A-free,
Caffeine Free,
Colorants-free,
Dioxin-free,
Dye Free,
Endocrine Disruptor-free,
Ethylene Oxide-free,
GMO-free,
Generally Recognized As Safe (GRAS),
Glycerin-free,
Halal,
Hormones-free,
Irradiation-free,
Kosher,
Melamine-free,
Monosodium Glutamate (MSG)-free,
Nanomaterials-free,
Natural Latex Rubber-Free,
Non-GMO,
Not Listed In California Proposition 65,
Odor-free,
PAH-free,
PFAS-Free,
PFOS-free,
PHO (Partially Hydrogenated Oil)-Free,
PVC-free,
Palm Oil-free,
Paraben-free,
Perfluorooctanoic Acid-free,
Pesticide-free,
Phthalates-free,
Plasticizer-free,
Preservative-free,
Sugar-free,
TSE-free,
Tributyl Tin Compounds-Free,
Triphenyl Tin Compounds-Free,
USP 232 Elemental Impurities Free,
Vegan,
Vegetarian

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Segments
Dietary Supplement,
Pharmaceutical
Applications
Pharmaceutical — Immediate release
Dietary Supplement — Immediate release
Dosage Form
Capsules,
Granules,
Orally Disintegrating Tablets (ODTs)
Manufacturing Technology
Wet Granulation

Properties

Physical Form
Powder
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
IdentificationPass--
Sodium Chloride and Sodium Glycolatemax. 0.50%-
Degree of Substitution0.63 - 0.85--
Content of Water Soluble Material1.0 - 10.0%-
Settling Volume10.0 - 30.0mL-
pH5.5 - 7.0--
Loss on Dryingmax. 6.0%-
Heavy Metalsmax. 0.001%-
Sulfated Ash Content14.0 - 28.0%-
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Countmax. 100cfu/g-
Total Fungi (Yeast and Mold)max. 20cfu/g-
E. coliNot Detected--
Pseudomonas aeruginosaNot Detected--
Staphylococcus aureusNot Detected--
Salmonella SpeciesNot Detected--
Nutritional Information
ValueUnitsTest Method / Conditions
Moisture Contentmax. 8g/100g-
Total Energy0KJ/100g-
Total Fat0.0g/100g-
Saturated Fat0.0g/100g-
Polyunsaturated Fat0.0g/100g-
Monounsaturated Fat0.0g/100g-
Cholesterol0.0g/100g-
Sodiumapprox. 5.5g/100g-
Potassiummax. 4mg/100g-
Calcium Contentmax. 5mg/100g-
Total Carbohydrate0.0g/100g-
Dietary Fibermin. 85g/100g-
Protein0.0g/100g-
Vitamin A0.0IU/100g-
Vitamin C0.0mg/100g-
Iron Contentmax. 1mg/100g-
Note

This product meets the requirements for Residual Solvents in the United States Pharmacopeia <467> and complies with the ICH Guide Q3C for Residual Solvents.

Regulatory & Compliance

Certifications & Compliance
British Pharmacopeia (BP),
China DMF,
Chinese Pharmacopeia (ChP),
Doping-Free,
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
European Regulation 396/2005/EC,
FCC Compliant,
FDA 21 CFR Regulations,
FDA Compliant,
FDA Food Safety Modernization Act (FSMA),
Halal,
ICH Q3C,
Japan Pharmacopeia (JP),
Kosher,
Nagoya Compliant,
National Formulary (NF),
Regulation (EU) No. 231/2012,
United States Pharmacopeia (USP)
Quality Standards
ICH Q3D

Storage & Handling

Shelf Life
3 years
Shelf Life Information

Storage conditions: Store at ambient conditions. Keep containers sealed; material is very hygroscopic. Re-evaluation date: three (3) years from date of manufacture, if storage conditions stated above are observed. Re-evaluation requirements: DuPont recommends that after the above re-evaluation date, the customer perform the loss on drying test.