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, Not Tested on Animals, 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), FSSC 22000, GMP, Halal, ICH Q3C, ISO 14001, ISO 45001, ISO 9001, Japan Pharmacopeia (JP), Kosher, Nagoya Compliant, National Formulary (NF), Orthodox Union Kosher, Regulation (EU) No. 231/2012, United States Pharmacopeia (USP)

Manufacturing Technology: Wet Granulation

Synonyms: E468, Sodium Croscarmellose

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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,
Not Tested on Animals,
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),
FSSC 22000,
GMP,
Halal,
ICH Q3C,
ISO 14001,
ISO 45001,
ISO 9001,
Japan Pharmacopeia (JP),
Kosher,
Nagoya Compliant,
National Formulary (NF),
Orthodox Union Kosher,
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.