Ac-Di-Sol® SD - 711

1 of 2 products in this brand
Ac-Di-Sol® SD - 711 a powdered form of croscarmellose sodium, is utilized as a disintegrant and immediate release agent in pharmaceuticals and nutraceuticals. Its versatility is evident in various dosage forms, including capsules, granules, and orally disintegrating tablets (ODTs), manufactured through wet granulation techniques.

Chemical Name: Croscarmellose Sodium

CAS Number: 74811-65-7

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

Labeling Claims: APE-free, Allergen-free, Aluminum-free, Antibiotics-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, Kosher, Melamine-free, Monosodium Glutamate (MSG)-free, Nanomaterials-free, Natural Latex Rubber-Free, Non-GMO, Not Listed In California Proposition 65, 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, 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), GMP, Halal, ICH Q3C, Japan Pharmacopeia (JP), Kosher, Nagoya Compliant, National Formulary (NF), Regulation (EU) No. 1169/2011, Regulation (EU) No. 231/2012, United States Pharmacopeia (USP)

Manufacturing Technology: Wet Granulation

Synonyms: E468, Sodium Croscarmellose

Technical Data SheetSafety Data SheetBrochure
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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,
Allergen-free,
Aluminum-free,
Antibiotics-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,
Kosher,
Melamine-free,
Monosodium Glutamate (MSG)-free,
Nanomaterials-free,
Natural Latex Rubber-Free,
Non-GMO,
Not Listed In California Proposition 65,
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,
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
Product Applications
  • Immediate Release Disintegration
  • Oral Dispersible Tablets

Properties

Physical Form
Powder
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
IdentificationPass--
Sodium Chloride and N-Arachidonylglycine*max. 0.50%-
Degree of Substitution*0.63 - 0.85--
Content of Water Soluble Material*1.0 - 5.5%-
Setting Volume10.0 - 30.0mL-
pH*5.9 - 7.0--
Loss on Drying*max. 6.0%-
Sulfated Ash Content14.0 - 28.0%-
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Countmax. 100*cfu/g-
Total Fungi (Yeast and Mold)*max. 20cfu/g-
E. coliAbsent--
Pseudomonas aeruginosaAbsent--
Staphylococcus aureusAbsent--
Salmonella SpeciesAbsent--
Specifications
ValueUnitsTest Method / Conditions
Residual Solventmax. 0.01%-
Particle Size Distribution (D10)max. 25μmMalvern Ld.
Particle Size Distribution (D50)25-55μmMalvern Ld.
Particle Size Distribution (D90)min. 60μmMalvern Ld.
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metalsmax. 0.001%-
Note

*More restrictive than compendium .

Nutritional Information

Typical Nutrient Information/100g
US EU/Australia/NZ
Estimated Caloric Value 146 Cal

146 Cal/ 610 kJoules
Calories from Fat 0 Cal 0 Cal
Total Fat 0 g 0 g
Saturated Fat 0 g 0 g
Trans-Fat 0 g 0 g
Polyunsaturated Fat 0 g 0 g
Monounsaturated Fat 0 g 0 g
Cholesterol 0 mg 0 g
Sodium 7000 mg 7000 mg
Salt 0 g 17.50 g
Potassium 4 mg 4 mg
Total Carbohydrate 73 g 0 g
Sugars (Total) 0 g 0 g
Added Sugars 0 g 0 g
Starch 0 g 0 g
Total Dietary Fiber 0 g 73 g
Dietary Fiber (Soluble) 0 g 73 g
Dietary Fiber (Insoluble) 0 g 0 g
Protein 0 g 0 g
Vitamin A 0 mcg 0 mcg
Vitamin C 0 mg 0 mg
Vitamin D 0 mcg 0 mcg
Calcium 5 mg 5 mg
Iron 0 mg 0 mg
Magnesium 0 mg 0 mg
Moisture 8 g 8 g
Ash 19 g 19 g
Organic acid 0 g 0 g

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),
GMP,
Halal,
ICH Q3C,
Japan Pharmacopeia (JP),
Kosher,
Nagoya Compliant,
National Formulary (NF),
Regulation (EU) No. 1169/2011,
Regulation (EU) No. 231/2012,
United States Pharmacopeia (USP)
Chemical Inventories
AICS (Australia),
IECSC (China),
PICCS (Phillipines)

Storage & Handling

Shelf Life
3 years
Storage Conditions

Store at ambient conditions. Keep containers sealed; material is very hygroscopic.Re-evaluation requirements: IFF recommends that after the above re-evaluation date, the customer perform the loss on drying test.