Accelerate® DS - 812

1 of 2 products in this brand
Accelerate® DS - 812 contains cellulose gum and is available in capsule, granule, and orally disintegrating tablet forms. Utilizing wet granulation technology, it serves as a disintegrant in pharmaceutical and nutraceutical applications.

Chemical Name: Cellulose Gum, Croscarmellose Sodium

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

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, Hormones-free, 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, Vegan, Vegetarian

Certifications & Compliance: Doping-Free, European Regulation 396/2005/EC, FDA 21 CFR Regulations, FDA Food Safety Modernization Act (FSMA), ICH Q3C, Nagoya Compliant, Regulation (EU) No. 1272/2008, Regulation (EU) No. 231/2012, United States Pharmacopeia (USP)

Manufacturing Technology: Wet Granulation

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
IdentificationPass--
pH (at 1% dispersion)5.0 - 7.0--
Loss on Dryingmax. 6.0%-
Content of Water Soluble Materialmax. 30.0%-
Heavy Metalsmax. 0.001%-
Degree of Substitution0.65 - 0.95--
Sodium Chloride and Sodium Glycolatemax. 0.5%-
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Countmax. 1000cfu/g-
Total Fungi (Yeast and Mold)max. 100cfu/g-
Particle Size (D10)max. 25μmMalvern Ld.
Particle Size (D50)25 - 55μmMalvern Ld.
Particle Size (D90)min. 60μmMalvern Ld.
Pseudomonas aeruginosaNone Present/10g-
E. coliNone Present/10g-
Staphylococcus aureusNone Present/10g-
Salmonella SpeciesNone Present/10g-
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. 7g/100g-
Potassiummax. 4mg/100g-
Calcium Content0.0mg/100g-
Total Carbohydratemin. 85g/100g-
Dietary Fiber0.0g/100g-
Protein0.0g/100g-
Vitamin A0.0IU/100g-
Vitamin Cmax. 5mg/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

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.