Avicel® PH - 200 composed of microcrystalline cellulose, finds application in tablet formulations. Manufactured using direct compression, dry granulation, and wet granulation techniques, it serves as a binder and compression aid. Derived from non-animal sources, it meets pharmaceutical and nutraceutical standards.

Chemical Name: Cellulose, Microcrystalline

CAS Number: 9004-34-6

Dosage Form: Tablets

Labeling Claims: APE-free, Allergen-free, Aluminum-free, Amine-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, Heavy Metal-free, Hormones-free, Impurities-free, Kosher, Latex-free, Monosodium Glutamate (MSG)-free, Natural Latex Rubber-Free, Nitrosamines-free, Non-GMO, 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), Doping-Free, EU Cosmetic Regulation 1223/2009 Compliant, EXCiPACT, European Pharmacopeia (Ph. Eur.), European Regulation 396/2005/EC, FDA Compliant, FDA Food Safety Modernization Act (FSMA), FSSC 22000, Generally Recognized As Safe (GRAS), Halal, Hazard Analysis Critical Control Point (HACCP), ICH Q3C, IFRA Compliant, ISO 22000, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), Regulation (EU) No. 1272/2008, Regulation (EU) No. 231/2012, United States Pharmacopeia (USP), cGMP

Manufacturing Technology: Direct Compression, Dry Granulation, Wet Granulation

Synonyms: Crystalline cellulose, Micro Fibril Cellulose, Pyrocellulose

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble in
Copper Tetrammine Hydroxide
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Drying (More restrictive than compendium)2.0 - 5.0%-
Bulk Density0.29 - 0.36g/cc-
Identification (A,B)Pass--
Degree of Polymerizationmax. 350units-
pH (More restrictive than compendium)5.5 - 7.0--
Conductivitymax. 75μS/cm-
Residue on Ignitionmax. 0.05%-
Water Soluble Substancesmax. 12.5mg/5g-
Water Soluble Substancesmax. 0.25%-
Ether Soluble Substancesmax. 5.0mg/10g-
Heavy Metalsmax. 0.001%-
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Count (More restrictive than compendium)max. 100cfu/g-
Yeast and Mold Count (Total, More restrictive than compendium)max. 20cfu/g-
Pseudomonas aeruginosaAbsent/10g-
E. coliAbsent/10g-
Staphylococcus aureusAbsent/10g-
Salmonella SpeciesAbsent/10g-
Coliform SpeciesAbsent/10g-
Particle Size Distribution
ValueUnitsTest Method / Conditions
Particle Size (D10)0 - 175--
Particle Size (D50)142 - 280--
Particle Size (Air Jet, 60 mesh, 250 microns)min. 10wt%-
Particle Size (Air Jet, 100 mesh, 150 microns)min. 50wt%-

Regulatory & Compliance

Technical Details & Test Data

Typical Nutrient Information/100g
  US EU/Australia/NZ
Estimated Caloric Value 0 Cal

194 Cal/ 811 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 mg
Sodium 5 mg 5 mg
Salt -g 0.01 g
Potassium 0 mg 0 mg
Total Carbohydrate 97 g 0 g
Sugars (Total) 0 g 0 g
Added Sugars 0 g 0 g
Starch 0 g 0 g
Total Dietary Fiber 97 g 97 g
Dietary Fiber (Soluble) 0 g 0 g
Dietary Fiber (Insoluble) 97 g 97 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 1 mg 1 mg
Iron 0.2 mg 0.2 mg
Magnesium 0 mg 0 mg
Moisture 3 g 3 g
Ash 0 g 0 g
Organic acid 0 g 0 g

US: Calories = [(Total Carbs + Protein) * 4 Cal/g + (Fat * 9 Cal/g)]. Soluble fiber is included in Total Carbs, but calorie contribution is calculated at 2 Cal/g. In the US, food manufacturers have the option to exclude the amount of insoluble fiber from the calorie calculation.
EU: Calories = ([Carbs (sugars + starch ) + Protein] * 4 Cal/g) + (Fat * 9 Cal/g) + (All dietary fiber * 2 Cal/g) + (Organic acids * 3 Cal/g)). In Europe, fiber is listed separately and is not included in the carb content. Other calorie conversion factors exist, none of which is relevant to this product.

Storage & Handling

Shelf Life
4 years
Shelf Life Information

Store at ambient conditions. Keep containers sealed; material is very hygroscopic. Four (4) years from date of manufacture, if storage conditions stated above are observed. IFF recommends that after the above re-evaluation date, the customer perform the loss on drying test. Typical Degree Polymerization range for Avicel PH microcrystalline cellulose is 100 to 300.