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, 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, 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, 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), Generally Recognized As Safe (GRAS), Halal, ICH Q3C, IFRA Compliant, 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.