Avicel® PH - 112

1 of 18 products in this brand

Avicel® PH - 112 is used in direct compression, dry granulation, and wet granulation applications. It is caffeine-free, CMR substance-free, diethylene glycol-free, and dioxane-free, ensuring safe and effective pharmaceutical formulations.

Chemical Name: Cellulose, Microcrystalline

CAS Number: 9004-34-6

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

Labeling Claims: BSE-free, Generally Recognized As Safe (GRAS), Halal, Kosher, TSE-free, Vegan, Vegetarian

Certifications & Compliance: EXCiPACT, European Pharmacopeia (Ph. Eur.), FSSC 22000, Generally Recognized As Safe (GRAS), Halal, ISO 9001, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), cGMP

Manufacturing Technology: Direct Compression, Dry Granulation, Wet Granulation

Synonyms: Crystalline cellulose, Micro Fibril Cellulose, Pyrocellulose

Technical Data Sheet Safety Data Sheet Brochure

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Enhanced TDS

Identification & Functionality

Chemical Family: Cellulose & Cellulosics
Chemical Name: Cellulose, Microcrystalline
Pharma & Nutraceuticals Functions: Binder,
Compression Aid,
Filler,
Immediate Release Agent
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Fillers & Diluents,
Formulation & Processing Aids,
Modified & Controlled Release,
Other Excipients

Features & Benefits

Labeling Claims: BSE-free,
Generally Recognized As Safe (GRAS),
Halal,
Kosher,
TSE-free,
Vegan,
Vegetarian

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Segments: Pharmaceutical
Applications: Pharmaceutical — Controlled release
Pharmaceutical — Immediate release
Dosage Form: Capsules,
Effervescent Tablets,
Granules,
Orally Disintegrating Tablets (ODTs),
Pellets,
Tablets
Manufacturing Technology: Direct Compression,
Dry Granulation,
Wet Granulation
Application: Tablet Binding

Properties

Physical Form

Soluble in

Copper Tetrammine Hydroxide

Physico-Chemical Properties


	Value	Units	Test Method / Conditions
Loss on Drying	max. 1.5	%	-
Bulk Density	0.28 - 0.34	g/cc	-
Identification (A,B)	Passes	-	-
Degree of Polymerization (Identification C)	max. 350	units	-
pH	5.5 - 7.0	-	-
Conductivity	max. 75	μS/cm	-
Residue on Ignition	max. 0.05	%	-
Water Soluble Substances	max. 12.5	mg/5g	-
Water Soluble Substances	max. 0.25	%	-
Ether Soluble Substances	max. 5.0	mg/10g	-

Microbiological Values


	Value	Units	Test Method / Conditions
Total Aerobic Microbial Count	max. 100	cfu/g	-
Total Yeast and Mold Count	max. 20	cfu/g	-
Pseudomonas aeruginosa	Absent	10g	-
E. coli	Absent	10g	-
Staphylococcus aureus	Absent	10g	-
Salmonella	Absent	/10g	-
Coliform	Absent	10g	-

Specifications


	Value	Units	Test Method / Conditions
Particle Size Distribution (D10)	14 - 50	-	-
Particle Size Distribution (D50)	70 - 150	-	-
Particle Size Distribution (D90)	160 - 295	-	-
Particle Size (Air Jet, + 60 mesh (250 microns))	max. 8	wt.%	-
Particle Size (Air Jet, + 200 mesh (75 microns))	min. 45	wt.%	-

Heavy Metals


	Value	Units	Test Method / Conditions
Heavy Metals	max. 0.001	%	-

Note

*More restrictive than compendium

Regulatory & Compliance

Certifications & Compliance: EXCiPACT,
European Pharmacopeia (Ph. Eur.),
FSSC 22000,
Generally Recognized As Safe (GRAS),
Halal,
ISO 9001,
Japan Pharmacopeia (JP),
Kosher,
National Formulary (NF),
cGMP
Quality Standards: EN ISO 9001:2015,
ISO 22000

Storage & Handling

Shelf Life: 4 years
Storage Conditions: Store at ambient conditions. Keep containers sealed; material is very hygroscopic.IFF recommends that after the above re- evaluation date, the customer perform the loss on drying test.