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MICROCEL® MC-102 Microcrystalline Cellulose - Pharma

MICROCEL® Microcrystalline cellulose is used in pharmaceutical and nutraceutical applications as a filler/binder and fiber source in various oral dosage forms. Applications Swallowable tablets Hard capsules Blends Granules Pellets premix Features Available in a large range to meet different formulation, process and dosage form requirements Large surface area allows adsorption of particles or liquids and a certain capacity to act as a disintegrant Spray dried and offered from EXCiPACT (International Pharmaceutical Excipients Certification) certified plant

Brand: MICROCEL (3 products)

Chemical Name: Cellulose, Microcrystalline

CAS Number: 9004-34-6

Dosage Form: Capsules, Granules, Orally Disintegrating Tablets (ODTs), Pellets, Powder & Powder Blends, Sachets, Stick, Tablets

Labeling Claims: BSE-free, Halal, Kosher, Pesticide-free, TSE-free, Vegan

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), FDA IID, Halal, ISO 9001, Japan Pharmacopeia (JP), Kosher, United States Pharmacopeia (USP)

Manufacturing Technology: Direct Compression

Synonyms: Crystalline cellulose, Micro Fibril Cellulose, Pyrocellulose

Technical Data Sheet Safety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name: Cellulose, Microcrystalline
Pharma & Nutraceuticals Functions: Binder,
Disintegrant,
Filler
CAS No.: 9004-34-6
EC No.: 232-674-9
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Fillers & Diluents

Features & Benefits

Labeling Claims: BSE-free,
Halal,
Kosher,
Pesticide-free,
TSE-free,
Vegan

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Dosage Form: Capsules,
Granules,
Orally Disintegrating Tablets (ODTs),
Pellets,
Powder & Powder Blends,
Sachets,
Stick,
Tablets
Manufacturing Technology: Direct Compression

Properties

Physical Form

Odor

Odorless

Appearance

White non fibrous powder

Physico-Chemical Properties


	Value	Units	Test Method / Conditions
Bulk Density	0.28 - 0.33	g/cm³	-
Conductivity	max. 75	μS/cm	-
Ether Soluble Substances	max. 0.05	%	-
Loss on Drying	max. 7.0	%	-
pH	5.0 - 7.0	-	-
Residue on Ignition	max. 0.05	%	-
Retained on 200 Mesh (75 micron)	min. 45.0	%	-
Retained on 60 Mesh (250 micron)	max. 8.0	%	-
Water Soluble Substances	max. 0.24	%	-

Microbiological Values


	Value	Units	Test Method / Conditions
Escherichia coli	Absent	per gram	Plate count
Pseudomonas aeruginosa	Absent	per gram	-
Salmonella	Absent	per 10g	-
Staphylococcus aureus	Absent	per gram	-
Total Aerobic Microbial Count	max. 1000	CFU/g	Plate count
Total Yeasts and Moulds Count	max. 100	CFU/g	-

Regulatory & Compliance

Certifications & Compliance: European Pharmacopeia (Ph. Eur.),
FDA IID,
Halal,
ISO 9001,
Japan Pharmacopeia (JP),
Kosher,
United States Pharmacopeia (USP)
Chemical Inventories: AICS (Australia),
ENCS (Japan),
IECSC (China),
INSQ (Mexico),
ISHL (Japan),
KECI (Korea),
NZIoC (New Zealand),
PICCS (Phillipines),
TCSI (Taiwan),
TSCA (USA)
Grade: Pharma Grade
Quality Standards: ICH Q7
Conformity: Complies with the current USP/NF/EP requirements.

Technical Details & Test Data

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Packaging & Availability

Packaging Information

ROQ Product Code: 105107
Article (SKU) Code: 105107551
Package Size & Type: 15 kg bag

Storage & Handling

Shelf Life: 3 Years
Storage and Handling: Store in dry area, in tight containers.