MCC SANAQ® 102

Identification & Functionality

Chemical Name

Cellulose, Microcrystalline

Pharma & Nutraceuticals Functions

Anti-Caking Agent,

Binder,

Bulking Agent,

Diluent,

Filler,

Stabilizer,

Texturizing Agent,

Thickener,

Viscosity Modifier

CAS No.

9004-34-6

EC No.

232-674-9

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Binders & Disintegrants,

Carriers & Bulking Agents,

Emulsifiers & Stabilizers,

Fillers & Diluents,

Formulation & Processing Aids,

Other Excipients

Features & Benefits

Product Highlights

• MCC SANAQ® is pure microcrystalline cellulose, which chemical and physical identities meet the international standards (Pharm Eur., USP/NF, JP, Kosher).
• MCC SANAQ® has excellent compressibility. The outstanding plasticity enables to produce tablets with high temper and ultimate strength. At the same time the tablets have very short disintegration times. Its good flowing properties guarantee high production rates. High microbial purity, color stability and excellent absorption properties of MCC SANAQ® lead to success in all tableting processes.
• MCC SANAQ® is a nonreactive substance with homogenous particle size. This makes it ideal as filter Material in separation technology to guarantee results of high quality.

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Capsules,

Tablets

Manufacturing Technology

Direct Compression,

Wet Granulation

Applications

• MCC SANAQ® is mainly used as filling, binding and blasting material for tableting (direct tableting), as well as for dry and wet granulation and as filling material for hard gelatine capsules.
• MCC SANAQ® fine grade types have an enormous swelling power to be used as stabilizers for suspensions.
• MCC SANAQ® is used as filter material in separation technology.
• MCC SANAQ® is suitable for cosmetics, as stabilizer for emulsions, as absorption and turbidity material and as viscosity regulator.

Properties

Physical Form

Powder,

Solid

Odor

odourless

Appearance

White to almost white, fine or granular powder

Physico-Chemical Properties

	Value	Units	Test Method / Conditions
Residue on Ignition	1.8 - 2.2	—	USP-NF
Bulk Density	0.28 - 0.37	g/cm3	USP-NF
Loss on Drying	max. 70	%	USP-NF/Ph. Eur.
pH Value	5.0 - 7.5	—	USP-NF
Conductivity	75	μ S	USP-NF
Sulphate Ash /Residue on Ignition	0.1	%	USP-NF/Ph. Eur.
Water Soluble Substances	0.25	%	USP-NF/Ph. Eur.
Ether Soluble Substances	0.05	%	USP-NF/Ph. Eur.

Microbiological Values

	Value	Units	Test Method / Conditions
Total Aerobic Count	max. 1000	CFU/g	USP-NF / Ph. Eur.
Moulds and Yeasts	max. 100	CFU/g	USP-NF / Ph. Eur.
E. Coli, Pseudomonas Aeruginosa	Negative in 10 g sample	—	USP-NF / Ph. Eur.
St. Aureus, Salmonella Species	Negative in 10 g sample	—	USP-NF / Ph. Eur.

Particle Size Distribution

	Value	Units	Test Method / Conditions
Particle Size	60 - 100	μm	Malvem Method

Regulatory & Compliance

Certifications & Compliance

European Pharmacopeia (Ph. Eur.),

National Formulary (NF),

United States Pharmacopeia (USP)

Chemical Inventories

EINECS (EU)

Grade

Pharma Grade