MCC SANAQ® S 101

Identification & Functionality

Chemical Name

Cellulose, Microcrystalline,

Silicon Dioxide

Pharma & Nutraceuticals Functions

Disintegrant

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Binders & Disintegrants

Features & Benefits

Product Highlights

• Co Processed mix developed to reduce some weakness of conventional binders including: low bulk density, poor flow, loss of compatibility, stickiness issues, and sensitivity to lubricants. When used for direct compression can significantly reduce the number of required excipients and formulations producing cost effective tablets.

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Capsules,

Tablets

Manufacturing Technology

Spheronization,

Wet Granulation

Applications

• Tablets, film coated tablets,Oral dispersable tablets

Properties

Physical Form

Powder,

Solid

Physico-Chemical Properties

	Value	Units	Test Method / Conditions
Residue on Ignition	1.8 - 2.2	%	USP-NF
Bulk Density	0.28-0.33	g/ml	USP-NF
Loss on Drying	max. 70	%	USP-NF
pH Value	5.0 - 7.5	—	USP-NF
Conductivity	75	μ S	USP-NF
Sulphate Ash /Residue on Ignition	0.1	%	USP-NF
Water Soluble Substances	0.25	%	USP-NF
Ether Soluble Substances	0.05	%	USP-NF

Microbiological Values

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

Composition

	Value	Units	Test Method / Conditions
Heavy Metals	max. 10	𝜇/g	USP-NF

Regulatory & Compliance

Certifications & Compliance

European Pharmacopeia (Ph. Eur.),

Japan Pharmacopeia (JP),

National Formulary (NF),

United States Pharmacopeia (USP)

Grade

Pharma Grade