SUGAR SPHERES SANAQ 300 - 400 - PHARMATRANS SANAQ AG

Identification & Functionality

Chemical Name: Sugar Spheres
Pharma & Nutraceuticals Functions: Carrier,
Coating System,
Filler
CAS No.: 92004-84-7
EC No.: 618-806-1
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Carriers & Bulking Agents,
Fillers & Diluents,
Pharmaceutical Coatings

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Dosage Form: Capsules,
Sachets,
Tablets
Manufacturing Technology: Tablet Coating
Applications: The Sugar Spheres SANAQ® are designed for the production of dry dosage forms, especially for formulations with a controlled release of the active substance (sustained release).

With its use muliparticular systems are achieved, which can be filled in capsules, sachets or tablets. The neutral starter cores can be used with the different technologies for layering and coating.

Such technology is used in the pharmaceutical industry but also with neutraceuticals / food supplements and in the food industry.

Properties

	Value	Units	Test Method / Conditions
Friability	max. 5.0	%	Ph. EUR / USP
Loss on Drying	max. 4.0	%	Ph. EUR / USP
Sulphate Ash /residue on Ignition	max. 0.2	%	Ph. EUR / USP

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

	Value	Units	Test Method / Conditions
Sucrose Content	max. 62.5 - 91.5	%	Ph. EUR / USP
Heavy Metals	5	ppm	Ph. EUR / USP

Regulatory & Compliance

Certifications & Compliance: European Pharmacopeia (Ph. Eur.),
National Formulary (NF),
United States Pharmacopeia (USP)
Chemical Inventories: EINECS (EU)
Grade: Pharma Grade

SUGAR SPHERES SANAQ® 300 - 400