Avicel CE-15.QXD - FMC BioPolymer

FMC CorporationFMC BioPolymerUnited StatesPhiladelphia, PennsylvaniaEuropeBrussels, BelgiumAsia-PacificHong KongLatin AmericaMontevideo, UruguayMiddle EastAmman, JordanSales/Technical Assistance:Tel: 1 215 299 6534Fax: 1 215 299 6669Customer Service:Tel: 1 800 526 3649Fax: 1 215 299 6475Sales/Technical Assistance:Tel: +32 2 775 8311Fax: +32 2 775 8300Customer Service:Tel: +353 21 4354 133Fax: +353 21 4353 057Tel: +852 2839 6600Fax: +852 2576 3770Tokyo, JapanTel: +81 3 3402 3739Fax: +81 3 3402 3700Tel/Fax: +5982 6043030Tel/Fax: +5982 6043104Tel: +962 6 4618150Fax: +962 6 4618156www.fmcbiopolymer.compharm_info@fmc.comPatentsFMC Corporation does not warrant against infringement of patents of third parties byreason of any uses made of the product in combination with other material or in theoperation of any process, and purchasers assume all risks of patent infringement byreason of any such use, combination or operation.The products, processes and uses thereof described herein are covered by one ormore patent applications or patents.WarrantyBecause of the numerous factors affecting results, FMC ingredients are sold on theunderstanding that purchasers will conduct their own tests to determine the suitabilityof these products for their particular purpose. The several uses suggested by FMCCorporation are presented only to assist our customers in exploring possible applications.All information and data presented are believed to be accurate and reliable, butare presented without the assumption of any liability by FMC Corporation.Technical ServiceThe information contained in this bulletin is intended to be general in nature.Techniques and data pertaining to specific uses for FMC ingredients and newdevelopments will be published periodically in the form of supplemental applicationbulletins. Our technical staff is ready to offer assistance in the use of Avicel CE-15.Regulatory StatusIn the United States, microcrystalline cellulose co-processed with guar gum isGenerally Recognized As Safe (GRAS) when used as a tableting aid in dietarysupplements at a level no greater than 10%. FMC maintains a Type IV Drug MasterFile (Excipients) for Avicel CE-15 at the US Food and Drug Administration to supportits use in drugs. The guar gum used to produce Avicel CE-15 is NF grade. Thisproduct is produced in compliance with the appropriate requirements for BulkPharmaceutical Excipient Good Manufacturing Practices as developed by IPEC-America (and also published in the USP as General Chapter ).FMC, Avicel and Not Just Products. Partners. - FMC trademarks.©1995 FMC Corporation. All rights reserved.10/95CE-15 (2/99)