What are the differences between grades of Avicel PH?
Answer: With the exception of Avicel PH-300 grades, these products differ by moisture content or particle size. The Avicel PH-300 series is manufactured from a different pulp source, which provides a higher bulk density.
What is the shelf life of Avicel PH grades?
Answer: Due to its chemical nature, these products do not have true expiration dates. Rather, a recertification of loss on drying after four years from date of manufacture is recommended.
What happens when low moisture grades of Avicel are exposed to moisture?
Answer: In the original container, Avicel PH-112 will remain in its basic, low moisture state, however, if it is exposed to higher levels of moisture it will pick up moisture and essentially convert to Avicel PH-102. It will go to a moisture level of about 8.5% after a few hours at 75%RH at RT. At 43% RH at RT it will equilibrate at about 5.5%. This is generally not a problem during the normal course of production as long as the granulation is stored in tight containers and protected from humidity following compaction.
How does Avicel function as a tablet binder?
Answer: An extremely desirable characteristic of Avicel product is compressibility under pressure. Under compaction, Avicel PH undergoes a plastic deformation process that facilitates hydrogen bonding between the adjacent cellulose particles.
How are Avicel PH products packaged?
Answer: A number of different package alternatives are available ranging from 20 to 500 kilograms.
What is the melting temperature of Avicel PH?
Answer: Avicel does not have a melting point temperature. It chars at temperatures around 400°C, regardless of grade.
What is the regulatory status of Avicel PH grades?
Answer: These products are tri-compendial meeting requirements in the JP, Ph. Eur., and USP/NF.
What are the recommended storage conditions for Avicel PH grades?
Answer: We recommend these products be stored in ambient conditions (approximately 25C) and protected from moisture. These are, however, extremely stable and inert products.
How is a long-term and reliable supply of these strategic excipients assured?
Answer: We have a robust risk management program on three levels: 1) raw material sourcing; 2) dual production facilities; and 3) capacity management.
Are “Quality by Design” (QbD) registrations available?
Answer: Yes. We offer a range of services including process data, special samples, and technical service to accommodate customer’s pharmaceutical design space.
Are samples available?
Answer: Yes, we provide free samples to qualifying universities and corporations in ½ or 2 kilogram sizes.
What is the regulatory status on MCC and mannitol - a new co-processed excipient?
Answer: Avicel HFE is a physical combinatioin of never-dried microcrystalline cellulose co-spray dried with mannitol. The MCC and mannitol used are produced to meet the standards set forth in the United States Pharmacopeia/National Formulary, The European Pharmacopoeia and the Japanese Pharmacopoeia. The MCC and mannitol used are produced to meet the appropriate regulations of The US, EU, and Japan as applicable to its use in dietary supplements.
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