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Spray Dried Lactose Monohydrate, NF, Ph. Eur., JP,
BP
(Note: Identical to FMC Corporation's SuperTab Lactose product.)
Description of Lactose Powder:
This lactose powder is specifically engineered for pharmaceutical direct compression tableting and is particularly well-suited in high dose formulations of poorly compressible actives. It is a free-flowing, white, spray-dried powder consisting of spherical particles. Each sphere is composed of minute lactose alpha-monohydrate crystals bonded with amorphous lactose. Additionally, the feedstock of this lactose powder is sourced from one of the world's uniquely pollution-free rural environments, and is remarkably pure even before processing. Benefits: ·Excellent flow characteristics ·Improved tablet weight uniformity ·Exceptional carrying capacity ·Rapid tablet disintegration ·Excellent compressibility ·Low hygroscopicity ·Low reactivity with active ingredients ·Excellent physical, chemical and microbiological stability ·Solubility aids in drug dissolution Note: This lactose powder
is manufactured in New Zealand by The Lactose Company of New Zealand, Ltd.
Regulatory Status of this Lactose Powder:
This spray -dried lactose monohydrate meets the standards set forth in the United States Parmacopeia/National Formulary, European Pharmacopoeia, Japanese Pharmacopoeia and the Food Chemicals Codex. It is manufactured in accordance with current Good Manufacturing Practice, and is in compliance with the Federal Food, Drug and Cosmetic Act, as amended, and applicable regulations. |