Lactose Monohydrate: Density and Surface Area - Nova and Ultrapyc
Lactose monohydrate, found in over-the-counter medications such as acetaminophen, loratadine, and cetirizine, is often used in formulations as a filler Its structural properties were determined on the Anton Paar Nova (with 21 CFR part 11 compliance) and the Ultrapyc.
Introduction
Lactose monohydrate is used in the pharmaceutical industry primarily as a filler, adding bulk to products by binding and even stabilizing active ingredients. To prove its suitability for a formulation, researchers must determine various physical properties of the material - such as specific surface area (SSA) and skeletal density. Understanding these properties of the lactose monohydrate as a raw material is essential in guaranteeing consistency in the finished product.
A commercially-available lactose monohydrate was characterized using Anton Paar instruments, for:
- SSA using a Nova 800 BET with Kaomi for Nova 21 CFR Part 11 software
- Skeletal density using an Ultrapyc 5000
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