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ABSTRACT

Moisture determination in lyophilized pharmaceutical products is a key quality parameter because moisture directly influences product stability and performance. Karl Fischer (KF) titration is the compendial method for moisture analysis and provides total moisture content in the sample, including both bound and free water. It is a destructive technique that requires a chemical titrant and is often prone to sample-handling errors and possible interferences.

Many industries, including pharmaceuticals, are developing optical methods such as Near-Infrared analysis for indirect moisture determination of samples in sealed containers. As a secondary moisture determination method, NIR measures moisture via spectral absorption in the “cake” portion of the product and correlates it to KF values, the reference method. The key advantages of NIR include its nondestructive sampling, making the sample viable for further testing, elimination of titrants, and improved efficiency in obtaining results (2-3 minutes versus 1-2 hours)

While a universal NIR model for moisture determination would enhance the value proposition of purchasing NIR equipment for quality testing, optical differences among product chemistries, density, particle size, and vial wall thickness are among the leading performance challenges in using a Universal model.

The presentation discusses the development of a universal PLS quantitative moisture model using combined datasets from multiple pharmaceutical laboratories. The author discusses optimizing preprocessing techniques and using scores and loadings to guide PLS model development that minimizes the contributions of excipients and actives while enhancing the contributions of the free- and bound-moisture bands, providing excellent model performance.

BIOGRAPHY

Deborah Peru is the Owner and President of DP Spectroscopy & Training LLC. She has over 40 years of experience in industrial R&D and process analytical technology (PAT) in the petrochemical, specialty chemical, consumer products, and pharmaceutical industries. Her experience is focused on developing near-infrared, mid-infrared, Raman, and SERS methods for laboratory and real-time measurements. Her PAT experience includes using laboratory reactors and in situ particle-size analyzers to optimize products & processes for improved yield, stability, and performance. Ms. Peru is serving as the Secretary for both the Coblentz Society and is the Treasurer of the New York/New Jersey Regional Section of the Society for Applied Spectroscopy (SAS) and is the recipient of the 2019 SAS Distinguished Service Award

SAS Office is inviting you to a scheduled Zoom meeting.

Topic: New York / New Jersey Section of the Society for Applied Spectroscopy Invited Seminar – October 15, 2026 12:00 – 1:00 PM EDT
Time: Oct 15, 2026 11:45 AM Eastern Time (US and Canada)

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