Quantitative Analysis

Quantify particles, pores, and coatings from images. Designed for pharmaceutical scientists with QbD and regulatory needs.

4K microstructure render of a DigiM pharmaceutical sample showing internal phase composition at high resolution
Full field-of-view pharmaceutical tablet microstructure image showing internal phase distribution and pore network
Quantitative Analysis

Image to Insight

Every pixel holds valuable information. I2S extracts critical structural information from 2D and 3D images, transforming them into actionable data. Utilizing grayscale image data, segmentations and morphological features I2S users can extract numerous numerical statistics from there images, such as:

  • Volume Fractions
  • Surface Area
  • Size Distribution
  • Spatial Distribution
  • Thickness
  • and more...
Color-coded segmentation of a Trazodone pharmaceutical particle showing distinct material phases identified by digiM I2S
Quantitative Analysis

Pharma Critical Quality Attributes (CQAs)

While generally applicable, I2S analysis-suites are specifically tailored for pharmaceutical applications with complex and highly demanding scientific, medical safety, and regulatory requirements.  digiM I2S goes beyond “CAN DO” – what can be computed, into “SHOULD DO” – what should be computed as the most critical, discrimitaroy, and quality and performance relevant attributes, from dissolution controlling  porosity in tablets, stability controlling coating thickness on pellets, or release rate controlling polymer network in implants.


More information on the figure can be found here.

3x3 grid displaying multiple segmentation analysis views of pharmaceutical sample with different visualization modes
Upscaled FIB-SEM image 4 of a pharmaceutical sample showing cross-sectional material phases at nanoscale resolution
Quantitative Analysis

Chart Studio: Quantify, Compare, Improve.

I2S data management and Chart Studio tool enables easy correlations and comparison across different images, samples, and formulations. Connecting microstructural measurements with process parameters, formulation and performance metrics enables new levels of optimization and increased insights. Built with digiM's rich expertise in the industry, the I2S platform helps to reveal those connections and correlations, empowering users to make data-driven decisions. Users can generate, customize, and export publication quality charts without leaving I2S ecosystem.

Density distribution graph showing quantitative measurement results from pharmaceutical microstructure analysis
Quantitative Analysis

Regulatory Ready

I2S analysis and quantification results are validated, demonstrated with discriminatory powder, and tested with repeatability. With full audit trail traceability from input image to final metric, I2S analysis is built to support regulatory filing, including FDA’s regulatory science research.

SEM cross-section image of a microsphere showing internal structure and surface morphology
Upscaled FIB-SEM image 4 of a pharmaceutical sample showing cross-sectional material phases at nanoscale resolution

Transform Your Program with Microstructure Science

Get started with a drug product digital twin.

Purple tablet dispersing into a fine particle cloud, illustrating drug microstructure disintegration
Upscaled FIB-SEM image 4 of a pharmaceutical sample showing cross-sectional material phases at nanoscale resolution
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AbbVie logo
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Bausch Health logo
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Bristol Myers Squibb logo
Bristol Myers Squibb logo
Merck logo
Merck logo
Moderna logo
Moderna logo
Novartis logo
Novartis logo
Pfizer logo
Pfizer logo
Johnson & Johnson Innovative Medicine logo
Johnson & Johnson Innovative Medicine logo
Roche logo
Roche logo
Mirati Therapeutics logo
Mirati Therapeutics logo
Genentech logo
Genentech logo
Lonza logo
Lonza logo