Pharmaceutical Test Case

Non-Destructive Quantification of Active in Dosage Form

XRPD quantification of active ingredient crystallinity and content in finished dosage forms without destroying the sample.

Background

Solid-state properties of pharmaceuticals influence processing behavior and bioavailability. XRPD enables non-destructive quantification of crystalline API and excipients directly in finished dosage forms for production quality assurance.

Challenge

Quantify active ingredient crystallinity and content in a finished dosage form while preserving the sample and ensuring batch-to-batch consistency.

XRPD Analysis

Non-destructive quantification of API in dosage form using XRPD — XRPD pattern analysis used to quantify crystalline API and assess solid-state form.

Results

Quantification of crystalline API within the dosage form
Assessment of crystallinity and microstructural parameters
Monitoring of batch and dosage uniformity
Support for stability and process control decisions

Production QA: XRPD supports manufacturing and batch release by tracking solid-state changes that can impact solubility and bioavailability.

Related Services at DANNALAB

DANNALAB offers cGMP-compliant XRPD identity testing for pharmaceutical QC:

Small Molecule Services →

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