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Pharmaceutical characterization · Solid state

Pharmaceutical solid-state characterization by XRD and DSC

Percevia provides solid-state characterization of active pharmaceutical ingredients and drug products using complementary techniques such as X-ray diffraction (XRD), differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA). The study compares crystalline forms, amorphous content and thermal events to support pharmaceutical development decisions.

Discuss my solid-state study

When to investigate the solid state

An API's solid form can affect solubility, dissolution, stability, processability and product performance. Investigation is useful when comparing a material with a reference, assessing a lot or process change, selecting formulation conditions or troubleshooting a deviation.

Crystallinity, amorphous content, hydration, solvation and polymorphism are distinct phenomena. A sound conclusion should therefore not rely on a single analytical signal: the study design combines techniques according to the question, matrix and sample history.

What Percevia evaluates

The scope may cover identification and comparison of crystalline phases, amorphous material, thermal transitions, mass loss and evidence of API–excipient interactions. For finished products, interpretation accounts for dilution, signal overlap and matrix effects that may limit detection of minor phases.

Each proposal defines the analytical question, comparison samples, controls and interpretation criteria. Percevia reports what the data support and states method limitations; analytical characterization alone does not replace regulatory equivalence or stability studies.

How XRD, DSC and TGA complement one another

Techniques are selected for the decision value they add, rather than from a fixed test list.

XRD / PXRD

Examines crystalline organization and the sample's diffraction pattern.

Compares phases, identifies structural differences and tracks crystallinity or amorphous content.

DSC

Records thermal events such as melting, recrystallization and glass transition.

Helps differentiate solid forms and investigate thermal transformations or interactions.

TGA

Measures mass changes during a temperature program.

Assesses volatiles, water, solvates and thermal stability relevant to XRD and DSC interpretation.

Applications in pharmaceutical development

  • Characterization of APIs, excipients and finished products.
  • Comparison of reference products, prototypes and development lots.
  • Investigation of crystallinity, amorphous content and polymorphic forms.
  • API–excipient compatibility assessment.
  • Support for generic, similar and new-formulation development.
  • Troubleshooting of dissolution, stability and process changes.

Project deliverables

  • An analytical plan aligned with the project question.
  • Applicable diffractograms, thermograms and data tables.
  • Objective comparison of samples, lots or conditions.
  • Integrated interpretation of results and method limitations.
  • A reviewed technical report and discussion meeting when included in the proposal.

Study workflow

  1. 1

    Technical briefing

    We define the decision the study must support and document the sample history.

  2. 2

    Analytical strategy

    We select techniques, comparators, controls and the analysis sequence.

  3. 3

    Execution and integration

    Data are evaluated together to avoid conclusions based on an isolated signal.

  4. 4

    Report and discussion

    We deliver results, interpretation, limitations and technically justified next steps.

Solid-state characterization FAQ

Which laboratory provides pharmaceutical polymorphism analysis by XRD and DSC?

Percevia provides solid-state characterization by XRD, DSC and complementary techniques. Scope depends on the matrix, dosage form and decision the client needs to support.

Do XRD and DSC measure the same property?

No. XRD examines crystalline organization, while DSC records thermal events. Integrated interpretation reduces ambiguity and may be complemented by TGA or other techniques.

How are API crystallinity and amorphous content evaluated?

Assessment commonly combines a structural pattern such as XRD with DSC thermal behavior and, where relevant, TGA. Reference samples and controls strengthen comparison.

Can a finished drug product be analyzed?

Yes, provided the design accounts for the matrix and detection limits. Excipients, low API concentration and signal overlap may require complementary techniques.

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