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Dissolution and Product Performance Testing

Characterize how a dosage form releases or behaves under defined conditions.

Product Characterization

Dissolution and Product Performance Testing

Dissolution and related performance tests help characterize how a dosage form releases or behaves under defined conditions. Globyz Clinical Solutions accepts projects after confirming the product, apparatus, method, medium, sampling design, analytical finish, equipment qualification, and acceptance criteria.

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Dissolution and Product Performance Testing

Dosage Form Behavior

Defined conditions & criteria

Project Types

We support a variety of testing services designed to meet specific regulatory and development requirements.

1

Compendial Testing

Compendial or approved product dissolution testing.

2

Disintegration Tests

Disintegration and selected physical performance tests.

3

Method Transfer

Method transfer or verification before routine testing.

4

Profile Comparison

Comparative profile or development support where technically feasible.

5

Stability Time Point

Stability time point dissolution testing to track product performance over its shelf life.

Technical
Review

A thorough technical review is critical to ensure that every aspect of the dissolution testing is controlled and properly executed.

The review confirms several crucial testing parameters and configurations, including:

Apparatus setup
Rotation or movement conditions
Medium preparation
Deaeration & temperature
Sampling times
Filtration methods
Replacement volume
Analytical measurement
Calculations
Sink conditions (where relevant)
System suitability

Method Suitability

A method may require transfer, verification, troubleshooting, or additional development before routine use.

Any change from the approved method is thoroughly evaluated and documented through the applicable quality process, ensuring the integrity and reliability of all analytical outcomes.

"Statistical comparison is included only when agreed and scientifically appropriate."
Data Analysis
Deliverables

Data and
Reporting

Reports present the agreed individual and summary results, method and specification references, calculations, observations, deviations, and conclusion.

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Get in touch with our experts to discuss your pharmaceutical analytical testing needs and ensure absolute compliance and quality.