Particle Size Challenge
Particle properties such as particle size and morphology are usually critical quality attributes of APIs and final pharmaceutical forms, because they can be crucial to define the:
Pharmacological properties of drugs
Processability of APIs during manufacturing
Quality of both API-raw material and final form
When a particle property such as Particle Size Distribution (PSD) need to be characterized, several questions and challenges can arise:
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Which is the best technique to analyse PSD?
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How do we assess and define the best sample preparation and measurement parameters in a method to analyze PSD?
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Is it possible to optimize and validate a particle size analysis method?
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Is it possible to characterize both original (agglomerated, granulated) and primary particles of an API, and even quantify the percentage of agglomerates presents in a sample?
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Is it possible to determine PSD of an API once formulated in its final pharmaceutical form?
Our Proposal
On the base of deep knowledge and understanding on particle size and shape analysis by “Laser Diffraction” and “Optical Microscopy with Image Analysis”, we offer the combination of both techniques to give answer to any particle characterization need. We develop this strategy supported by a vast experience to characterize any kind of material such as APIs (raw materials), product intermediates and final formulations.
our developed
solution
Here we list some of the solutions we successfully offer to our customers:
- Combined use of Laser Diffraction and Image Analysis in Optical Microscopy to give evidence of particle evolution while changing measurement parameters (sonication in wet mode, air pressure in dry mode, type of dispersant, measurement time...).
- Confirmation of PSD Laser Diffraction method accuracy by Optical Microscopy.
- Method development, validation and implementation customized not only to API chemical nature but also to any solid state nature (crystals/agglomerates/micronized particles) or final formulation (emulsion, suspension, powder, gel, tablet).
Benefits obtained
Nanomol Technologies cGMP contract analysis is able to:
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Fully adapt to customer requirements.
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Analyse all kind of particles from APIs, and also particles from intermediate products and final pharmaceutical forms.
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Analyse particles from any product coming from food, cosmetic, chemical and construction sectors. The GMP quality system ensures our services are provided with the highest quality.
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