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Stability studies

Stability studies form the foundation for a reliable shelf life.

Stability studies answer a question required by every regulatory dossier: how does your product behave over time?

Shelf life is not an assumption; it is a measurement.

A claimed shelf life must be supported by data, not expectations. Stability studies track your product over time and under controlled conditions, so you can state with certainty when a product no longer meets specifications.

Stability studies are therefore relevant in every sector we serve.

Stability testing is a matter of time, not haste.

A reliable stability study requires patience, consistent analytical methods over a long period, and the discipline to handle every time point in exactly the same way.

Long-term consistency

A study can last for months or years. The method and conditions must remain exactly the same throughout that entire period to ensure comparable results.

Conditions that reflect real-world practice

Temperature, humidity, and light exposure must reflect actual storage and transport conditions, not just the ideal laboratory environment.

Early signs of degradation

Subtle changes early on can point to larger problems later. We identify degradation patterns before they exceed specifications.

Expertise

Reliability

Flexibility

Partnership

From study design to shelf-life claim.

Every stability study at Brightlabs follows a structured approach, tailored to the requirements of ICH guidelines and your specific product.

Drafting the study protocol

We determine which parameters must be measured, under what conditions, and at which time points, aligned with ICH Q1A(R2) and your regulatory context.

Storing samples under controlled conditions

Samples are stored at defined temperature and humidity conditions, with full monitoring and documentation of the storage environment.

Analysis at fixed time points

At every predetermined time point, we analyze the samples using the same validated method to ensure that results are mutually comparable.

Analyzing trends and degradation

We monitor the development of critical parameters over time and identify trends that may indicate a decrease in shelf life.

Substantiating shelf life

Based on the collected data, we substantiate a shelf life that you can use in your regulatory dossier.

Sectoren waar methodeontwikkeling essentieel is.

Farma

Nieuwe verbindingen, complexe formuleringen, generieke geneesmiddelen

Cannabis

Plantaardige matrices, innovatieve CBD-producten, niet-standaard extracten

Voeding

Innovatieve ingrediënten, bijproducten, niet-standaard matrices

Industry

Klantspecifieke verbindingen en industriële materialenerialen

Verder verkennen.

Nitrosamine analysis

Brightlabs develops advanced analytical methods for the detection of nitrosamines and API-specific nitrosamine impurities (NDSRIs), enabling pharmaceutical organizations to comply with stringent regulations.

Impurity Analysis

Impurities often determine the difference between an approved and a rejected product. We bring them into focus.

QC Testing

QC testing is not a formality. It is the final, decisive check before a product reaches the market.

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Brightlabs appoints COO

Today, we are pleased to announce the strengthening of our team with the appointment of Dr. Sander Kok as Chief Operating Officer.

Put the soil to work for resilient crops

Brightlabs and Soil Vision have jointly developed a smart analysis method that reveals how soil life functions and how you can optimize it.

The complete overview of what Brightlabs does.

Download our brochure for a complete overview of our analytical capabilities, services, and scientific approach.