Your partner for high end chemical analysis

Method Development and Validation Brochure

Download our brochure and find out about our methods and what Brightlabs can do for you.

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Method Development

The development of a robust, selective, and stability indicative method for the determination of purity and or related substances is essential in the development of a new API or Drug Product.
Brightlabs has ample experience with the development of various class compounds and products, ranging from hormonal ointment to complex chiral compounds.
A method development is executed step by step, from the simple ‘proof of principle’ to a method that can be fully validated according ICH Q2 guidelines.
Secondly a forced degradation study is used to determine the stability of a drug product or drug substance, it is required to demonstrate specificity of stability indicating methods and provide insights of degradation pathways.
Download the brochure for more information about the possibilities.

About Brightlabs

Brightlabs is het laboratorium voor alle analytische vraagstukken voor de farmaceutische industrie. Het is hierbij onze missie om onze klanten te helpen bij hun farmaceutische ontwikkelingsprojecten en QC testen. Hiervoor biedt Brightlabs een breed scala aan fysische, chemische en microbiologisch analyses aan, van grondstof analyse conform farmacopee, zuiverheid van een drug-substance tot QC analyse aan drug-products. Hierbij werken we nauw samen middels co-creatie om hiermee snel en efficiënt tot een succes te komen.

Brightlabs analyses:

  • Elemental impurities
  • Residual solvents
  • Nitrosamines
  • …and many more

We have experienced Brightlabs to be a very well accessible company with experienced personnel, which is able to tackle development issues rather fast. Due to their accessibility it was easy to move these projects forward and finalize them within a very short time period (about 6 months for all projects combined). We look forward to perform new projects with Brightlabs.

Sander Pouwels, Regulatory Affairs Manager | Interdos

Since the begging we received all support Business Development and from Laboratory Team, with whom we have been working closely. Method Validation run smoothly and product analysis by GC MS/MS is now on going. With join efforts and combined forces, always reachable by e-mail or call on teams, weekly planning and product demands are managed daily to meet demanding deadlines. More than a contact Lab we now consider Bright Labs as a partner.

Mehdi Sharifi, Aurobindo

Brightlabs consist of a reliable, flexible and nice team of people with a proactive approach and good knowledge of the business. Furthermore, they deliver services of high quality and according the set timelines. It is great to work with them!

Hans van der Steen, Avivia

Download our Method Development brochure

And see what we can do for you