Why study API polymorphism?
APIs, or active pharmaceutical ingredients, are the substances contained in medicines that produce beneficial effects for the patient’s health. Polymorphism analysis of APIs makes it possible to confirm polymorphic stability over time, which is essential when developing a medicine for the market.
The laboratory studies the polymorphism of your apis in medicines
FILAB provides pharmaceutical manufacturers with technical expertise and a state-of-the-art analytical platform to respond to their requests as effectively and promptly as possible, offering the most appropriate services and tailored support.
FILAB provides tailored support for the polymorphism analysis of your APIs:
- Analysis of active pharmaceutical ingredients (APIs) by XRD and DSC – X-ray diffraction (XRD) for the identification of crystalline phases – DSC analysis to determine melting and crystallization temperatures.
- API compatibility and stability studies
- Development of analytical methods for API assay in accordance with current standards
The filab advantages
A highly qualified team
Responsiveness in responding to and processing requests
A COFRAC ISO 17025 accredited laboratory
(Staves available on www.cofrac.com - Accreditation number: 1-1793)
A complete analytical facility of 5,200m²
Tailor-made support
Video debriefing available with the expert
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