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Jump to Services NavigationSolid State Screening - Polymorph Screen
Polymorphism is defined as the occurrence of different crystalline forms of the same drug substance. This may include salvation or hydration products (also known as pseudopolymorphs) and amorphous forms.
It has been well known for many years that a change in polymorphic form of an API can have significant impact on physicochemical properties which may have serious consequences during downstream development. Properties such as solubility, dissolution rates and bioavailability can vary with different solid forms leading to an impact on safety and efficacy. It has been a regulatory requirement to investigate all new drug substances for polymorphism since the publication of the regulatory guideline ICH Q6A in 1999.
The objective of a polymorph screen is to identify new polymorphic forms, hydrates and solvates. Once identified it will be important to characterize each form and investigate the relationship between them.
Related Services
- Preformulation Package
- Solid State Screening - Salt /Co-crystal Screen
- Solid State Screening - Solid Dispersion Screen
- Solid State Screening - Super critical fluid (SCF) crystallisation screen
- Pharmaceutical and Chemical Analysis - Chromatographic Analysis
- Pharmaceutical and Chemical Analysis - Solid Form Analysis
- Pharmaceutical and Chemical Analysis - Elemental Analysis
- Pharmaceutical and Chemical Analysis - Spectroscopic and Imaging Analysis
- Pharmaceutical and Chemical Analysis - Thermal Analysis
- Pharmaceutical and Chemical Analysis - Particle Size Analysis and Surface Characterisation
