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Polymorphism

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

Characterization studies for your product can be conducted prior to formulation.We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Polymorphic Evaluation/Polymorph Quantification by XRD

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

Determination of physic-chemical properties as follows: Solubility with respect to temperature and pH, dissociation constant and partition coefficient, polymorphic evaluation and hygroscopicty.

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Emulsion Polymerization

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

Butyl Methacrylate emulsion polymerization that required extensive physical manipulation to achieve a narrow particle size distribution.

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Polymorph Screening

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

The comprehensive examination of the range of polymorphs which can be prepared for specific drug compounds is of profound importance for pharmaceutical companies. There are major implications in discovering all potential forms for both commercial and regulatory reasons.

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Formuldisp®

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

It is a one step process using supercritical CO2 as a solvent to incorporate an API in an excipient matrix. Process without organic solvent, it allows to obtain a complete and stable amorphization at low temperature and without mechanical stress.

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Determination of Polymorphic Form

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

Our services include the development & validation of analytical methods. We identify by-products and determine polymorphic product forms's broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, particle size determination etc.

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Polymorphism Studies

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

Following is the list of studies that can be performed at our laboratory for polymorphism: morphology, identification of polymorph, evaluation of Polymorph for Patent, euantification of Polymorph, percentage crystallinity, equilibrium solubility of the Polymorph.

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Solid Form Screening: Polymorph & Crystal Screening

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

Crystallics’ unique polymorph screening methodology enhances understanding of the polymorphic behavior of drug candidates.

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cGMP Medical Grade Polymers

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

PCI’s technical and manufacturing teams have executed countless cGMP Polymer related synthesis projects.

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