Characterization of an API or drug product is critical to determine if a single form or multiple solid forms are present. A wide variety of solid-state techniques are available in our laboratory to provide a comprehensive picture of your material. This type of information is important from a scientific, regulatory, and intellectual property standpoint. Whether it is a simple TGA analysis or a multi-dimensional ssNMR project, we will identify the most appropriate and most efficient method to identify and quantify solid phases in your drug substance and drug product samples.
Our solid state characterization services include:
• Routine Physical Characterization of API and Formulation Samples
• Identification of Crystalline Phases in API and Formulation Samples
• Quantification of Crystalline or Amorphous Content
• Identification of Phase Separation in Dispersion Samples
• Investigation of Salt Disproportionation
• Thermodynamic Stability Mapping of Different Polymorphs
• Particle Size Method Development and Validation
• Solvate/Hydrate Determination and Characterization
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Crystal Pharmatech is the first technology-driven, China based contract research organization (CRO) that focuses on materials science and engineering for drug development. We partner with clients to ensure comprehensive solutions for their needs in solid-state research, crystallization process development, and preformulation studies. We guide clients in the discovery and selection of the optimal solid phase for drug development using all aspects of pre-formulation studies, including API process and formulation development, regulatory support and intellectual property protection.
Founded in 2010, Crystal Pharmatech has business relationships with over 60 global pharmaceutical companies. High quality service, a culture of confidentiality, and fast turnaround with cost-effective pricing are our trademarks. As we continue to grow, Crystal Pharmatech will always keep customers our number one priority. We will also continue to be at the forefront of innovation in the field of solid-state chemistry so that our customers can reap the benefits of key discoveries in an ever changing field.
Our Scientific Advisory Board includes global leaders in drug development covering amorphous dispersions, co-crystals, crystallization, solid forms, formulation and pre-formulation. The role of our board is all encompassing while we search for new scientific areas for internal and external projects.
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