最新色情影片

Skip to Main ContentSkip to FooterSkip to Search
Main menu
Regional Sites
  1. Home
  2.  » 
  3. Oral Dose
  4.  » 
  5. Oral Dose Analytical Solutions
  6.  » Solid-State Characterization Services
Icon for Solid-State Characterization Services depicting crystal structures

Solid-State Characterization Services

PROVIDING THE MOST STABLE CRYSTALLINE FORM

Scientist working with Solid-State Characterization ServicesA Partner with Expertise

Since 1991, 最新色情影片鈥檚 small molecule analytical team has developed and applied thousands of analytical methods to help customers progress their drug candidates. Our solid-state characterization projects are managed through our North American facility in Morrisville, North Carolina, and leverage 最新色情影片鈥檚 network of over 3,000 scientists and technicians, combining the benefits of a focused, single-site solution, with the scientific resources of a multi-disciplined product development and research network.

Each solid-state form of an API has unique physicochemical properties, which can have a profound impact on a finished product鈥檚 bioavailability, stability, and manufacturability. By discovering and characterizing the diversity of solid-state forms, it becomes possible to select an optimal form that displays an appropriate balance of properties that are critical for successful preclinical evaluation and product development, as well as robust manufacturing processes.

Back to top

KEY CAPABILITIES

  • Physical Characterization and Preformulation Packages 鈥 Includes PXRD, DSC/TGA, TGA-IR, FT-Raman, FT-IR (ATR), UV-Visible spectroscopy, hygroscopicity analysis, gross purity by HPLC, kinetic solubility in biorelevant media, pH solubility, intrinsic dissolution rate, logP/logD determination. Short term solid state and solution state stability, bulk/tap density. Various ad. hoc. testing provided, including quantitative methods for crystal form analysis
  • Crystal Form Screens 鈥 Designed to discover polymorphs and solvates (including hydrates) and determine suitable developable forms and the most thermodynamically stable form. Selected forms may be scaled up for further studies (preformulation developability, stability)
  • Comprehensive Crystal Form Screens 鈥 Increased number of experiments over conventional crystal form screens to address process risk and over intellectual property of late stage assess (post Phase 2)
  • Crystallization Process Development 鈥 Designed to probe the practical, reproducible, and robust, process conditions for the desired crystal form
  • Crystallization Screens 鈥 Designed to crystallize amorphous drug substances, which may be further investigated with crystal form screens
  • Salt Screens 鈥 Designed to screen for potentially suitable salts to improve physical properties, solubility, or stability of the drug substance. Selected salts may be scaled up for further studies (preformulation developability, stability)
  • Co-crystal Screens 鈥 Designed to discover co-crystals composed of drug substance and pharmaceutically acceptable cocrystal formers, to improve properties of the drug substance by increasing solubility, improving stability etc.

Back to top

KEY INSTRUMENTATION

  • HPLC – UV, DAD, IC
  • PXRD with variable temperature accessory
  • Single Crystal X-ray Diffraction (through a third-party partner)
  • PLM with hot stage accessory
  • Visual Melting Point apparatus with camera
  • SEM
  • FT-Raman and FT-IR (ATR)
  • DSC, TGA, TGA-IR (IR allows identification of evolved gases from TGA)
  • Gravimetric Vapor Sorption (Dynamic Vapor Sorption)
  • NMR (for purity evaluation and salt and cocrystal stoichiometry)
  • Laser Diffraction (for particle size analysis)
  • Image Analyzer (for particle size analysis)
  • Vacuum centrifuge
  • Others (Lyophilizers, fiber optic dissolution, stability chambers etc.)

Back to top

ADDITIONAL INSTRUMENTATION

  • Lyophilizers
  • Jacketed Reactor (up to 2 L)
  • Pion 碌Diss fiber optic dissolution system
  • Suntest CPS+ Light Chamber
  • GMP Stability Chambers
  • Bespoke and off the shelf equipment for handling and processing powders
  • Retsch庐 Ball Mill and Cryo Mill
  • Misc. lab equipment such as rotary evaporator, pH meter, osmometer, viscometers, J-Kem temperature-controlled heating blocks, custom heat/cool apparatus, vacuum ovens etc.

Back to top

WHY CATALENT

Accelerated Approach high throughput API screening platform that will help accelerate your development and optimization of drug molecules.

Expertise highly skilled Ph.D. Scientists with experience characterizing over 1000 compounds spanning from early-stage lead compounds through launched products.

Complete Suite of Analytical Services from early preclinical through clinical and commercial stages, 最新色情影片 delivers a single-provider solution for all your analytical needs.

By using this website you understand and accept that 最新色情影片 tracks your website activities to be able to offer you a more tailored response or information to meet your requirements, and that your personal data will be held in accordance with our聽听触听听触听Cookies Settings.