Having a research team skilled at tackling highly complex and challenging characterization issues, CD Formulation recently demonstrated its ability to perform physical and chemical characterization services for active pharmaceutical ingredients (APIs) and pharmaceutical products in all stages of the drug development process.   The physicochemical properties of APIs, especially solubility, stability, in vitro dissolution and bioavailability, are of critical importance to pre-formulation as they will not only affect the choice and design of formulation, but also influence the performance of the dosage forms.   “A solid and thorough investigation into the physical and chemical properties of APIs is a primary step for quality control in the pharmaceutical industry,” said the Marketing Chief of CD Formulation. “With state-of-the-art instrumentation, our highly qualified technicians can undertake studies to specify the physicochemical characteristics of APIs as well as their intermediates.”   To test the physical characteristics of APIs, the following testing items should be carried out, including but not limited to XRPD Characterization, Particle Size Determination, Morphological Analysis, Surface Area Analysis, Thermogravimetric Analysis using equipment and methods like Polarizing Microscope (PLM) and Differential Scanning Calorimetry.   In contrast, to test the chemical characteristics of APIs, NMR is utilized to identify the chemical structure and quantify residual solvents. Fourier Transform Infrared and Near-infrared Absorption Spectra are used to scan fingerprints and recognize functional groups in molecular structure. Photoacoustic scanning is used to identify resin and opaque/colored materials. In addition, the Ultraviolet-Visible Absorption Spectrum is used to determine the characteristic absorption mode of raw materials or for qualitative detection, quantitative calculation and kinetic analysis.   “At CD Formulation, our experienced researchers work closely with our customers in designing and conducting pre-formulation studies and offer a wide range of approaches to characterize varieties of drug candidates such as small molecules, peptides or proteins,” a senior scientist further added.   Please visit our website to explore more of CD Formulation’s physical and chemical characterization capabilities.   About CD Formulation During the past few years, CD Formulation has served as a trust-worthy custom service provider for drug pre-formulation and has luckily made commendable achievements owing to its strong expertise and professionalism. Meanwhile, the company also has a track record of success in optimizing different dosage forms to bring the best therapeutic effects out of drug candidates, shortening development timelines as well as extending pharmaceutical product life cycles.

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APIs