Recognized as a CRO for pharmaceutical formulation, CD Formulation recently announces to have optimized its stability analysis service, providing solid-state stability analysis, solution-state stability analysis, APIs-excipients compatibility analysis for researchers devoted to drug formulation research. Current Good Manufacturing Practice for Finished Pharmaceuticals (CGMPs) has already established requirements on the expiration date and stability testing of drug products to assure the appropriateness of that date.
"Stability analysis is of vital importance because it can help prove and ensure the product quality, safety and efficacy of drug products when exposed to environmental factors such as temperature, humidity and light. Any drugs need stability testing documents before they are accepted and approved by regulatory agencies. At CD Formulation, we conduct stability studies in a planned way following the guidelines issued by ICH, WHO and or other agencies," says the Marketing Chief of CD Formulation. "Our methods for stability analysis include but are not limited to Thermogravimetric Analysis (TG), Raman Spectroscopy, FT-IR Spectroscopy, Differential Scanning Calorimetry (DSC), High-performance Liquid Chromatography (HPLC), and X-ray Diffraction."
After elucidating how the chemical, physical and microbiological changes will influence the effectiveness, stability and safety of the final drug product and make recommendations on how to best store drugs, scientists at CD Formulation will also help clients to make a decision for operational and procedural conditions that can ensure the physical and chemical stability and pharmacological activity of the product to minimize potential formulation and stability issues.
Besides stability analysis, CD Formulation also provides other pre-formulation services like crystallinity determination, amorphous content determination, hygroscopicity evaluation, particle size analysis, moisture content determination, solubility analysis, LogP/LogD/pKa analysis, stability analysis, and API-excipient compatibility for pharmaceutical companies. Visit: https://www.formulationbio.com/preformulation.html to learn more information.
About CD Formulation
The increasing demand for greater flexibility and efficiency in drug development has made innovative drug formulations more valuable. Although challenges and difficulties still exist, more and more studies have been focused on a more intelligent approach to excipient design in the hope to address the long-standing issue of poor solubility and bioavailability of newer APIs. Equipped with a group of experienced staff, CD Formulation is working closely with the pharmaceutical industry as a contract service organization, offering outstanding expertise to handle the most complex drug formulation issues.