At ADEPT, we understand the critical needs of our national and internationally valued customers. ADEPT is a niche of highly skilled and qualified formulators and developers, who will develop stable, robustÂ and compliant formulations. We offer the following specific studies and propose to formulation andÂ Development.
Bulk drug characterization:
Common ion effect
pH stability Profile
Solid state stability
Container and closure Interactions
Container content compatibility study is indispensible as a part of new product market authorization file submission to regulators in US, Europe and Japan .We at ADEPT follow cGMP, CPSC and USP Requirements on Containers and Closures. Following are quality control tests for containers and closures, performed at ADEPT to ensure quality, safety and efficacy of the formulations.
Drug and excipients compatibility
Complete characterization and physicochemical interaction of active pharmaceutical ingredient with that of the excipients are carried out at ADEPT to ensure consistent efficacy, stability and safety. Drug excipients compatibility (DEC) studies data is mandatory for investigational new drug (IND) application for USFDA. We here at ADEPT perform the following testes to address the complex DEC related issues leading to physical and chemical instability of the formulations.
Thermal Methods of Analysis
Formulation and Development
We are integrated formulations and development service provider for our clients ensuring End to End clarification. We provide solutions to all types challenges occurs in drug development and formulation/ method development etc. to unstable drug candidates (Majorly ester and amide linked molecules). We are proficient in: