Deformulation (Reverse Engineering) Analysis Services

Deformulation analysis, also known as reverse engineering, is a product design technology reproduction process, which is a reverse analysis and research on a target product. The purpose is to deduce and derive the design elements of the product, such as processing flow, organizational structure, functional characteristics and technical specifications, etc., and then to produce products with similar functions but not exactly the same. Deformulation analysis can be used in a variety of industries and is widely recognized in the product development cycle, as is the pharmaceutical and medical device industries. For generic manufacturers, deformulation analysis of pharmaceutical formulations can yield a wealth of critical information to obtain generics with appearance, prescription composition, and process similar to the original drug, saving a lot of time and money.

Deformulation research is a complex process that requires the analysis of primary and secondary components using a variety of analytical instruments, analytical techniques, and extraction methods. Alfa Chemistry's experts have extensive experience in deformulation analysis of pharmaceutical and medical devices. Our laboratories are equipped with world-class laboratory equipment to solve your research problems and obtain valuable product improvement information to reduce production costs while improving product quality.

Alfa Chemistry's deformulation analysis services include but not limited to:

• Analyze Competitor Products - Identify and quantify all components of a formulation through deformulation analysis to obtain valuable product information.

• Patent Infringement Analysis - Perform deformulation analysis to confirm whether your formula violates existing patents and confirm whether competitors have infringed your intellectual property rights.

• Improve Existing Product Performance - Compare existing products with advanced products in the industry to improve the performance of existing products.

• Identification of Hazardous Compounds - Unsafe or regulatoryly banned ingredients or substances in the formulation can be found by deformulation analysis.

Equipment for deformulation analysis includes but not limited to:

• Fourier Transform Infrared Spectroscopy (FT-IR)

• Thermo Gravimetric Analyzer (TGA)

• Scanning Electron Microscope/Energy Dispersive X-Ray (SEM/EDXA)

• X-Ray Diffraction (XRD)

• Liquid Chromatography-Mass Spectroscopy (LC-MS)

• Gas Chromatography-Mass Spectroscopy (GC-MS)

• Induced Coupled Plasma (ICP)

• Nuclear Magnetic Resonance (NMR)

Alfa Chemistry's advantages:

Alfa Chemistry has experienced and skilled scientists to provide customers with a satisfactory report on the deformulation of pharmaceuticals and medical devices. If you encounter any problems during the production process, our team is ready to provide deformulation services for you.