Deformulation of Pharmaceuticals
Chemir's chemists have deformulated or reverse engineered hundreds of pharmaceutical, medical device and drug products. Also known as reverse engineering, deformulation is the separation, identification and quantitation of ingredients in a formulation.
Pharmaceutical deformulation can be used for:
- Competitive product characterization
- Development of generic drug products
- Identification of batch to batch variations
- Comparative analysis of "good" and "bad" samples
- Patent infringement or trade secret investigations
Deformulation analysis uses instrumental techniques and conventional extraction methods to identify and quantify the components of a complex mixture. Although we do not guarantee a "cookbook recipe", our analysis in most instances identifies the chemical class of major and minor components. A computer library search is also performed when needed to locate the trade names of similar, commercially-available materials.
Our experienced chemists are kept up-to-date with the latest methods and have developed techniques for unraveling complicated formulations.
Deformulation analysis of commercial products is provided for informational purposes only. Chemir strongly recommends review of state and federal laws, trademarks, copyrights and patent situations by the customer prior to use of such information.
