Impurity identification is the process of elucidating the nature of unknown materials in combination products, medical devices, pharmaceuticals, or consumer products using a variety of analytical techniques.
Isolation and Identification of Unknown Components and Impurities
The presence of an unknown component or impurity at even trace levels can cause irreparable damage to a product, rendering it unusable depending on the product application. Impact Analytical can assist with the identification of impurities that are detected during the analysis of a product or that cause product performance issues, such as color bodies in a sample. Unknown components and impurities can appear from several sources. The full breadth of analytical capabilities at Impact Analytical and over 10 years of experience characterizing unknowns and impurities enable us to solve these tough problems. Our laboratory is equipped with the most advanced instrumentation to identify impurities. We have proven methodologies for specific material types that allow us to efficiently isolate and identify the component, ultimately determining the source of the impurity.
Unknown and impure materials can come from numerous sources, including:
- API and/or Non-Active Component Degradation
- Oxidized Polymer Additives
- Unreacted Monomers/Oligomers
- Product Containers (i.e., Leachables)
The Process for the Identification of Impurities
When you work with us, our experts will first consult with you to discuss the objectives for the project and gather any available information about the product. Background information about the product can greatly aid in the identification of the impurity as well as reduce the time required for the project. Our experts will work you and will work internally to develop the most efficient analysis plan and to select the most appropriate techniques for the project.
Techniques Used for the Process
Most impurity analyses will require some separation of components within the sample. Advanced instrumentation available at Impact Analytical can be used to separate sample components and to identify the impurity. Our instrumentation includes LC-MS, GC-MS, NMR, FT-IR, ICP, and several other instruments. LC-MS can provide accurate mass information on less volatile impurities, which leads to a timely structural assignment. LC-MS can also detect compounds without UV chromophores that would not be detected by HPLC-UV. GC-MS can detect more volatile components. Other techniques mentioned above can also be used for the identification once the impurity has been isolated. Only the most appropriated techniques will be used for the project helping you to manage the cost of the project.