Chemical Analysis

Smither supports the pharmaceutical and medical device sectors with expert advice, troubleshooting and testing from our FDA registered and inspected laboratories at the UGL.

Extractables testing

We assess the substances which migrate from drug product and packaging materials potentially affecting the safety or efficacy of drug products and how to address them. We offer comprehensive extractables and leachables testing and profiling of container-closure systems (CCS) to fulfill the global regulatory requirement for container closure integrity testing (CCIT) as outlined by USP and ICH.

Analysis

We have an ISO 17025:2005 accredited and ISO inspected and passed a number of validation techniques to examine the chemical properties of products and APIs.

Pharmacopeial Impurities (PGIs)

For quality assessments and strict control of potential genotoxic impurities (GTI) drug substances and products as introduced during the manufacturing process of active pharmaceutical ingredients (APIs), Smither can validate screening process methods and establish procedures to help requirements raised by FDA.

Impurities and Contamination Analysis

As a pharmaceutical and medical device laboratory, Smither can conduct analysis on a premise. Our facilities support chemical analysis ensures of detection and separation or support of ISO 13984.

Data Pharmaceutical Testing

We can assist you with trouble shooting a wide range of problems or encountered difficulties in materials packaging and drug products. Our labs take a great deal of ensuring high quality data and we offer an expedited service when needed.