The Analytics group can analyze your most difficult samples. Some materials require a license or special handling procedures.
We maintain a Nuclear Regulatory Commission (NRC) license to handle five elemental isotopes, including three of the most common isotopes in the pharmaceutical industry, C14, H3, and I125. This license allows our laboratory analysts to process the samples and to analyze them with HPLC instruments that incorporate radiochemical detectors. Carbon-14 studies are a key part of the clinical pharmacology section of the Common Technical Document (CTD) or New Drug Application (NDA).
We maintain a Drug Enforcement Administration (DEA) license to work in the US and a Home Office License to work in the UK with controlled substances.
Our activities in this area include:
- Inspections
- Security
- Training
- Inventory
- Record keeping
- Shipping
- Disposal of controlled substances
We can formulate, manufacture, package, and analyze these compounds.
Our potent drug manufacturing suite and our trained staff of formulators and analytical scientists can formulate and analyze your potent drug substances and drug products. These potent substances have an occupational exposure limit (OEL) of less than one microgram per cubic meter and are often referred to as Hazard Category 4 or 5 compounds.