Raw Materials Group doubles

The staff of the Pharmaceutical Raw Materials Group has gone from 21 to 42, and the laboratory space allotted to the group’s activities has roughly doubled. Darla Schumacher, manager of the group, attributes the overall growth to the exceptionally wide array of analytical testing offered. Kathy Soltysik, chemist, determines the CHN content of a new drug product. “Clients appreciate the vast capabilities our size and expertise allow us to offer,” Schumacher adds. “And our high standards of quality and efficiency helped our sales to increase by 56 percent last year. We’ve been able to study our systems and cut our turn-around time from 15 to 10 days. That’s especially attractive to our growing list of clients.” “Small labs lack the resources, equipment, and lab-wide expertise that a laboratory our size can provide,” says Schumacher. “For instance, we recently acquired ICP (Inductively Coupled Plasma) equipment that is often used to help clients determine contamination sources. The equipment operates at peak, also performing feasibility studies, method development, and validation of ICP methods for pharmaceutical manufacturers.” Another newer addition to the group is the CHN (Carbon/Hydrogen/Nitrogen) analyzer. Pharmaceutical manufacturers often request CHN testing for information in their research and development efforts. The group performs testing according to the USP (United States Pharmacopeia), Ph Eur (European Pharmacopeia), the BP (British Pharmacopeia), and the JP (Japanese Pharmacopeia) methods. The group also does analyses according to the ACS (American Chemical Society) and FCC (Food Chemical Codex) guidelines as well as many client-supplied methods.