Strem Chemicals has recently made investments in its quality control and manufacturing capability at its Newburyport, MA facility. A quality control laboratory has been designed and built with electronically monitored and controlled environmental and support equipment. The facility allows operation of validated laboratory release test procedures using both wet chemistry methods and instrumentation, such as HPLC, UPLC, GC, FTIR, UV/VIS, KF water titrations, and melting point. The laboratory provides services for both GMP and non-GMP products.
For Strem APIs manufactured under GMP controls, the laboratory currently analyzes raw materials, in-process samples, cleaning samples and method development samples. An environmental chamber is used to conduct long-term stability studies on Strem API products. The laboratory was inspected by the FDA in 2016.
Strem’s quality control staff performs analytical test
Strem’s newly expanded analytical facility