The main activity supported in the new cGMP-compliant laboratory is the testing of clients’ stability samples. Specific testing activity includes:
• Assay and related substances by HPLC (UV and RI) and UPLC-UV;
• Assay by titration; water content (Karl Fisher); pH; viscosity; osmolality; density/specific gravity; disintegration; dissolution and UV; and
• Hardness and friability for tablets
In addition to executing clients’ cGMP stability programs, the laboratory is ideal for the testing of samples for cleaning validation studies, in vitro equivalency determination and test article characterization.
“Our new cGMP analytical laboratory is impressively designed, equipped and staffed so that we can meet our clients’ growing demand for analytical services,” said Dave Barnes, chief executive officer, Velesco. “We look forward to collaborating with our clients to ensure strong cGMP testing programs. Our clients can be confident their testing will exceed FDA compliance requirements.”