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IPC & QC Testing |
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The role of Quality Control is
to ensure that only products meeting all the required standards and
specifications are released from our facility. To establish this guarantee,
analytical tests are performed on the raw materials, process intermediates
and final active pharmaceutical ingredients. Our scientists are skilled in
chromatographic techniques and use high pressure liquid and gas
chromatographs to determine the purity of known and unknown components in
the drugs. Other types of analysis and instrumentation include: infrared
spectroscopy, Karl Fisher titration, bulk density analysis, BET surface area
analysis, particle size analysis and wet chemistry techniques. The results
obtained from these tests are compared to previously assigned limits and
must comply with these limits in order to be deemed acceptable for use.
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The In-Process
Control Lab provides around-the-clock analytical support to our
manufacturing processes by performing testing per established methods to
ensure Manufacturing processes are running within allowable parameters. This
testing predominantly consists of performing chromatographic analysis on
process streams, but also may include other analytical techniques such as UV-Vis,
FTIR, IMS and wet chemistry. It also includes testing of non-routine
samples designed to monitor mass balances, environmental monitoring, support
process improvements and process troubleshooting. |
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