CMC Analytical

In an era where the science of formulation is advancing medications in new ways, clients require in their portfolio CMC analytical methods handled with a passionate commitment to quality.

Sannova’s team has experience in developing, optimizing, validating, utilizing and transferring:

• Assay methods

• Impurity methods

• Combined assay and Impurity Methods

• Dissolution methods

• Stability Indicating Methods

• Residual Solvent Methods

• Methods for genotoxic impurities.

Sannova has chosen to equip its CMC laboratory with new HPLC’s purchased from the three major HPLC manufacturers. Sannova’s equipment includes Agilent 1260 Infinity, Waters Acuity H series UPLC, and Shimadzu’s AD20 UFLC systems. This affords maximal flexibility for clients who possess their own labs and wish to engage in method transfer or who wish to conduct initial method development in their own labs, followed by optimization and/or validation at Sannova. The same flexibility applies in cases where the sponsor would like to transfer methods developed and validated at Sannova back to the sponsor’s labs.

Similarly, Sannova utilizes Agilent 708DS and Distek 6300 dissolution systems. Additional dissolution equipment includes the Distek EZ Fill 4500 system that allows for fast, reproducible and accurate media preparation, and the Agilent 850 sampling station which allows for automated sample collection for extended release formulations.

GC work at Sannova utilizes the modern Agilent 5977A instrument, fitted with the 7697A headspace unit.

The Agilent 7900 ICP-MS and Milestone Ultrawave digestion system are available for metal impurity analysis according to USP <232>, USP<233> or other protocols.

At Sannova, the ICH stability chambers are continuously monitored for temperature and humidity limits by the Sensaphone alarm system which will notify via cell phone, a series of six Sannova sample management team members, in case of an off hours outage. Gas powered generators also back up Sannova’s stability chambers in the rare case of a power outage.

Sannovians have broad experience in CMC field, having solved difficult analytical challenges for clients.