Assay Methods, Related Substances & Residual Solvents
Sannova’s scientific team utilizes broad experience in forced degradation studies, acid/base, heat, light, and oxidative stress, and as necessary, other techniques to identify and focus upon those impurities in an API or formulation that are relevant in formulations, no matter the complexity and route of administration. Included in Sannova’s capability is GC/FID/MS for residual solvents and volatile impurities and when possible we also develop combined assay and impurities methods for efficiency.
Sannova has chosen to equip its CMC laboratory with HPLC’s purchased from the three major HPLC manufacturers, Agilent, Waters, and Shimadzu’s for maximal flexibility for those who 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.
In recent years, the world has seen how unintentional adulterants can pose significant risks to the public, as well as generating significant risks to drug availability, not to mention the profitability of companies serving the world’s pharmaceutical needs. Sannova actively works to develop and validate methods designed to address these issues across organic and inorganic impurities, genotoxic impurities, nitrosamine impurities, metal impurities (USP <232> and <233>) and more as such designated by regulatory authorities worldwide. For example Sannova proactively worked to develop and validate the initial FDA methods for N-nitrosodimethyl amine using its modern Agilent 5977A GC instrument, which is also fitted with the 7697A headspace unit to address genotoxins like small aliphatic halides.
For toxic metals, Sannova has broad experience in using its Agilent 7900 ICP-MS and Milestone Ultrawave digestion system available for metal impurity analysis according to USP <232>, USP<233> to address all elemental impurities in each of the three classes designated by regulatory authorities worldwide.
The Sannovian team has broad experience and state of the art equipment for conducting stability studies, including those for challenging formulations. We maintain a suite of ICH and Non-ICH stability chambers for your stability studies that may require customized conditions as well as a modern Caron Chamber for photostability determination.
All systems are continuously monitored for temperature and humidity limits by the Sensaphone alarm system. This system 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.
Additional CMC Capabilities
- Ion Chromatography
- Particle Size Determination