Support Services
Mayflower Scientific provides a wide range of technical services to the pharmaceutical and specialty chemical industries.
Method Development High-performance liquid chromatography is one of the core analytical techniques used to test and characterize pharmaceutical compounds – from raw materials to the finished drug product.
We can provide comprehnsive support to your CDMO when developing and qualifying robust chromatgraphic methods that are suitable for R&D, GLP, or GMP manufacturing.
Process Characterization Process monitoring and in-process controls are critical quality measures to ensure your manufacturing process is operating as designed and yields consistent batch-to-batch results. Failed batches can be extemely expensive and lead to significant project delays.
Samples can be tested in-line, at-line, or in a QC lab. These test are designed in conjunction with the process chemist and manufacturing teams.
Stability Stability testing and the corresponding data trending are important tools to help ensure your API and finished DP have acceptable shelf life, expiry, and retest dates.
In-use stability is also needed to ensure your reactive intermediates and raw materials can be safely stored before, and during, manufacturing.
Stability-indicating methods are critical tools to evaluate these materials under various storage conditions (heat, humidity, acid, base, and oxidative stress).
USP/EP/JP Compendial test methods are useful tools and typically require limited verification especially in early development. We can draft the necessary protocols to ensure these are fit-for-purpose and support your project as it evolves and moves through clinical development.
Mutagenic Impurities Mutagens are important to identify and control in all manufacturing processes as outlined in ICH M7. These impurities require very sensitivite and specific analytical methodologies (HPLC-MS, GC-MS), capable of monitoring often at the part-per-billion level. A risk assesment must also be conducted for each synthetic process to evaluate potential nitrosamine formation.