QPLAB has a fully dedicated area to method development and validation for CMC purposes. Develop and/or validate analytical compendial and non-compendial methods for excipients, APIs, preservatives, intermediate and finished pharmaceutical products, according to the ICH Q2(R1) in line with Q6A, Q6B and FDA guidelines. Once validated, methods are ready to transfer to the contract giver.
Method development
● Based current regulation / guidelines
● Classical techniques (HPLC-UV, GC-HS-FID, UV/Vis spectroscopy, Karl Fisher, Dissolution)
● Innovative techniques (LC-MS/MS)
● Adjusted to customer goals (Residual, Assay, Impurity)
Method validation
● Identification
● Assay testing
● Related Substances
● Residual Solvents
● Impurity testing (specifically, genotoxic impurities)
● Microbiology testing
● Dissolution testing
● Cleaning process validation
Other services