With over 10 years industry experience per structural scientist, Nitto Avecia Pharma Services’ strategic, systematic approach provides high quality solutions for identification, characterization, and development of highly sensitive methodologies.
Regulations make extractables and leachables studies an essential part of your development process. Investigate the potentially harmful effects of your container/closure system on your drug product to assist in identifying the threat of contamination.
This presentation discusses the basic definitions of extractables and leachables, how applying specific methods and techniques can allow you to detect extractables and/or leachables, and two case studies that provide insight into the variables and challenges faced when detecting extractables and/or leachables.
Utilizing our USP/ICH compliant, state-of-the-art laboratory, Nitto Avecia Pharma Services is capable of detection, profiling, and control support of all three classes of residual solvents in drug substances, excipients, and drug products. Rapid analysis, identification, and quantification of impurities is completed in strict compliance of ICH guidelines.
Nitto Avecia Pharma Services has nearly 30 years of analytical experience with USP General Chapter for Heavy Metals <231> and our staff can help you develop/transfer, validate, and test the elements listed in <232> and beyond.