Determination of Eight Nitrosamine Impurities
April 17th 2023This application note demonstrates that the Agilent 6475 triple quadrupole LC/MS system can confidently quantify nitrosamine impurities at the low concentration levels specified by regulatory requirements. This method can be used to quantify these impurities in different ARB drug products, with some changes in chromatographic conditions based on the elution pattern of the drug product.
Allowing You to do More with Less: The TRS100 Transmission Raman System
July 21st 2022Thursday, July 21st, 2022 at 11am EDT|8am PDT|4pm BST|5pm CEST Learn about the use of molecular spectroscopy techniques – transmission Raman spectroscopy (TRS) and laser direct infrared (LDIR) – for solid-state analysis in pharmaceutical formulation development.
Extractables and Leachables: Trends and Future Directions Part II A roundtable discussion
May 25th 2022Wednesday, May 25, 2022 at 11am EDT|8am PDT|5pm CEST|4pm BST In the last few years, the issuance of the ISO 10993-18:2020 medical device guidance and several high-profile publications and round robin studies have resulted in the FDA increasing scrutiny of E&L analyses for both drugs and devices. Join our panel of industry experts to discuss these changes and to learn the direction E&L studies may take in the future.
Analytical-Scale Prep, Semi-Prep, Process Scale Preparative Chromatography: To Infinity and Beyond!
October 26th 2021Tuesday, October 26, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST Are you planning to turn your analytical HPLC method into a purification method? Are you converting your analytical-scale purification method to semi-prep or production scale? Learn how to set appropriate purification goals for purity, yield and throughput and what type of equipment will best fit your application.
Extractables and Leachables: Trends and Future Directions A roundtable discussion
September 28th 2021Tuesday, September 28, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST In the last few years, the issuance of the ISO 10993-18:2020 medical device guidance and several high-profile publications and round-robin studies have resulted in the FDA increasing scrutiny of E&L analyses for both drugs and devices. Join our panel of industry experts to discuss these changes and to learn the direction E&L may take into the future.
Pharma Quality Control Testing
October 11th 2019Quality control plays a major role in the development of safe, high-quality pharmaceutical products. This PharmTech eBook on Pharma Quality Control Testing helps laboratories ensure they are up to date on the latest tools and techniques for achieving precise and efficient results in QC testing.