Manufacturers of generic drugs must be able to prove that the compounds they produce are comparable to the brand-name drug while maintaining and/or improving the cost effectiveness of the drug’s production.
Generic drug producers refer to the United States Pharmacopeia-National Formulary (USP-NF), as well as the British, European, and Japanese Pharmacopeias for information on how to analyze drug substance, drug product, and associated excipients using various analytical techniques such as high performance liquid chromatography (HPLC).
With the USP's initiative to modernize compendial methods to modern analytical technology, there are opportunities for generics QC labs to upgrade technologies and methods.
- UPLC enables the use of sub-2-μm particle columns with smaller inner diameters (≤ 3.0 mm) and short lengths (50 to 100 mm) on high pressure instrumentation. As a result, lower flow rates and shorter run times are used, reducing solvent and sample consumption and disposal.
- Generic pharmaceutical organizations around the world are successfully converting HPLC Compendial Methods to UPLC to achieve higher throughput, lower costs, and faster time-to-market for routine analysis of generic drugs.
- The same HPLC resolution and selectivity to meet compendial standards can be achieved in less time with an ACQUITY UPLC H-Class System and Waters' flexible UPLC column formats, saving time and money associated with method development and routine analysis of drug substances and drug products.
- The ACQUITY UPLC H-Class System is additionally able to run both HPLC and UPLC assays without instrument modification, and with features like a quaternary pump and AutoBlend Technology to automatically manage the formulation of mobile phases, can improve reproducibility and consistency in results.
Complementing our analytical technologies for generic pharmaceutical QC labs are Waters' informatics products, smart tools that will help your laboratory operate more efficiently
- Empower 3 Chromatography Data Software, the industry-leading CDS for regulated environments
- NuGenesis 8 Featuring LE Technologies, a compliant-ready data repository and ELN, a flexible analytical electronic laboratory notebook
- Select the Related Products tab to learn more about these individual products.
- Choose the Application Notes tab to learn how to transfer HPLC methods to UPLC.
