Reduce method development time and support robust, reproducible analytical methods through development, validation, transfer, and routine use with USP- and EP-aligned chiral HPLC solutions and expert support.
Chiral method development can become a time-consuming step in generic drug development, particularly when an established compendial method is not available or does not meet the needs of the application. Daicel Chiral Technologies offers pharmacopeia-aligned (USP/EP) chiral high performance liquid chromatography (HPLC) solutions with established analytical workflows to shorten your development cycle. Four decades of chiral separation expertise and an extensive column portfolio provide your team with the tools to support robust, reproducible analytical methods through development, validation, transfer, and routine use.
Streamline method development:
Pharmacopeia-aligned chiral HPLC workflows that support your generic drug program
Support reproducible methods:
USP- and EP-listed column solutions that meet compendial requirements.
Maximize analytical reproducibility:
Columns engineered for consistent, reliable enantiomer identification across studies and operators
Streamline your path through chiral method development with column solutions and analytical workflows that keep your generic drug program moving forward.
Daicel chiral columns support compliance with major global pharmacopeias, including USP, EP, JP, and IP, providing
your generic drug program with analytical methods aligned to regulatory expectations. With over 1,200 columns and 40+ chiral phases available, your team has the selection needed to match the right column to your compound and your submission requirements.
Review USP codes and chiral selectors on our technical poster.
Not sure whether HPLC or SFC is the right fit for your program? This guide breaks down the key decision factors.
Access +1,900 generic applications.
Every generic pharma submission depends on clean,
defensible chiral analytical data. Daicel Chiral Technologies delivers the column solutions and analytical expertise to support your critical workflows.
Enantiomeric purity testing to establish and quantify enantiomeric purity to meet regulatory thresholds
Impurity profiling for detection and quantification of unwanted enantiomeric impurities
USP monograph analysis using columns aligned with compendial testing procedures
Method validation to establish reproducibility, accuracy, and robustness ahead of submission
Our technical team is ready to address any chiral analytical need for your generic pharmaceutical program. We can provide tailored method recommendations and help you select the right column or stationary phase to support your analytical workflows from development through routine use.
Are you ready to reduce method-development time and establish robust analytical methods?
Use the form below to get started.
