Waters applications for method development and validation  

Application notes:

• A Systematic Approach Towards UPLC Methods Development (720002338EN)
• Transitioning Existing LC Methods to New Technologies: Choosing an LC Platform for 2012 (720001902EN)
• Transfer of the USP Assay for Simvastatin to UPLC (720001901EN)
• Transfer of the USP Assay for Amoxicillin and Potassium Clavulante from an Oral Suspension to UPLC (720002043EN)
• Addressing the Challenges of Complex Mixture Analysis with Sub-2 micron Particle LC: Long Columns and High Temperatures (720002411EN)

Articles:

• Automation of the Chromatographic Analytical Method Validation Process (Validation Viewpoint, LCGC North America; 720001528EN)
• Implementing New Technology in a Regulated Environment (LCGC North America)
• Analytical Method Equivalency: An Acceptable Analytical Practice (Pharmaceutical Technology)
• Development and Validation of a UHPLC Method for Paroxetine Hydrochloride (LCGC North America)
• Ultra Performance LC: Separation Science Redefined (LCGC North America; 720001136EN), including:
  • Ultra Performance Liquid Chromatography (UPLC): An Introduction
  • The Use of ACQUITY UPLC in Pharmaceutical Development
  • UPLC Coupled to Orthogonal Quadrupole TOF-MS for Metabolite Identification
  • Assay Transfer from HPLC to UPLC for Higher Analysis Throughput
  • The Evaluation and Application of UPLC for the Rapid Analysis of Dose Formulations
  • Developing Columns for UPLC: Design Considerations and Recent Developments

Wall charts:

• Method Validation (720001826EN)
• Selecting a Liquid Chromatography Column (720002241EN)
• Strategies for Efficient Reversed-Phase Method Development (720001978EN)

Specific analyses requiring the method development, performed throughout lead optimization, candidate selection and confirmation, and clinical R&D.

Method scouting

• A Review of Waters Particle Technology, Part 2: BEH Technology Hybrids and their use in Liquid Chromatography (720001159EN)

Forced degradation

• Utilizing UPLC/MS for Conducting Forced Degradation Studies (720002259EN)

Impurity profile

• UPLC and Empower 2 CDS for Efficient Method Development of an Impurity Profile of Simvastatin and its Related Impurities (720002185EN)
• Identification of the Impurities of Simvastatin Using Exact Mass UPLC/MS (720002306EN)

Stability

• Characterization and Quantitative Determination of Impurities in Piperaquine Phosphate by HPLC and LC/MS/MS (J. Pharm Biomed Anal.)

Formulation development

• Quantitation of Over-the-Counter Cold Medicine Formulations using UPLC (720002005EN)

Method validation

• ACQUITY UPLC System: Better Utilizing Assets in a Small Laboratory Environment with UPLC (720002328EN)
• Empower 2 Method Validation Manager: Tool for Rapid Method Validation (720002401EN)
• Empower 2 Method Validation Manager: Streamlining Method Validation in Pharmaceutical Product Development (720001522EN)
• Streamline the Chromatographic Method Validation Process Using Empower 2 Method Validation Manager (720002319EN)
• Automation of the Analytical Method Validation Process (Validation Viewpoint, LCGC, 720001528EN)

Transfer to QC

• NuGenesis SDMS: Optimizing Efficiency with Electronic Regulatory Submissions (720001359EN)
• Waters SystemsQT: Automated Qualification Tool for Waters Systems (720002271EN)
• Connections INSIGHT: Reducing Instrument Down-Time in an Analytical Laboratory (720001602EN)