Pharmaceutical & Chemical Manufacturing Analysis Services

Supporting Australia’s Pharmaceutical and Chemical Industries with Advanced Analytical Solutions

Leeder Analytical provides specialised chemical analysis and troubleshooting services tailored to the pharmaceutical and chemical manufacturing industries. With over 35 years of experience, we deliver the expertise and cutting-edge instrumentation necessary to meet the exacting requirements of pharmaceutical production and chemical manufacturing processes.

Why Choose Leeder Analytical for Pharmaceutical & Chemical Manufacturing?

  • NATA Accredited Laboratory: Certified under ISO17025, ensuring compliance with international quality standards essential for pharmaceutical and chemical manufacturing operations.
  • Industry Expertise: Deep understanding of pharmaceutical and chemical manufacturing processes, with specialised knowledge in troubleshooting and quality control.
  • Advanced Instrumentation: State-of-the-art analytical equipment providing precise, reliable results for complex chemical analysis and quality assurance.

Our Comprehensive Services Include:

Process Optimisation

  • Process Impurity Identification
    Using advanced techniques like high-resolution LC-MS/MS analysis to detect and characterise trace-level impurities in complex matrices.
  • Manufacturing Troubleshooting
    Identifying the root causes of off-spec results or process failures through targeted chemical and structural investigations.
  • Process Validation Support
    Providing analytical data and method validation to support GMP-compliant process qualification and validation stages.
  • Yield Optimisation Analysis
    Evaluating conversion efficiency and pinpointing losses across production stages to improve yield and cost-efficiency.

Specialised Analysis

  • Residual Solvent Testing
    Quantifying volatile organic compounds in raw materials and finished products using gas chromatography analysis to meet global regulatory limits.
  • Degradation Studies
    Monitoring active ingredient or excipient stability and breakdown products over time, supported by LC-MS/MS capabilities for sensitive detection.
  • Chemical Structure Elucidation
    Determining the molecular structure of unknowns or novel compounds through advanced spectroscopic and chromatographic techniques.
  • Contamination Investigation
    Tracing sources of unexpected substances or cross-contamination events using targeted chemical analysis.

Research & Development Support

  • API Characterisation
    Detailed profiling of active pharmaceutical ingredients to support regulatory submissions and quality assurance.
  • Compatibility Studies
    Assessing chemical and physical interactions between APIs, excipients, and packaging materials.
  • Custom Method Development
    Creating and validating analytical methods tailored to your unique formulation, process, or regulatory requirements.

Project Management & Consulting

Our experienced team provides comprehensive support across every stage of production:

Ready to Optimise Your Manufacturing Process?

Partner with Leeder Analytical for excellence in pharmaceutical and chemical manufacturing analysis. Our team is ready to support your quality control, troubleshooting, and development needs with reliable, accurate, and timely analytical services.

Contact Us

CONTACT US

For a free quote or a discussion on how Leeder Analytical can assist you with analytical testing services or consulting please contact us today via the form below

To talk to our team regarding our services, please call 03 9481 4167