Pharmaceutical Dissolution Testing – Sampling and Assay

  • Product Id : FDB2603
  • Category : , ,
  • Presenter :
  • Scheduled On : October 16 2018 9:00 am
  • Duration : 60 Minutes


    US and Canada
    9 AM EDT

    Central Europe
    3 PM CEST

    UK and Ireland
    2 PM BST/IST
    .

Pharmaceutical dissolution testing plays an important part in the quality control of solid oral drug products. This webinar will help attendees to avoid common mistakes in dissolution sampling and assay that might decrease confidence in the data or lead to a failure to comply with compendial requirements.

Areas Covered in the Session :

– Dissolution testing and drug product safety/efficacy

– Dissolution sampling

  • Compendial requirements
    • Time interval
    • Sampling position
    • Filtration
  • Observations
  • Loss of analyte through adsorption
  • Choice of sample filter
  • Is centrifugation acceptable?
  • Dissolution medium replacement – when and how
  • Automation

– Dissolution assay

  • Choice of assay/detection technique
    • UV
    • HPLC
  • Correcting for sample volume in the assay calculation
    • No dissolution medium replacement
    • Dissolution medium replacement

Who Should Attend:

  • Analytical Management Teams
  • Method Development Teams
  • Quality Control Departments
  • Quality Assurance Departments

FDB2603

Dr. Mark Powell

Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team. He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements.

He also provides training services, which are accredited by the UK’s vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.