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Article (3) Forced Degradation (1) HPLC (7) ICH (6) Lifecycle (2) Method development (1) Methods (1) MTS (1) MTS Helpdesk (4) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (10) Video (4) Webinar (2)

  • ICH Updates in Our Validation Courses

    Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. We have modified our courses, ‘Validation, Verification & Transfer of Methods for Pharmaceutical Analysis,’ and, ‘Validation, Verification & Transfer of Methods for Biopharmaceutical Analysis‘, to ensure that […]

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    ICH Updates in Our Validation Courses
  • JPAG Symposium: Stability VI

    The MTS consultant, Oona McPolin, will deliver a presentation entitled, ‘Challenges in Development and Validation of Stability Indicating Methodology‘ at the JPAG symposium, ‘Stability VI’ on the 30th June 2022, which will be held at the Royal Society of Chemistry in Burlington House, London. If you are interested in the analytical methodology used for supporting […]

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    JPAG Symposium: Stability VI
  • Limit of Quantitation: Does it Matter?

    Defined as “the  lowest amount of analyte  in a  sample which  can be quantitatively determined with  suitable precision and  accuracy” in ICH Q2(R1), limit of quantitation (or ‘quantitation limit’ in the ICH terminology) is an important method performance characteristic which is typically demonstrated during analytical method validation. Although the concept of limit of quantitation (LOQ) […]

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    Limit of Quantitation: Does it Matter?
  • Drafts of ICH Q2(R2) and Q14 on Public Consultation

    Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. The deadline for comments is 31st July 2022. You can view the draft guidelines, and also a presentation from ICH about the guidelines, using the following links: […]

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    Drafts of ICH Q2(R2) and Q14 on Public Consultation
  • How Long to Equlibrate an HPLC Column?

    This is a question commonly asked by HPLC analysts, particularly those relatively new to the technique. The range of currently available column dimensions means that a ‘one size fits all’ approach is not appropriate. The amount of mobile phase which should be flushed through a column before it is ready to use is usually expressed […]

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    How Long to Equlibrate an HPLC Column?

Article (3) Forced Degradation (1) HPLC (7) ICH (6) Lifecycle (2) Method development (1) Methods (1) MTS (1) MTS Helpdesk (4) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (10) Video (4) Webinar (2)