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Forced Degradation (1) HPLC (8) ICH (17) Lifecycle (11) Method development (3) Methods (1) MHRA (1) MTS (7) MTS Helpdesk (14) OOS/OOT (2) Procedures (1) Stability (3) Troubleshooting (1) Validation (19) Verification (1) Video (4) Webinar (2)
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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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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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Limit of Quantitation: Does it Matter?
MTS HELPDESK: Is the limit of quantitation always important when validating methods for impurities?
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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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How Long to Equlibrate an HPLC Column?
MTS HELPDESK: How long does it take to equilibrate a column on an HPLC system before the first injection can be performed?
Forced Degradation (1) HPLC (8) ICH (17) Lifecycle (11) Method development (3) Methods (1) MHRA (1) MTS (7) MTS Helpdesk (14) OOS/OOT (2) Procedures (1) Stability (3) Troubleshooting (1) Validation (19) Verification (1) Video (4) Webinar (2)