by maheshbhuva | May 5, 2025 | Analytical Chemistry, Analytical method development hplc,, Method validation, Pharmaceutical interview,, Quality control (QC), stability
Ah, method validation planning in pharma – a cornerstone of ensuring the quality and reliability of pharmaceutical products! It’s all about demonstrating that your analytical methods are fit for their intended purpose.To get started with effective method...
by maheshbhuva | May 13, 2024 | Analytical Chemistry, Analytical method development hplc,, Method validation, Quality control (QC)
Type of analytical procedure validated Identification tests. Quantitative tests for impurities’ content. Limit tests for the control of impurities. Quantitative tests of the active moiety in samples of drug substance or drug product or other selected...
by maheshbhuva | Mar 9, 2023 | Method validation
Specificity As per ICH Q2A guideline defined as Specificity is the ability to assess unequivocally analyte in the present of component which may expected to present. Typically these might include impuries, degradants, matrix etc Selectivity The extent to which the...
by maheshbhuva | Feb 26, 2023 | Method validation
FORCED DEGRADATION: ICH: a2R1) VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY ANVISA: CoLLEGIATE BOARD RESOLUTION – RDC No. 53, OF DECEMBER 4, 2015 Topic: metal ion catalysed oxidation ICHNOT required ANVISARequired analysis cu 2+, Fe 3+(accelerate,...
by maheshbhuva | Jan 5, 2023 | Analytical Chemistry, Method validation
• the requirements of the measurement procedure• scope of experiments• RM to be used• Equipment• Statistical tools to be used• personnel for performing experiments and evaluating obtainedresults Analytical method validation Share this: Click to share on Facebook...
by maheshbhuva | Dec 27, 2022 | Analytical Chemistry, Method validation
Precision main three parts Repeatability Intermediate precision reproducibility precision style="display:block" data-ad-format="autorelaxed" data-ad-client="ca-pub-2005197227015372" data-ad-slot="6180173655" style="display:block" data-ad-format="autorelaxed"...
