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"...
by maheshbhuva | Dec 26, 2022 | Analytical Chemistry, Method validation
• Ich Q2(R1) guidelines • 〈1224〉 TRANSFER ANALYTICAL PROCEDUR • (Transfer between laboratory to laboratory) • <1225>VALIDATION OF COMPENDIAL PROCEDURES Chromatography focus this chapter • <1226>VERIFICATION OF COMPENDIAL PROCEDURES Method suitable and time...
by maheshbhuva | Dec 25, 2022 | Analytical Chemistry, Hplc, Method validation
Accuracy is also part of method validation different place Different terminology used for accuracy like recovery, truth value, biaus etc Accuracy mainly defined Result of testing compound how much near by truth value. Example: take azithromycin tablet 500 mg Assume...
by maheshbhuva | Dec 25, 2022 | Hplc, Method validation
It t part of analytical method validation Definition: Specificity to defined capability to assess unequivocally the analyte in the presence of components which may be expected to be present. They might be impurities, degradants, matrix, etc. Here we identify that Any...
