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...
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...
