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
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 Here we identify that Any interference found in sample Like you made tablet azithromycine in such a case observer Any interference likePlaceboBlankDegradentSolventsDilution etc ( not affected retention time) Other hplc...
by maheshbhuva | Dec 21, 2022 | Method validation
It t part of analytical method validation Here we identify that Any interference found in sample Like you made tablet azithromycine in such a case observer Any interference like Placebo Blank Degradent Solvents Dilution etc ( not affected retention time) If not any...