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What are the guidelines for method development of hplc according to ich?
the same guidelines for method validation
The criterion-related validation method is generally preferred to other validation approaches because a. it is based on empirical data b. it tends to be less expensive c. it lacks generalizaiton d.?
A
Method validation was done in one column now the column has been changed for sample analysis weatherwe need to perform method validation once again or not?
you need equivalency study only by prepare 6 sample in the tow column (they should be same result)
What is a validation study?
USP definition: "Validation of an analytical method is the process that establishes, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical applications."
What is the procedure for analytical method development and validation process for tenofovir tablets?
once check in indian pharmacopia
Types of validation?
The type of validation used here is calculation validation. It involves using a known measurement (the thickness of a single sheet of paper) and multiplying it by the number of sheets to determine the total thickness. This method is based on the assumption that each sheet of paper has a uniform thickness, which is generally true for standard office paper.
What is current purchasing power accounting method?
What is current purchasing power accounting method
Linearity is how much important in method validation?
its important for recover the calculation equation and for improve linearity equation (pears low )
Why the pH of buffer is not changes in robustness of validation of hplc method?
it must change by (+- 0.3) to have control in pH meter error
What are the five main types of validation checks?
types of validations are: required field validation range validation pattern matching validation database specific validation numeric validation
What is difference between specificity and selectivity in hplc method validation?
Specificity refers to the ability of an analytical method to accurately measure the analyte of interest in the presence of potential interfering substances. Selectivity, on the other hand, refers to the ability of the method to only detect the analyte of interest while ignoring any other components present in the sample. Both are important parameters in HPLC method validation to ensure accurate and reliable results.
How many parameters will perform in analytical cleaning method validation?
linearity, Recovery for soaping , recovery for stainless plate and LOD & LOQ
