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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


What is declarative form validation and programatic form validation?

Declarative form validation involves defining validation rules directly within the markup or structure of a form, often using attributes or annotations to specify constraints. This approach allows for automatic handling of validation by the framework or library being used, making it easier to read and maintain. In contrast, programmatic form validation involves writing custom validation logic in the code, allowing for more complex and dynamic validation scenarios tailored to specific requirements. This method offers greater flexibility but can increase complexity in implementation.


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


What is the purpose to see method?

The purpose of the see method is to provide a way to inspect or view the details of an object, variable, or data structure in programming. It helps developers understand the current state and values during debugging or testing. By using this method, developers can identify issues or verify that the code is functioning as intended. This can enhance the overall development process by facilitating easier troubleshooting and validation.


What is Hybrid system in validation?

A hybrid system in validation refers to an approach that combines both traditional and modern validation techniques to ensure the accuracy and reliability of processes or products. This may involve integrating manual validation methods with automated tools or utilizing a mix of simulation and real-world testing. The goal is to leverage the strengths of each method to achieve comprehensive validation while optimizing resources and efficiency. Hybrid systems are particularly useful in complex environments where different types of data and validation requirements coexist.


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


Linearity is how much important in method validation?

its important for recover the calculation equation and for improve linearity equation (pears low )