Axxelent Pharma Science Executive Research Development Interview Questions and Answers

LoQ values should be set based on the sensitivity of the analytical method and the required level of detection.

• Determine the sensitivity of the analytical method

• Consider the required level of detection

• Set the LoQ value based on these factors

• LoQ values should be validated through experiments

• LoQ values may vary depending on the sample matrix and the type of analyte

Validation can be started by defining the requirements and creating a validation plan.

• Define the requirements for the product or process

• Create a validation plan that outlines the testing and acceptance criteria

• Perform the validation testing according to the plan

• Document the results and any deviations from the plan

• Review and approve the validation results

HPLC calibration involves preparing standard solutions, injecting them into the system, and adjusting parameters to ensure accurate and precise results.

• Prepare standard solutions of known concentration

• Inject the solutions into the HPLC system

• Adjust parameters such as flow rate, column temperature, and detector wavelength to optimize separation and sensitivity

• Calculate calibration curves and determine the linearity, acc...read more