Ajanta Pharma Quality Analyst Interview Questions and Answers

pH is a measure of acidity or alkalinity of a solution. It is measured on a scale of 0 to 14.

• pH stands for 'potential of Hydrogen'

• It is a measure of the concentration of hydrogen ions in a solution

• A pH of 7 is considered neutral, below 7 is acidic, and above 7 is alkaline

• pH can be measured using pH meters, pH paper/strips, or pH indicators

Calibration ensures accuracy of instruments by comparing measurements to a known standard.

• Calibration is the process of adjusting an instrument to ensure its measurements are accurate.

• Principles of instruments include accuracy, precision, repeatability, and reproducibility.

• Examples of calibrated instruments include thermometers, scales, and pressure gauges.

Investigation tools are used to analyze data and identify issues in software development.

• Common investigation tools include debuggers, profilers, and log analyzers.

• Debuggers help identify and fix coding errors by allowing developers to step through code and inspect variables.

• Profilers analyze the performance of code, identifying bottlenecks and areas for optimization.

• Log analyzers parse and analyze log files to identif...read more

Troubleshooting of HPLC system involves identifying and resolving issues to ensure accurate and reliable results.

• Check for leaks in the system

• Inspect and clean the column

• Verify the mobile phase composition

• Calibrate and check the detectors

• Troubleshoot software or connectivity issues

• Perform system suitability tests

• Consult instrument manuals or contact technical support if needed

Dissolution test is performed to determine the rate at which a drug substance dissolves in a specified medium.

• Prepare the dissolution medium according to the specified requirements.

• Calibrate the dissolution apparatus by measuring the rotation speed, temperature, and other parameters.

• Place the drug substance in the dissolution vessel and start the test.

• Collect samples at specified time intervals and analyze the amount o...read more

Data integrity is crucial for ensuring accuracy and reliability of data. ALCOA and ALCOA Plus are guidelines for data integrity.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate

• ALCOA Plus adds the principles of Complete, Consistent, Enduring, and Available

• These guidelines ensure that data is recorded accurately, completely, and consistently throughout its lifecycle

• Examples of ALCOA and ALC...read more

UV operation and calibration involves setting up and maintaining the equipment to ensure accurate readings.

• UV equipment must be properly installed and calibrated before use

• Regular maintenance and cleaning is necessary to ensure accurate readings

• Calibration should be performed using a certified reference material

• UV equipment should be regularly checked for accuracy using a calibration curve

• Proper training and documentat

RSD stands for Relative Standard Deviation and is a measure of the variability of a sample compared to its mean.

• RSD is calculated by dividing the standard deviation of a sample by its mean and multiplying by 100.

• It is expressed as a percentage and is often used in analytical chemistry to assess the precision of a method.

• A low RSD indicates that the data is precise and consistent, while a high RSD indicates that the dat...read more

System suitability parameters for HPLC ensure the proper functioning of the system and accuracy of results.

• Retention time of the analyte

• Resolution between peaks

• Theoretical plates

• Peak symmetry factor

• Limit of detection and quantification

• Accuracy and precision of the system

• Mobile phase composition and pH

• Column temperature and pressure

• Flow rate and injection volume

Dissolution is the process by which a solid substance dissolves in a solvent to form a solution.

• The first stage is the wetting stage, where the solid substance comes into contact with the solvent.

• The second stage is the dissolution stage, where the solid substance dissolves in the solvent.

• The third stage is the diffusion stage, where the dissolved substance diffuses away from the solid surface into the bulk of the solv...read more