Syngene International Interview Questions, Process, and Tips

During the development of an analytical method, I faced issues with instrument calibration and sample preparation.

• One issue I encountered was inconsistent instrument calibration, which resulted in inaccurate measurements. To solve this, I thoroughly checked the calibration procedure and recalibrated the instrument as needed.

• Another challenge was optimizing the sample preparation process to ensure reliable and reproduci...read more

All peaks, including known and unknown impurities, should be separated in degradation products method.

• Separating all peaks is important for accurate identification and quantification of impurities.

• Compromising on certain peaks may lead to inaccurate results and potential safety concerns.

• Advanced analytical techniques such as high-resolution mass spectrometry can aid in identifying unknown impurities.

• Proper validation o...read more

During excipient compatibility studies, parameters tested include physical appearance, pH, solubility, melting point, stability, and compatibility with active ingredients.

• Physical appearance of the excipient is observed for any changes or degradation.

• pH of the excipient is measured to ensure it is within the acceptable range.

• Solubility of the excipient in different solvents is tested to determine its compatibility.

• Melt...read more

The increasing impurity peak above the detection limit in excipient compatibility studies suggests a potential issue with the formulation.

• The impurity peak may indicate degradation or reaction of the excipient with the drug product (DP).

• Further investigation is needed to identify the impurity and its source.

• The formulation may need to be modified to prevent or reduce the impurity formation.

• Additional stability studies ...read more

I would investigate the cause of the dissolution failure and propose solutions.

• Conduct dissolution testing to confirm the issue

• Analyze the formulation and manufacturing process for potential issues

• Consider adjusting the formulation or manufacturing process

• Consult with colleagues and experts for additional insights

• Develop a plan for further testing and evaluation

Crystallography has significant impact on finished product and dissolution.

• Crystallography helps determine the structure and arrangement of molecules in a crystal lattice.

• This information is crucial for understanding the physical and chemical properties of the finished product.

• Crystallography can provide insights into the dissolution behavior of a substance.

• By studying crystal structures, scientists can predict how a s...read more