10+ Ipca Laboratories Senior Research Associate Interview Questions and Answers

LOQ stands for Limit of Quantitation as per ICH guidelines. It is the lowest concentration of an analyte that can be reliably measured.

• LOQ is determined by analyzing a series of samples with known concentrations of the analyte and calculating the standard deviation and slope of the calibration curve.

• The LOQ is typically defined as the concentration at which the signal-to-noise ratio is at least 10:1.

• It is important to establish the LOQ for a method to ensure accurate and prec...read more

Specificity in assay method refers to the ability of the method to accurately measure only the target analyte without interference from other substances.

• Specificity is determined by testing the method with known standards and samples containing the target analyte as well as potential interfering substances.

• Cross-reactivity with similar compounds should be evaluated to ensure the method is specific to the target analyte.

• Selectivity is another term used interchangeably with spe...read more

The question asks for a reaction and prediction of H1 NMR under different conditions.

• Provide a detailed reaction involving a compound and reagent

• Discuss the possible H1 NMR shifts based on the reaction conditions

• Consider variations in temperature, solvent, and concentration for different predictions

Degradation studies are essential to understand the stability and shelf-life of pharmaceutical products.

• To determine the degradation pathways of a drug substance or product

• To establish the shelf-life of a pharmaceutical product

• To ensure the safety and efficacy of the product over time

• To comply with regulatory requirements

• To optimize storage conditions for the product

• Examples: conducting stress testing, accelerated stability studies, photostability testing

Chemical reactions involve the breaking and forming of chemical bonds to create new substances with different properties.

• Chemical reactions involve the rearrangement of atoms to form new substances

• Reactants are the starting materials and products are the end result of a chemical reaction

• Chemical reactions can be classified as exothermic or endothermic based on energy changes

• Catalysts can speed up chemical reactions without being consumed in the process

Solvent classes include polar, nonpolar, protic, aprotic, and supercritical fluids.

• Polar solvents dissolve polar compounds and have a dipole moment.

• Nonpolar solvents dissolve nonpolar compounds and lack a dipole moment.

• Protic solvents have a hydrogen atom attached to an electronegative atom and can donate hydrogen bonds.

• Aprotic solvents lack a hydrogen atom attached to an electronegative atom and cannot donate hydrogen bonds.

• Supercritical fluids have properties of both a gas ...read more

Solubility studies are conducted to determine the ability of a substance to dissolve in a particular solvent.

• Solubility studies involve testing the solubility of a substance in different solvents.

• Various methods such as shake flask method, equilibrium solubility method, and kinetic solubility method can be used.

• Factors affecting solubility include temperature, pH, and particle size.

• Analytical techniques like UV-Vis spectroscopy, HPLC, and LC-MS can be used to analyze solubili...read more

Mechanical calibration of Dissolution Apparatus involves ensuring the apparatus is functioning accurately and consistently.

• Calibration involves checking the alignment of the shaft, speed of rotation, temperature control, and vessel centering.

• Regular calibration is necessary to ensure accurate and reliable dissolution testing results.

• Examples of calibration methods include using standard weights for balance calibration and checking the rotation speed with a tachometer.

• Calibrat...read more

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