20+ Emerald Honda Interview Questions and Answers

RS method development for known drug product involves identifying and separating enantiomers.

• Identify the chiral center(s) in the drug molecule

• Choose a suitable chiral stationary phase (CSP) for separation

• Optimize mobile phase composition and flow rate

• Validate the method for accuracy, precision, and specificity

• Consider regulatory requirements for enantiomeric purity

• Examples: RS method development for ibuprofen, omeprazole, etc.

Peak purity is a measure of the homogeneity of a chromatographic peak and is calculated using spectral data.

• Peak purity is determined by comparing the spectral data of the peak at different wavelengths.

• A peak with high purity will have a consistent spectral pattern across all wavelengths.

• Peak purity can be calculated using software or manually by comparing the spectra.

• Peak purity is important in ensuring accurate quantification and identification of compounds in a sample.

• Exam...read more

The biological indicator used in autoclave validation at 115 C is Geobacillus stearothermophilus.

• Geobacillus stearothermophilus is a spore-forming bacterium that is highly resistant to heat and is commonly used as a biological indicator in autoclave validation.

• It is used to ensure that the autoclave is effectively sterilizing equipment and materials at the desired temperature and pressure.

• Other biological indicators, such as Bacillus atrophaeus, may be used for different temp...read more

Water content mechanism can be found through various methods and is important for various reasons.

• Water content can be measured through techniques such as gravimetric analysis, Karl Fischer titration, and moisture analyzers.

• Water content is important in industries such as food, pharmaceuticals, and cosmetics to ensure product quality and stability.

• Water content is also important in environmental studies to understand the water cycle and its impact on ecosystems.

• In the human b...read more

There are several types of columns in HPLC, including C18, C8, phenyl, and more. Column selection depends on the analyte and separation goal.

• Common types of HPLC columns include C18, C8, phenyl, and more

• Column selection depends on the analyte and separation goal

• C18 columns are commonly used for hydrophobic compounds

• Phenyl columns are useful for separating aromatic compounds

• C8 columns are a good alternative to C18 for some applications

• Other factors to consider when selecting a...read more

System suitability criteria for RS and Assay method

• RS: resolution between critical pairs should be greater than 1.5

• Assay: accuracy, precision, linearity, range, specificity, LOD, LOQ

• Acceptance criteria should be predefined and met

• System suitability test should be performed before sample analysis

The three media used in microbiology analysis without sterilization are selective media, differential media, and enrichment media.

• Selective media: These media contain specific nutrients or chemicals that inhibit the growth of certain microorganisms while allowing the growth of others. For example, MacConkey agar is a selective medium used to isolate and differentiate Gram-negative bacteria.

• Differential media: These media contain indicators that allow the differentiation of di...read more

Caffeine is used in HPLC calibration tests to determine the accuracy and precision of the instrument.

• Caffeine is a common standard used in HPLC calibration tests because it is readily available, stable, and has a well-defined retention time.

• The tests involve injecting a known amount of caffeine into the HPLC system and measuring its retention time and peak area.

• The results are compared to established reference values to ensure the accuracy and precision of the instrument.

• Othe...read more

Calibration tests for dissolution involve using prednisone as a standard.

• Prednisone is used as a standard because it is a commonly used drug and has a known dissolution rate.

• Calibration tests ensure that the dissolution apparatus is functioning properly and producing accurate results.

• Tests may include checking the temperature, pH, and agitation rate of the dissolution medium.

• The results of calibration tests are used to adjust the apparatus and ensure that it meets regulatory ...read more

Discrimination media in dissolution refers to the selective dissolution of certain components in a mixture.

• It occurs when certain components dissolve faster or slower than others due to differences in solubility or chemical properties.

• Examples include the dissolution of sugar in water, where sugar dissolves faster than other components like sand or salt.

• In pharmaceuticals, discrimination media can be used to test the dissolution rate of different drug formulations.

• It is impor...read more

E.coli colony found red brick on Macconkey agar plates due to lactose fermentation.

• E.coli is a lactose fermenting bacteria

• Macconkey agar is a selective and differential media used to isolate and differentiate lactose fermenting bacteria

• Lactose fermentation produces acid which lowers the pH of the agar and changes the color of the indicator from yellow to red

• E.coli colonies appear as red brick on Macconkey agar plates

Developing HPLC methods involves selecting appropriate columns and optimizing parameters.

• Choose a suitable column based on the analyte's properties and the separation goal.

• Optimize parameters such as mobile phase composition, flow rate, and temperature.

• Validate the method by assessing its selectivity, sensitivity, accuracy, and precision.

• Common column types include C18, C8, and phenyl.

• Other factors to consider include column dimensions, particle size, and pore size.

• HPLC metho...read more

The limit for unknown impurity is decided based on the safety and efficacy of the drug.

• The limit should be set below the level that may cause harm to patients.

• The limit should be based on the analytical method used to detect the impurity.

• The limit should be reviewed periodically and updated if necessary.

• The limit should be justified and documented in the drug's regulatory submission.

• For example, if the impurity is a known carcinogen, the limit should be set as low as reasonab...read more

Linearity and accuracy are important measures in remote sensing. Linearity refers to the relationship between input and output values, while accuracy refers to the closeness of measured values to true values.

• Linearity measures the consistency of the relationship between input and output values

• Accuracy measures the closeness of measured values to true values

• Linearity and accuracy are important for ensuring reliable and consistent remote sensing data

• Examples of factors that can...read more

Carbon loading in column refers to the amount of carbon used in the stationary phase of a chromatography column. Endcapping is a process to block the remaining silanol groups on the surface of the stationary phase.

• Carbon loading is typically expressed as a percentage of the total weight of the stationary phase.

• Higher carbon loading can improve the selectivity and retention of certain analytes.

• Endcapping is important to prevent unwanted interactions between the analytes and th...read more

Specificity can be performed by measuring the ability of a test to correctly identify those without the condition.

• Specificity is a statistical measure that evaluates the accuracy of a test.

• It is calculated by dividing the number of true negatives by the sum of true negatives and false positives.

• A high specificity indicates that the test is good at identifying those without the condition.

• For example, a test for a rare disease may have a high specificity but a low sensitivity, ...read more

Developing a method for dissolution involves determining the appropriate conditions and parameters for the dissolution of a substance.

• Identify the substance to be dissolved and its properties

• Select a suitable solvent for the dissolution process

• Establish the dissolution conditions such as temperature, agitation, and time

• Validate the method through testing and analysis

• Optimize the method for efficiency and accuracy

Developing a method on HPLC involves understanding the sample, selecting appropriate columns and mobile phases, optimizing parameters, and validating the method.

• Understand the sample composition and properties

• Select appropriate columns based on sample characteristics

• Choose suitable mobile phases for separation

• Optimize parameters such as flow rate, temperature, and gradient elution

• Validate the method by testing for specificity, linearity, accuracy, and precision

RI detector measures the refractive index of a sample to detect its presence and concentration.

• RI detector works by measuring the change in the angle of light as it passes through a sample with a different refractive index.

• The detector can be used in various industries such as pharmaceuticals, food and beverage, and environmental monitoring.

• RI detector is commonly used in high-performance liquid chromatography (HPLC) to detect and quantify analytes in a sample.

• The principle o...read more

Detectors are selected based on factors such as sensitivity, specificity, cost, ease of use, and intended application.

• Consider the sensitivity of the detector to ensure accurate detection of the target analyte.

• Evaluate the specificity of the detector to minimize false positive results.

• Take into account the cost of the detector and compare it with the budget constraints.

• Assess the ease of use of the detector to ensure efficient operation and minimal training requirements.

• Choos...read more