PH-PSC 221 Pharmaceutical Analysis 2: Instrumental Methods of Analysis

Flashcards for reviewing key concepts in pharmaceutical analysis, focusing on statistical quality control methods and molecular absorption spectrophotometry.

What is Dixon’s Q-test used for in pharmaceutical analysis?

It is used to identify and statistically justify the rejection of outliers in a given dataset.

Define 'Outlier' in the context of statistical quality control.

An observation that is generated from a different model or a different distribution than the main body of data.

It allows us to examine if one (and only one) observation from a small

set of replicate observations (typically 3 to 10) can be "legitimately”

rejected or n

What are 3-Sigma Control Limits used for in quality control?

They are used to determine if a process is in a state of statistical control by examining the variation over time.

How are the upper and lower limits of a 3-Sigma control chart calculated?

Upper Limit = ar{x} + 3 imes ext{s}; Lower Limit = ar{x} - 3 imes ext{s}.

What does a control chart indicate when all plotted points fall within the control limits?

It indicates that the experiments or processes are statistically controlled.

What is the purpose of acceptance sampling in manufacturing?

To evaluate quality by examining randomly selected samples instead of 100% inspection.

Identify a key advantage of using statistical sampling instead of 100% inspection.

Statistical sampling can provide better quality assurance than 100% inspection while being less expensive and less fatiguing.

What is the role of the Operating Characteristic (OC) Curve in sampling plans?

It illustrates the performance of a sampling plan by showing the relationship between the percentage of defectives and the probability of acceptance.

List one factor affecting the stability of pharmaceutical products.

Interaction between active ingredients and excipients.

Define 'Expiration Date' in the context of stability testing.

The time up to which the product will remain stable when stored under recommended storage conditions.

What is included in the definition of stability testing?

It evaluates the effect of environmental factors on the quality of the drug substance or formulated product.

What is the significance of the Beer-Lambert Law in UV/Vis spectrophotometry?

It describes the exponential decrease in transmitted light power as the concentration of absorbing species increases.

How is absorbance related to transmittance?

Absorbance is logarithmically related to transmittance; specifically, it is the logarithm of the inverse of transmittance.

What analysis can be performed using UV/Vis spectrophotometry in pharmaceutical analysis?

Quantitative chemical analysis.

What is the primary application of infrared (IR) spectrometry?

To measure the absorption of radiant energy that corresponds to vibrational transitions of atoms within molecules.

For IR spectroscopy, what is necessary for a molecule to absorb IR radiation?

It must undergo a net change in dipole moment due to vibrational and rotational motion.

Name one sample preparation method used in IR spectroscopy.

KBr pellets or liquid cells.

Why is the Arrhenius equation important in stability testing?

It relates degradation rates at different temperatures, allowing predictions of product stability.

Define the term chromophore in the context of UV/Vis spectroscopy.

A functional group or bond within a molecule that is capable of absorbing UV/Vis radiation.

Describe the relationship between the wavelength and energy of electromagnetic radiation.

Energy is inversely related to wavelength; as wavelength increases, energy decreases.

What is the principle of spectroscopy that relates to the absorption of radiation by molecules?

Molecules absorb radiation at specific wavelengths corresponding to electronic transitions.