QC II LEC - Post-Discussion Quiz (1-3)

A set of stringent written guidelines required for regulatory acceptance

A protocol in analytical methodology is best defined as:

0.001 g to 0.01 g

Microanalysis involves analysis of samples within which mass range?

Assay

In pharmaceutical analysis, the quantitative estimation of the major constituent of a drug product is called:

Based on nature of analytical method

Which classification of analytical methods is based on the physical parameter measured (e.g., weight, volume, radiation intensity)?

Fundamental analysis

Which branch of analytical chemistry focuses on improving existing analytical methods or developing new ones?

What is it? and How much is it?

Analytical chemistry is primarily concerned with answering which two fundamental questions about a sample?

Qualitative analysis

Which branch of analytical chemistry deals with determining the chemical identity of substances present in a sample?

Gravimetry

Which of the following is considered a classical (total analysis) technique?

Optical or electrical signals proportional to analyte concentration

Instrumental (concentration) techniques generally measure:

Sampling

In the general analytical process, which step ensures that the collected portion truly represents the material being analyzed?

Matrix effects cannot be ignored

The standard addition method is most useful when:

Have a fixed concentration in all samples and standards

In the internal standard method, the internal standard must:

Prepared and analyzed separately from the sample

In an external standard method, the standards are:

A solution prepared without the analyte

A reagent blank is best described as:

Reduces uncertainty and verifies linearity

A multiple-point standardization is preferred over a single-point standardization because it:

Determining the relationship between analytical signal and analyte

Standardization of an analytical method refers to:

The measured signal is free from determinate error

Calibration of an instrument primarily ensures that:

Accounts for both matrix and analyte interactions

The total Youden blank is considered the true blank because it:

Matrix effects

A proportional determinate error in external standardization commonly arises from:

It uses one standard and carries all experimental errors

Which statement best describes single-point standardization?

Intermediate precision

Which level of precision evaluates variations within the same laboratory such as different days, analysts, or equipment?

Specificity

Which validation parameter refers to the ability to asses unequivocally the analyte in the presence of impurities, degradants, or matrix components?

Accuracy

Which validation characteristic expresses the closeness of agreement between the accepted true value and the value found?

Capacity to remain unaffected by small deliberate variations in method parameters

Robustness of an analytical procedure refers to its:

The lowest amount of analyte that can be detected but not necessarily quantified

The limit of detection (LOD) is best described as:

Demonstration that an analytical procedure is suitable for its intended purpose

Analytical method validation is best defined as:

Assessment of suitability under actual conditions of use

Verification of a compendial procedure involves:

Correlation coefficient

Which of the following is NOT a measure of precision?

80% to 120% of the test concentration

For the assay of a finished product, the typical validated range is normally:

10:1

A typical signal-to-noise ratio used for estimating the limit of quantitation (LOQ) is: