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Question 1

What is the broad definition of Pharmaceutical analysis?

Answer 1

The application of processes to identify a drug (single or combined) in its bulk or pharmaceutical dosage.

Question 2

What are the two types of methods in Pharmaceutical analysis?

Answer 2

• Qualitative methods
• Quantitative methods

Question 3

What is the purpose of qualitative methods in Pharmaceutical analysis?

Answer 3

To ascertain the presence or identification of a component and/or impurities.

Question 4

What do quantitative methods determine in Pharmaceutical analysis?

Answer 4

How much of known drugs are present in bulk form or in a formulation.

Question 5

What is required for methods used in Pharmaceutical analysis?

Answer 5

Validity or control of the method to ensure quality judgment of a drug.

Question 6

List the capabilities required for methods used in Pharmaceutical analysis.

Answer 6

• Correct identification of the drug
• Indicating the percentage of stated content
• Indicating the stability of the drug
• Application in dissolution rate studies
• Ensuring identity and purity of pure drug
• Ensuring identity and purity of excipients
• Indicating concentration of specified impurities

Question 7

What is the significance of stability-indicating methods in Pharmaceutical analysis?

Answer 7

They indicate the presence of a drug in its intact form and any impurities.

Question 8

What does a precise and accurate method in quantitative analysis look like?

Answer 8

Results close to each other and around the mean.

Question 9

How is a precise but inaccurate method characterized?

Answer 9

Results are around each other but far from the mean.

Question 10

Define imprecise and inaccurate methods.

Answer 10

Results are scattered and far away from the mean.

Question 11

What is the formula for Relative Standard Deviation (RSD)?

Answer 11

RSD = (S / X) X 100

Question 12

What do reliable results in quantitative analysis depend on?

Answer 12

Understanding the source of error and knowing when they can be eliminated.

Question 13

What is an error in results?

Answer 13

The difference between the observed answer and the true answer.

Question 14

What are the three types of errors in quantitative analysis?

Answer 14

• Gross errors
• Random errors
• Systematic errors

Question 15

What are gross errors?

Answer 15

Easily recognized errors that lead to unreliable results, often due to contamination or defective instruments.

Question 16

What are systematic errors?

Answer 16

Errors that cause all results to be in error in the same sense, either too low or too high.

Question 17

How are random errors characterized?

Answer 17

The average of results is close to the true value with no evidence of bias.

Question 18

What does repeatability express in terms of precision?

Answer 18

Precision under the same operating conditions over a short interval of time.

Question 19

What does intermediate precision refer to?

Answer 19

Precision that expresses variations within laboratories, such as different days or analysts.

Question 20

What is reproducibility in the context of precision?

Answer 20

Precision between laboratories.

Question 21

Define specificity in Pharmaceutical analysis.

Answer 21

The ability to assess unequivocally the analyte in the presence of expected components.

Question 22

What is the detection limit in analytical procedures?

Answer 22

The lowest amount of analyte in a sample which can be detected but not necessarily quantitated.

Question 23

Fill in the blank: The quantitation limit of an analytical procedure is the lowest amount of analyte that can be ______.

Answer 23

[quantitated as an exact value]

Question 24

What is the detection limit in analytical procedures?

Answer 24

The lowest amount of analyte in a sample that can be detected but not necessarily quantitated as an exact value.

Detection limit is crucial for determining the sensitivity of an analytical method.

Question 25

Define the quantitation limit.

Answer 25

The lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. ## Footnote It is important for ensuring the reliability of quantitative results.

Question 26

What does linearity refer to in an analytical procedure?

Answer 26

The ability to obtain test results that are directly proportional to the concentration of the analyte in the sample within a given range. ## Footnote Linearity is essential for validating the accuracy of analytical methods.

Question 27

What is the range of an analytical procedure?

Answer 27

The interval between the upper and lower limits of an analytical method's applicability. ## Footnote Range determines the scope of a method's use.

Question 28

Define robustness in the context of analytical procedures.

Answer 28

The measure of an analytical procedure's capacity to remain unaffected by small, deliberate variations in method parameters. ## Footnote Robustness indicates reliability during normal usage.

Question 29

What is ruggedness according to the United States Pharmacopeia (USP)?

Answer 29

The degree of reproducibility of test results obtained by analyzing the same samples under varying normal test conditions. ## Footnote Ruggedness assesses the consistency of results across different labs and analysts.

Question 30

How is sensitivity defined in analytical methods?

Answer 30

It is equal to the slope of the calibration line in a linear system. ## Footnote Sensitivity is a crucial characteristic that affects the detection of low concentrations of analytes.

Question 31

Fill in the blank: The method development '______' parallels established approaches to analytical method validation.

Answer 31

life cycle