ccc Flashcards
What is the broad definition of Pharmaceutical analysis?
The application of processes to identify a drug (single or combined) in its bulk or pharmaceutical dosage.
What are the two types of methods in Pharmaceutical analysis?
- Qualitative methods
- Quantitative methods
What is the purpose of qualitative methods in Pharmaceutical analysis?
To ascertain the presence or identification of a component and/or impurities.
What do quantitative methods determine in Pharmaceutical analysis?
How much of known drugs are present in bulk form or in a formulation.
What is required for methods used in Pharmaceutical analysis?
Validity or control of the method to ensure quality judgment of a drug.
List the capabilities required for methods used in Pharmaceutical analysis.
- 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
What is the significance of stability-indicating methods in Pharmaceutical analysis?
They indicate the presence of a drug in its intact form and any impurities.
What does a precise and accurate method in quantitative analysis look like?
Results close to each other and around the mean.
How is a precise but inaccurate method characterized?
Results are around each other but far from the mean.
Define imprecise and inaccurate methods.
Results are scattered and far away from the mean.
What is the formula for Relative Standard Deviation (RSD)?
RSD = (S / X) X 100
What do reliable results in quantitative analysis depend on?
Understanding the source of error and knowing when they can be eliminated.
What is an error in results?
The difference between the observed answer and the true answer.
What are the three types of errors in quantitative analysis?
- Gross errors
- Random errors
- Systematic errors
What are gross errors?
Easily recognized errors that lead to unreliable results, often due to contamination or defective instruments.
What are systematic errors?
Errors that cause all results to be in error in the same sense, either too low or too high.
How are random errors characterized?
The average of results is close to the true value with no evidence of bias.
What does repeatability express in terms of precision?
Precision under the same operating conditions over a short interval of time.
What does intermediate precision refer to?
Precision that expresses variations within laboratories, such as different days or analysts.
What is reproducibility in the context of precision?
Precision between laboratories.
Define specificity in Pharmaceutical analysis.
The ability to assess unequivocally the analyte in the presence of expected components.
What is the detection limit in analytical procedures?
The lowest amount of analyte in a sample which can be detected but not necessarily quantitated.
Fill in the blank: The quantitation limit of an analytical procedure is the lowest amount of analyte that can be ______.
[quantitated as an exact value]
What is the detection limit in analytical procedures?
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.
Define the quantitation limit.
The lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy.
It is important for ensuring the reliability of quantitative results.
What does linearity refer to in an analytical procedure?
The ability to obtain test results that are directly proportional to the concentration of the analyte in the sample within a given range.
Linearity is essential for validating the accuracy of analytical methods.
What is the range of an analytical procedure?
The interval between the upper and lower limits of an analytical method’s applicability.
Range determines the scope of a method’s use.
Define robustness in the context of analytical procedures.
The measure of an analytical procedure’s capacity to remain unaffected by small, deliberate variations in method parameters.
Robustness indicates reliability during normal usage.
What is ruggedness according to the United States Pharmacopeia (USP)?
The degree of reproducibility of test results obtained by analyzing the same samples under varying normal test conditions.
Ruggedness assesses the consistency of results across different labs and analysts.
How is sensitivity defined in analytical methods?
It is equal to the slope of the calibration line in a linear system.
Sensitivity is a crucial characteristic that affects the detection of low concentrations of analytes.
Fill in the blank: The method development ‘______’ parallels established approaches to analytical method validation.
life cycle
