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Questions and Answers
Questions and Answers
In analytical chemistry, what is the primary goal of the 'analysis' process as defined in the provided context?
In analytical chemistry, what is the primary goal of the 'analysis' process as defined in the provided context?
- To determine the composition and understand the nature of materials or medicinal substances. (correct)
- To synthesize new chemical compounds with novel properties.
- To improve company profits by creating more cost-effective analytical techniques.
- To develop new methods for regulatory compliance in pharmaceutical manufacturing.
Why is the sampling step crucial in the analytical process for pharmaceutical analysis, according to the provided text?
Why is the sampling step crucial in the analytical process for pharmaceutical analysis, according to the provided text?
- To simplify the analytical procedure by focusing on a smaller, more manageable subset.
- To minimize the cost of conducting the analysis by reducing the required sample volume.
- To comply with marketing regulations requiring representative samples for advertising purposes.
- To ensure the sample chosen accurately represents the entire batch from which it was taken. (correct)
In analytical method validation, what is the primary significance of specificity?
In analytical method validation, what is the primary significance of specificity?
- To verify that the method is precise and yields consistent results over time.
- To ensure that the method is cost-effective and can be performed rapidly.
- To demonstrate that the method can accurately measure the analyte without interference from other components. (correct)
- To confirm the method's compliance with regulatory standards and legal requirements.
Why are Standard Operating Procedures (SOPs) essential in pharmaceutical sampling?
Why are Standard Operating Procedures (SOPs) essential in pharmaceutical sampling?
What is the purpose of performing replicate measurements of the same sample in quantitative analysis?
What is the purpose of performing replicate measurements of the same sample in quantitative analysis?
How are gross errors typically managed in analytical procedures?
How are gross errors typically managed in analytical procedures?
What does 'precision' indicate in the context of analytical measurements?
What does 'precision' indicate in the context of analytical measurements?
What is the purpose of calculating the relative standard deviation (%RSD) in analytical chemistry?
What is the purpose of calculating the relative standard deviation (%RSD) in analytical chemistry?
What is 'repeatability' in the context of analytical assays?
What is 'repeatability' in the context of analytical assays?
Why is it important to distinguish between repeatability and within-assay precision?
Why is it important to distinguish between repeatability and within-assay precision?
What is the purpose of an analytical blank in analytical procedures control?
What is the purpose of an analytical blank in analytical procedures control?
According to the provided text, what is the Limit of Detection?
According to the provided text, what is the Limit of Detection?
According to the provided text, what is 'Linearity'?
According to the provided text, what is 'Linearity'?
What does the term 'Robustness' refer to in analytical method validation?
What does the term 'Robustness' refer to in analytical method validation?
Why is the extraction step of samples important prior to analysis?
Why is the extraction step of samples important prior to analysis?
What is the main purpose of solvent extraction?
What is the main purpose of solvent extraction?
What is the function of the Solid Phase Extraction (SPE)?
What is the function of the Solid Phase Extraction (SPE)?
What is Chromatography, based on the provided text?
What is Chromatography, based on the provided text?
In volumetric analysis, why identifying functional groups on the molecule is important?
In volumetric analysis, why identifying functional groups on the molecule is important?
What does the British Pharmacopoeia offer, in addition to purity specifications, for drug substances?
What does the British Pharmacopoeia offer, in addition to purity specifications, for drug substances?
Why is it important to perform assays at least in duplicate in volumetric analysis?
Why is it important to perform assays at least in duplicate in volumetric analysis?
What determines the endpoint of a titration when using an indicator?
What determines the endpoint of a titration when using an indicator?
What is the purpose of conducting a blank titration?
What is the purpose of conducting a blank titration?
Why are non-aqueous titrations used in pharmaceutical analysis?
Why are non-aqueous titrations used in pharmaceutical analysis?
In titrations, balancing redox reactions requires accounting for:
In titrations, balancing redox reactions requires accounting for:
Karl Fischer titration is primarily used for what purpose in pharmaceutical analysis?
Karl Fischer titration is primarily used for what purpose in pharmaceutical analysis?
In capillary electrophoresis, what is the purpose of applying an electric field?
In capillary electrophoresis, what is the purpose of applying an electric field?
According to the provided text, what is the EOF?
According to the provided text, what is the EOF?
In refractometry, what property of a substance is directly related to the refractive index?
In refractometry, what property of a substance is directly related to the refractive index?
In the context of most organic liquids, how does temperature affect the refractive index?
In the context of most organic liquids, how does temperature affect the refractive index?
What does polarimetry measure?
What does polarimetry measure?
What does 'enantiomeric excess' reflect?
What does 'enantiomeric excess' reflect?
What type of light is typically required for electronic transition?
What type of light is typically required for electronic transition?
In UV/Vis spectroscopy, what is a chromophore?
In UV/Vis spectroscopy, what is a chromophore?
What is a bathochromic shift?
What is a bathochromic shift?
What is the role of a monochromator in a spectrophotometer?
What is the role of a monochromator in a spectrophotometer?
What does Beer's law state regarding the relationship between light intensity and concentration of absorbing molecules?
What does Beer's law state regarding the relationship between light intensity and concentration of absorbing molecules?
In spectroscopic terms, what does 'A 1%, 1 cm' refer to?
In spectroscopic terms, what does 'A 1%, 1 cm' refer to?
What is not in UV?
What is not in UV?
In fluorescence spectroscopy, why are measurements best made on solutions with low absorbance?
In fluorescence spectroscopy, why are measurements best made on solutions with low absorbance?
What characteristics are molecules associated with in order to exhibit fluorescence?
What characteristics are molecules associated with in order to exhibit fluorescence?
In pharmaceutical analysis, how does method validation contribute to ensuring drug product quality?
In pharmaceutical analysis, how does method validation contribute to ensuring drug product quality?
How does sample preparation impact the reliability of analytical results in pharmaceutical analysis?
How does sample preparation impact the reliability of analytical results in pharmaceutical analysis?
During volumetric analysis, what is the significance of using duplicate titrations?
During volumetric analysis, what is the significance of using duplicate titrations?
If a scientist is performing capillary electrophoresis, what does an increase in applied voltage achieve?
If a scientist is performing capillary electrophoresis, what does an increase in applied voltage achieve?
How does temperature control during refractometry measurements affect the accuracy of results?
How does temperature control during refractometry measurements affect the accuracy of results?
An enantiomeric excess (ee) determination of 0% indicates what about the chiral sample?
An enantiomeric excess (ee) determination of 0% indicates what about the chiral sample?
In UV/Vis spectroscopy, why must ultraviolet (UV) or visible light be used for electronic transitions?
In UV/Vis spectroscopy, why must ultraviolet (UV) or visible light be used for electronic transitions?
In quantitative UV/Vis spectrophotometry, what parameters does Beer-Lambert law relate?
In quantitative UV/Vis spectrophotometry, what parameters does Beer-Lambert law relate?
In UV/Vis Spectroscopy which of the following statements about a bathochromic shift is correct?
In UV/Vis Spectroscopy which of the following statements about a bathochromic shift is correct?
Why should absorbance in fluorescence spectroscopy be considered when generating solutions?
Why should absorbance in fluorescence spectroscopy be considered when generating solutions?
Which situation exemplifies good manufacturing practice during pharmaceutical analysis?
Which situation exemplifies good manufacturing practice during pharmaceutical analysis?
During sample preparation, why is it important to remove insoluble tablet matrices or oily excipients?
During sample preparation, why is it important to remove insoluble tablet matrices or oily excipients?
In solvent extraction, what role does adjusting the pH play for separating compounds?
In solvent extraction, what role does adjusting the pH play for separating compounds?
How does the 'cleanup mode' function when chromatography is used as a sample preparation technique?
How does the 'cleanup mode' function when chromatography is used as a sample preparation technique?
When designing a volumetric assay, why does one determine what functional groups that react?
When designing a volumetric assay, why does one determine what functional groups that react?
What information does the British Pharmacopoeia provide concerning the assay of a drug?
What information does the British Pharmacopoeia provide concerning the assay of a drug?
When carrying out back titrations, what is the purpose of also conducting a blank titration?
When carrying out back titrations, what is the purpose of also conducting a blank titration?
Why conduct non-aqueous titrations for weakly acidic or basic drugs?
Why conduct non-aqueous titrations for weakly acidic or basic drugs?
How must one balance Redox Titration differently than others?
How must one balance Redox Titration differently than others?
What’s the Karl Fischer titration to find about a compound?
What’s the Karl Fischer titration to find about a compound?
Within the process of Capillary Electrophoresis what part does charge play?
Within the process of Capillary Electrophoresis what part does charge play?
While doing measurements during Refractometry, what determines how accurate it will be?
While doing measurements during Refractometry, what determines how accurate it will be?
How must polarized light be lined up when interacting with optically active/chiral substance?
How must polarized light be lined up when interacting with optically active/chiral substance?
For spectroscopic-related tests to be used well, what does the light need?
For spectroscopic-related tests to be used well, what does the light need?
Why must quantitative work always involve a pie (*) electron system?
Why must quantitative work always involve a pie (*) electron system?
When attempting to determine something is a known or unknown, what factor is helpful?
When attempting to determine something is a known or unknown, what factor is helpful?
What usually causes a bathochromic shift to occur to the Auxochrome?
What usually causes a bathochromic shift to occur to the Auxochrome?
If attempting to do Florescence intensity, what part of measurement is important?
If attempting to do Florescence intensity, what part of measurement is important?
Of the tests described, which one doesn't require some level of UV radiation/Spectroscopy?
Of the tests described, which one doesn't require some level of UV radiation/Spectroscopy?
Questions and Answers
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Flashcards
Flashcards
Analysis as a process
Analysis as a process
The process of separating or breaking down a whole system into its parts to understand its nature and determine composition.
Definition of analytical problem
Definition of analytical problem
The initial step in total analysis, where the problem or question to be solved is clearly defined.
Gross Errors
Gross Errors
Gross errors are major breakdowns in the analytical process, like spilling samples or using instruments incorrectly, leading to rejection of results.
Assay Precision
Assay Precision
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Repeatability
Repeatability
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Reproducibility
Reproducibility
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Random Error (Glassware)
Random Error (Glassware)
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Analytical Blank
Analytical Blank
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Calibration
Calibration
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Limit of Detection (LOD)
Limit of Detection (LOD)
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Linearity (Analytical Method)
Linearity (Analytical Method)
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Weighing by difference
Weighing by difference
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Impurities (starting materials)
Impurities (starting materials)
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Impurities (intermediates/by-products)
Impurities (intermediates/by-products)
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Impurities (reagents/solvents)
Impurities (reagents/solvents)
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Impurities (manufacturing environment)
Impurities (manufacturing environment)
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Impurities (excipients)
Impurities (excipients)
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Cross-contamination
Cross-contamination
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Microbial contamination
Microbial contamination
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Impurities (drug-excipient reaction)
Impurities (drug-excipient reaction)
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Impurities from packaging
Impurities from packaging
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Purpose of Extraction
Purpose of Extraction
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Centrifugation (Extraction)
Centrifugation (Extraction)
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Solvent Extraction
Solvent Extraction
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Solid Phase Extraction (SPE)
Solid Phase Extraction (SPE)
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Ultrafiltration
Ultrafiltration
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Chromatography
Chromatography
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Chromatography (Clean-up Mode)
Chromatography (Clean-up Mode)
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Chromatography (Analytical Mode)
Chromatography (Analytical Mode)
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Immunoassay
Immunoassay
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Volumetric Analysis
Volumetric Analysis
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Volumetric Glassware
Volumetric Glassware
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Quantitative Reaction (Volumetric)
Quantitative Reaction (Volumetric)
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Stoichiometric Ratio
Stoichiometric Ratio
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Equivalent Relationship
Equivalent Relationship
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British Pharmacopoeia (BP)
British Pharmacopoeia (BP)
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BP Monograph
BP Monograph
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Limit Tests (BP)
Limit Tests (BP)
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Titration Indicators
Titration Indicators
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Back Titration
Back Titration
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Blank Titration
Blank Titration
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Non-aqueous Titrations
Non-aqueous Titrations
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REDOX Titrations
REDOX Titrations
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Compleximetric Titrations
Compleximetric Titrations
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Karl Fischer Titration
Karl Fischer Titration
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Capillary Electrophoresis (CE)
Capillary Electrophoresis (CE)
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Electrophoretic Mobility
Electrophoretic Mobility
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Electroosmotic Flow (EOF)
Electroosmotic Flow (EOF)
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Analytical Spectroscopy
Analytical Spectroscopy
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Visible Spectrum
Visible Spectrum
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Wavelength (λ)
Wavelength (λ)
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Energy-Wavelength Relationship
Energy-Wavelength Relationship
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Chromophore
Chromophore
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Auxochrome
Auxochrome
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Bathochromic Effect
Bathochromic Effect
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Hypsochromic Effect
Hypsochromic Effect
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Hyperchromic Effect
Hyperchromic Effect
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Hypochromic Effect
Hypochromic Effect
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Spectrophotometer
Spectrophotometer
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Spectrophotometer Light Source
Spectrophotometer Light Source
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Monochromator
Monochromator
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Photomultiplier Tube
Photomultiplier Tube
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Beer's Law
Beer's Law
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Lambert's Law
Lambert's Law
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Beer-Lambert Law
Beer-Lambert Law
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Refractive Index (n)
Refractive Index (n)
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Polarimetry
Polarimetry
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Plane-polarized Light
Plane-polarized Light
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Angle of Rotation (Optical Rotation)
Angle of Rotation (Optical Rotation)
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Enantiomeric Excess (ee)
Enantiomeric Excess (ee)
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Specific Rotation ([α])
Specific Rotation ([α])
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Fluorescence Spectrophotometry
Fluorescence Spectrophotometry
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Fluorescence Energy Shift
Fluorescence Energy Shift
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Scatter in Fluorescence
Scatter in Fluorescence
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Raman Scatter
Raman Scatter
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Robustness (Assay)
Robustness (Assay)
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Selectivity (Analytical Method)
Selectivity (Analytical Method)
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Sensitivity (Analytical Method)
Sensitivity (Analytical Method)
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Study Notes
Study Notes
PHRM 353 Topics
- The learning material covers a range of topics relevant to pharmaceutical analysis
- These topics included analytical techniques, instrumentation, and quality control methods
Pharmaceutical Instrumentation Knowledge
- It is imperative pharmacists possess thorough knowledge of instrumentation and methods for pharmaceutical analysis
- Development of pharmaceuticals has brought about a revolution in human health
- Pharmaceuticals can only serve their intended purpose if they are free from impurities
- They also need to be administered in the correct amount
- Various chemical and instrumental methods were developed to estimate the drugs to ensure drugs are safe to use
- Pharmaceuticals develop impurities at various stages like development, transportation and storage making them risky
- Analytical instrumentation and methods play a vital role in identifying and quantifying these impurities
Analysis as a Process
- Analysis involves separating or breaking down a whole system to understand its components
- The analytical process aids pharmaceutical chemists in determining composition and understanding materials
- The total analysis process has six steps
- Defining the analytical problem
- Sampling to obtain a representative sample
- Choosing an appropriate analytical method
- Separating the analyte from interfering substances
- Performing a quantitative measurement (quantitation)
- Evaluating the analytical data
Analysis Process Needs
- Analysis is frequently required to meet regulatory standards
- Analysis is frequently required to produce evidence for potential litigation
- Analysis is frequently required to help improve company profits
- Analysis is frequently required to determine new chemical reaction products
- Analysis is frequently required to satisfy customer needs
Sampling Procedures
- Pharmaceutical industry uses strict Standard Operating Procedures (SOPs) for sampling
- SOPs ensure uniformity and consistency in the sampling process
- SOP's detail key aspects of sampling
- Method
- Equipment
- Sample amount
- Subdivision instructions
- Container details
- Labeling
- Precautions,
- Equipment cleaning and storage
Method Selection Considerations
- Analytical chemists need to be familiar with available methods to choose an appropriate one
- The following factors need to be considered
- Accuracy
- Detection limit
- Selectivity
- Speed
- Cost
- Legality
Pharmacopoeial Specifications
- Official monographs in pharmacopoeias (BP, USP, EP) describe specifications and tests for non-active substances
- If non-pharmacopoeial methods are used, they must be validated against official methods
- All test methods in the pharmaceutical industry must be written, approved, and detailed for raw materials/intermediates
- Results need to be recorded with approved documentation
Analytical Process Checks
- After performing an analytical process, it is essential to confirm both process validity and material compliance
Accurate Record Keeping
- Keeping accurate analysis records is necessary
- Records provide evidence in potential court cases
- Analysis is important for process control
Critical Communication Step
- Reducing data to a transmittable and efficiently assimilated amount is a critical step in communicating scientific results
Methodology
- Analyses are often repeated on the same sample to enhance conciseness and improve clarity of reported results
Method Validation
- Validation is a primary concern in research and development for handling data and processes effectively
Regulatory Validation
- Regulatory bodies worldwide eg MCC, FDA, and EC enforce method validation before accepting an assay method
- Increased scrutiny of analytical validation documentation is now present
Method Validation Necessity
- Method validation is required for
- Developmental pharmaceutics
- In-process quality control
- Testing starting materials (especially active ones)
- Intermediate product testing
- Finished product testing
- Stability testing
- Method transfers
- Manufacturing changes
- Composition alterations
Tests for Validation
- Analytical methods validation is expected for
- ID tests specificity
- Related substances tests (specificity, detection limit, and quantitation limit)
- Assay (specificity, repeatability, reproducibility, accuracy, precision, linearity, range, and sensitivity)
Validation Report Key Details
- A validation report should contain
- Test procedure principles description
- Detailed actual method procedures (including precautions)
- Exact test conditions like reagents and reference materials
- Verification of the test procedure
- Calculation formulas for results and statistical routines
- Equipment details
Quality Control
- Validation ensures quality, safety, and efficacy
Pharmaceutical Analysis Questions
- Pharmaceutical analysis methods are used to clarify
- Drug identity in formulations
- Stated content percentages of a drug
- Impurities present
- Drug stability and product shelf life
- Drug release rates from the formulation
- Purity of drug substances for formulation
- Concentrations of impurities and drugs in tissues or fluids
- Physicochemical properties such as pKa values, partition coefficients, solubility, and stability
Error Consideration
- Quantitative analysis requires some estimation of error
- Accepting results without assessing error potential could lead to faulty product decisions
- Multiple sample measurements help determine the agreement level between them
Error Types
- Three types of errors can occur
- Gross errors
- Systematic errors
- Random errors
- Easily spotted gross errors involve major analytical breakdowns and require restarts
- Random and systematic errors need specific distinction methods
Precision
- High precision means all measurements are close, indicating good control
Accuracy
- High accuracy means the mean of measurements is close to the true value
Analytical Results
- Analytical results must be accurate and percise
Gaussian Pattern
- Series of measurements of the same sample will be normally distributed around a mean
- The goal to reduce the standard deviation as a percentage of the mean
Confidence Limits
- Confidence limits are often not quoted
- Since the SD, is an estimate of (σ), the confidence limits are usually 68%
Precision Expression Advantages
- Expressing precision as a percentage eliminates units and is easy to interpret
Repeatability and Reproducibility
- Repeatability and reproducibility ensure an assay's validity across occasions
- These terms need precise definitions to avoid redundancy, focusing on assay precision
Precision Definition
- Precision is the measure of an assay's ability to deliver close agreement among multiple determinations of the same sample
- It is fairly general because the assay is described and the extent of the details given precision may vary
- It should be termed 'within-assay precision'
Repeatability
- Repeatability includes all operations carried out in an assay of a particular sample from the beginning
- Carried out by a single operator
- In sequence with the initial assay
- Certainty within the same day
Operations for Repeatability
- All standards and samples weighing out
- New solution preparation and standardization
- All dilution and extraction steps
Between-Day Repeatability
- Between-day repeatability refers to assessing repeatability on separate days by the same operator
Within-Laboratory Reproducibility
- Reproducibility evaluates what happens when one hands over a procedure to another analyst
- Reproduction is like copying of an original by another artist
- It would facilitate team training and give confidence in the control of analytical process
Measuring Reproducibility
- Measures for judging a labs particular assay included submitting it for testing to several laboratories
- It requires a robust assay
Random Error
- Common type of random error can arise from accepting manufacturers' tolerances
Reduction of Systemic Errors
- Can usually be eliminated but true random errors are due to operations in an assay that is not completely controlled
Analytical Blank
- Reagents or solvents that are all used in an analysis without any of the analyte present
- Should reflect all the operations to which the analyte got subjected to in a real sample
Calibration
- Compares the value or values of a particular parameter measured by the system under strictly defined conditions
Detection Limit
- The detection limit is the smallest amount of an analyte that can be detected
Linearity Characteristics
- The best fit of a straight line through the data is the correlation coefficient r
- Correlation coefficient needs top be over 0.99 as regarded as indicating linearity
Method Range
- Method range is related to sensitivity although there are methods such as immunoassays
- Immunoassays measure very small molecule amounts
- They measure over a restricted range of low concentration
Robustness Assessment
- Term refers to how resistant the precision an accuracy of an assay is to small variations in the method such as instrumentation
- Robust assays may not be capable of the highest precision of specificity
Selectivity Method
- Measure of capabilities is measurement of analyte presence
- Most selective analytical method involve chromatographic separation
Analytical Terms
- Qualitative analysis establishes the chemical identity
- Quantitative analysis determines amount and numerical terms
Weighing by Difference
- Used to minimize measuring error
- Suitable vessel weighed and then transferred
- No requirement for complete transfer of the sample
Pharmaceutical Impurities
- Impurities can arise from synthetic starting materials
- Impurities can arise from chemical and side reactions
- Impurities can arise from reagents, solvents and catalysts
- Particulate matter for the atmosphere
- Impurities present in excipients used in the formulation
- Microbial contamination may occur
- Incomplete mixing of drugs with formulation excipients
Sample Preparation Purpose
- Involves separation from dosage form or biological sample
- Ensures removal of interfering material
Extraction Principles
- Removes insolubles or oily excipients
- Detailed extraction for monitoring low drug levels in biological fluids
Tablet and Capsule Considerations
- Usually consist of a filler, the example is lactose
- Fillers consist of sugar polymers
- These may cause interference
Suspension and Solution Analysis
- In suspensions and solutions, dyes are water-soluble so they can be easily extracted
- Often contain organic preservatives
- Compounds need to be removed prior to the analysis
Creams and Ointments
- Non ionic surfactants use in creams and ointments
Useful Extraction Technique
- Centrifugation allows for extraction which involves the use of the centrifugal force for the separation
Solvent Use
- Solvent extractions included uses of pH/pKa partitioning and lipid/aqueous
- Extractions are used to remove unwanted interfering components
Solid Phase Extraction (SPE)
- Involves liquids or gases moving through a column
- Selective extraction, and washing known
Ultrafiltration Method
- Sample pressed by centrifugation through membrane filter
Chromatography
- Adsorption and partition
Immunoassay Methods
- Uses antibody to analyze drug sample
Volumetric Analysis
- Analysis accurate measurement with volume
Design of Assay
- Functional group on molecules react rapidly
British Pharmacopoeia (BP)
- Legally enforceable document produces annually
Endpoint Indication
- Detected by use of suitable indicator
Back Titrations
- Analysis is carried out
- Then repeated no sample is present
Non Aqueous Titrations
- Carried out in the absence of water
- Drugs are very weakly basic
REDOX titrations
- Processes of oxidationreduction
Oxidation
- Defined as loss of hydrogen
Reduction
- Defined as the gain of hydrogen
Complixometric Titrations
- Type on relying formations a stable soluble compound
Argentometric titrations
- Assays all involve silver nitrate
Karl Fischer Titration
- Determination water and used a pharmaceutics
Capillary Electrophoresis
- Analytical technique, ions separated
- Electrophoretic mobility with use of applied voltage
Uses for Techniques
- DNA fingerprints and genotype identification
- Pharmaceutical analysis
Electrophoresis Processes
- Sample ions mobile to influence
Electrophoretic Mobililty
- Dependent upon the charge
Electrosmotic Flow (EOF)
- Caused by applying high voltage to electrialized capilary
Refractometry Background
- Speed where light travel changed
Refractometry Index
- Unit less number to temperature
Used For
- Purity sample and more
Definition
- Medium change
Importance Temperature
- Values are adjusted to 20 degrees
Polarimetry
- Light electro magnetic propogates space
Used For
- Sugar or and to test purity
Analytical Spectroscopy
-
Science of determining how much
-
Instruments a spectrophotemeter
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