Pharmaceutical Quality Assurance & Testing

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Questions and Answers

What is the primary principle of mass spectrometry?

Separation based on mass to charge ratio (m/z ratio) (correct)

Absorption of electromagnetic radiation by samples

Partitioning analytes between mobile and stationary phases

Detection of impurities using complex fingerprints

What is a significant limitation of infrared spectrometry?

Ability to detect minor impurities

Complex sample preparation requirements (correct)

Cost of instruments is very low

High precision in quantification

Which analytical technique is noted for its strong performance in accuracy and precision?

Thin layer chromatography

Mass spectrometry

High performance liquid chromatography (correct)

Gas chromatography

What is one application where chromatography is particularly beneficial?

Drug potency measurement Signup and view all the answers

What does Lipinski’s rule of five primarily address?

Drug likeness based on molecular properties Signup and view all the answers

Why is bioanalysis important in the pharmaceutical industry?

It allows for quantitative measurement of drugs and metabolites Signup and view all the answers

What is a common extraction method used in pretreatment in analysis?

Solid phase extraction Signup and view all the answers

What characteristic of the bonds determines the wavelength absorbed in infrared spectrometry?

Nature of the bond absorbing it Signup and view all the answers

What is one limitation of mass spectrometry?

It requires highly skilled operators due to complexity Signup and view all the answers

In which scenario is chromatography least applicable?

Examining protein structures in a solution Signup and view all the answers

What is the primary purpose of quantitative analysis in the context of substance analysis?

To ascertain the amounts and proportions of chemical constituents Signup and view all the answers

Which term describes the closeness of a measurement to the true value?

Accuracy Signup and view all the answers

Which type of analysis focuses on the nature of chemical constituents rather than their amounts?

Qualitative analysis Signup and view all the answers

What is a critical limitation of titrimetric and chemical analysis methods?

They are not automatable. Signup and view all the answers

What does the term 'intermediate precision' refer to in the context of analytical procedures?

Precision achieved when measurements are taken by different operators Signup and view all the answers

Which principle underlies ultraviolet and visible analysis methods?

Absorption of radiation by excited electrons Signup and view all the answers

What does the term 'friability' refer to in dosage form testing?

The ease with which a tablet breaks or crumbles Signup and view all the answers

What characteristic is emphasized by the precision of an analytical procedure?

Consistency among multiple measurements of the same sample Signup and view all the answers

Study Notes

Dosage Form Testing Examples

Tablets undergo disintegration, friability, hardness, and dissolution testing.
Creams are subject to rheological testing.

Quality Assurance in Medicine

Medicine quality can deviate from standards, but analysis quality must be adequate.
Reformulation is a pre-formulation stage in drug development.

Analytical Techniques

Quantitative Analysis: Determines the amounts and proportions of chemical constituents.
Qualitative Analysis: Identifies the nature of chemical constituents.
Accuracy: Closeness to the true value.
Precision: Closeness of multiple measurements. Levels include repeatability, intermediate precision, and reproducibility.

Titrimetric and Chemical Analysis Methods

Analyte chemically reacts with a standard reagent to estimate sample purity.
Applications include drug, excipient, and formulation assay.
Advantages are high precision, accuracy, robustness, and cost-effectiveness.
Limitations include potential non-selectivity and operator skill requirements.

UV-Visible Spectroscopy

(200-700nm) radiation passes through a solution, exciting electrons and causing absorption.
Measures pKa, dissolution, solubility, reaction kinetics.
Advantages: Easy use, affordability, robustness.
Limitations: Moderate selectivity and not applicable to all solutes.

IR Spectroscopy

(400-4000 cm⁻¹ / 2500-20000 nm) radiation interacts with sample bonds, causing stretching or bending.
Qualitative analysis for excipients and drugs, preliminary compound identification and detection of polymorphisms.
Advantages: unique fingerprint identification.
Limitations: Qualitative, poor quantitative applicability for complex samples, useful only for gross impurities. Not widely used quantitatively due to sample demands.

Mass Spectrometry

Analyte ionization, acceleration, and separation based on m/z ratio.
Applications: Drug identification, impurity characterization, bioanalysis.
Limitations: Expensive, complex technique requiring skilled operators, and less widely used in QC.

Chromatography

Separates mixture components based on partitioning between mobile and stationary phases.
Types include column, thin layer, gas, and high-pressure liquid chromatography (HPLC).
Capillary electrophoresis is a related technique.
Modes include analytical (analysis) and preparative (purification).

HPLC (High-Performance Liquid Chromatography)

Liquid mobile phase, under pressure, through a stationary phase column.
Separation by component interactions with stationary phase.
Monitors exiting components with detectors (e.g., UV-Vis).
Applications: Drug and excipient quantification, stability monitoring, drug/metabolite measurements in biological samples.
Advantages: Performance in analytical metrics, diverse separation/detection, automatability.
Limitations: Sample preparation needed, organic solvent waste.

Bioanalytical Science

Applies biological sciences to study and analyze biological samples.
Large global industry.

Immunoassay

Bioanalytical technique using antibody-antigen reactions for qualitative and quantitative analysis of analytes (drugs, biomolecules, metabolites).

Bioanalysis

Quantitative measurement of drugs, metabolites, biomolecules, and biotics in biological systems.

Pretreatment in Analysis

Extraction removes analytes from complex matrices (formulations, biological fluids).
Methods affect analysis precision and accuracy.
Common examples include solvent and solid-phase extraction.

Druglikeness – Lipinski's Rule of Five

Lipinski's rules of five are not fully covered in the text and need further analysis. The text refers to this concept, but no specific criteria are given for hydrogen bond donors, for example.

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Description

This quiz covers essential topics in pharmaceutical quality assurance and testing, including dosage forms, analytical techniques, and the principles of titrimetric analysis. Explore the importance of accuracy and precision in quantitative and qualitative analysis, as well as the significance of reformulation in drug development.