Pharmaceutical Quality Assurance & Testing

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.

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.