Dosage form analysis refers to the scientific evaluation of pharmaceutical products to ensure their quality, safety, and efficacy. A dosage form is the physical form in which a drug is produced and administered, such as tablets, capsules, injections, creams, or suspensions. Analyzing these forms is crucial in pharmaceutical development, manufacturing, and quality control.
Essential Analytical Parameters
Identity Verification
Confirming the presence of the correct active pharmaceutical ingredient (API).Measuring the exact amount of API and excipients
Measuring the exact amount of API and excipients.Purity Assessmen
Detecting impurities, degradation products, or contaminantsStability Testing
Evaluating how the dosage form maintains its properties over time under various conditions.Bioavailability and Release Profile
Assessing how the drug is released and absorbed in the body.Common Analytical Techniques
High-Performance Liquid Chromatography (HPLC)
Widely used for quantifying APIs and impurities.
UV-Visible Spectroscopy
Useful for quick identification and concentration analysis.
Mass Spectrometry (MS)
Provides detailed molecular information.
Dissolution Testing
Measures the rate and extent of drug release from solid dosage forms.
Microscopy and Particle Size Analysis
Important for suspensions and emulsions.
Regulatory Importance
Regulatory agencies like the FDA and EMA require rigorous dosage form analysis to approve new drugs and monitor existing ones. These analyses ensure that medications are consistent, effective, and safe for public use.
