Pharmaceutical Analysis - Quality Control I

A collection of flashcards focused on key concepts in Pharmaceutical Analysis and Quality Control, based on the lecture notes.

Pharmaceutical Analysis

The applied analytical chemistry focused on drugs, developing methods for the qualitative and quantitative determination of therapeutic or cosmetic substances.

Active Ingredients (API)

The component in a pharmaceutical product that provides the intended therapeutic effect.

Quality Control

The process of ensuring that pharmaceutical products meet the required specifications for identity, purity, and potency.

Standard Operating Procedures (SOPs)

Documented procedures and guidelines to ensure consistency and compliance in testing and production processes.

Good Manufacturing Practices (GMP)

Regulations that require manufacturers to maintain proper practices in manufacturing, testing, and quality assurance of pharmaceuticals.

Spectrophotometry

An analytical technique used to measure the amount of light that a substance absorbs by measuring the intensity of light at different wavelengths.

Chromatography

A method used to separate mixtures of substances into their components.

Identification Tests

Procedures used to verify the identity of a pharmaceutical substance through physical, chemical, or spectroscopic properties.

Purity Tests

Tests conducted to assess the quality and absence of impurities in a pharmaceutical product.

Quantitative Analysis

A method to determine the amount or concentration of a substance in a given sample.

Analytical Techniques

Different approaches used for the analysis of samples, including titrimetric, spectrometric, and chromatographic methods.

Impurities

Unwanted substances that may be present in pharmaceuticals either as contaminants or as by-products of production.

Equivalence Testing

A procedure to ascertain that different batches of drugs are of equivalent quality and efficacy.

Residual Solvents

Solvents that remain in pharmaceuticals after the manufacturing process, which must be controlled for safety.

pH Testing

A method to measure the acidity or alkalinity of a solution, crucial for ensuring drug stability.

Loss on Drying (LOD)

A measurement of the amount of moisture or volatile content in a pharmaceutical product.

Melting Point

The temperature at which a solid becomes a liquid, used to identify and assess the purity of a substance.

Standardization

The process of establishing and implementing technical standards based on specific protocols and requirements.

Stability Testing

An evaluation of the stability of a drug substance or product under various environmental conditions.

Quality Assurance

A systematic process to ensure that products meet the required quality standards throughout the manufacturing process.

Validation

The process of proving that an analytical method is suitable for its intended purpose.

HPLC (High-Performance Liquid Chromatography)

An advanced type of liquid chromatography used for the separation and quantification of compounds in a mixture.

TLC (Thin Layer Chromatography)

A simple and inexpensive method for checking the purity of a compound or for separating non-volatile mixtures.

Batch Testing

The assessment of a specific batch of pharmaceuticals to verify compliance with predefined specifications.

Equivalence Document

A documented comparison of two pharmaceutical products to confirm they meet the same quality and efficacy standards.