QA & QC Microbial Assay and Analytical Techniques

These flashcards cover essential terminology and definitions related to microbial assay, titrimetric analysis, and quality control in pharmaceuticals.

Microbial Assay

A procedure to evaluate the effects and efficacy of antibiotics using microorganisms.

Penicillin G

An antibiotic used against bacterial infections, particularly effective against Staphylococcus aureus.

Karl-Fischer Titrimetry

A method for determining water content in samples using Karl-Fischer reagent.

Bulk Density

The mass of a substance divided by the volume it occupies, often including the air space between particles.

Tapped Density

The mass of a substance divided by the volume it occupies after tapping, rearranging particles closer together.

Angle of Repose

The maximum angle of a slope at which a substance can remain stable without sliding.

Compressibility Index (CI)

A parameter indicating the change in volume of a powder under pressure, computed using untapped and tapped volumes.

Hausner Ratio (HR)

A measure of the flowability of a powder, derived from the ratio of tapped density to bulk density.

Tablet Hardness Test

A test that measures the force required to break a compressed tablet, assessing its strength.

Friability

The measure of a tablet's ability to withstand mechanical stress, defined as the percentage weight loss after tumbling.

Disintegration Test

A test for assessing the time it takes for a tablet to break down into smaller particles in a specific medium.

Dissolution Test

A measure of the rate and extent to which the active ingredient of a drug dissolves in a specified medium.

Sterility Test

A procedure to ensure a sample is free from viable microorganisms, using specific nutrient media.

Pyrogen Test

A test to determine if a substance induces a fever response in suitable test animals.

Long-term Stability Studies

Tests to assess a product's behavior and quality over an extended period under normal conditions.

Accelerated Stability Studies

Tests that utilize elevated conditions to predict the long-term stability of a substance in a shorter time frame.

Titrimetric Analysis

A quantitative analytical method used for determining the concentration of a specified substance through titration.

Acidimetry

A type of titrometry involving a titrant that is an acid.

Alkalimetry

A type of titrometry involving a titrant that is a base.

Azo Dyes

Synthetic dyes characterized by the presence of an azo group (-N=N-), commonly used as indicators.

Permanganometry

An analytical method using potassium permanganate as the titrant in redox reactions.

Iodometry

An analytical method involving the use of iodine in titrations for determining the concentration of reducing agents.

Turbidity

The cloudiness or haziness of a liquid caused by large numbers of individual particles.

Moisture Content

The amount of water contained in a substance, often measured as a percentage.

Quality Assurance (QA)

A systematic process to ensure that products meet specified quality standards.

Quality Control (QC)

A process that tests whether the products meet quality standards.