PHAN LAB Midterm Liquid Dosage Form

Quality Control

Its main objective in the Pharmaceutical Industry is to test the drugs in their various stages of production, verifying that they can proceed to the next stage and release the manufacturing process following the regulations and specifications required for consumption.

Quality Control

In the physical-chemical laboratory, controls of all types are carried out, from the simplest to the most complex. We can mention simple analyses of the product’s appearance, DELIVERABLE VOLUME, VISCOSITY, Ph, and so on.

Official test

Unofficial test

Two types of quality control tests

• Weight variation test

• Drug content (assay)

• Disintegration time test

• Dissolution test

• Moisture content

Official Quality Control Tests

• Thickness

• Hardness

• Friability

• Organoleptic characters (Color, odor, taste)

Unofficial Quality Control Tests

Organoleptic evaluation

assesses the sensory characteristics of products, such as their taste, smell, appearance, and texture.

Deliverable volume

General chapters: <698>

<698>

Deliverable volume General Chapter

<698> Deliverable Volume

designed to provide assurance that oral liquids will, when transferred from the original container, deliver the volume of dosage form that is declared on the label.

<698> Deliverable Volume

The tests apply whether the products are supplied as liquid preparations or liquid preparations that are constituted from solids upon the addition of a designated volume of a specific diluent.

The average volume of liquid obtained from the 10 containers is NLT 100%, and the volume of each of the 10 containers lies within the range of 95%–110% of the volume declared in the labeling. If (A), the average volume is less than 100% of that declared in the labeling, but the volume of no container is outside the range of 95%–110%, or if (B), the average volume is NLT 100% and the volume of NMT 1 container is outside the range of 95%–110%, but within the range of 90%–115%, perform the test on 20 additional containers. The average volume of liquid obtained from the 30 containers is NLT 100% of the volume declared in the labeling; the volume obtained from NMT 1 of the 30 containers is outside the range of 95%–110%, but within the range of 90%–115% of the volume declared on the labeling.

Acceptance criteria: for single-dose container

The average volume of liquid obtained from the 10 containers is NLT 100%, and the volume of no container is less than 95% of the volume declared in the labeling. If (A), the average volume is less than 100% of that declared in the labeling, but the volume of no container is less than 95% of the labeled amount, or if (B), the average volume is NLT 100% and the volume of NMT 1 container is less than 95%, but is NLT 90% of the labeled volume, perform the test on 20 additional containers. The average volume of liquid obtained from the 30 containers is NLT 100% of the volume declared in the labeling; the volume of liquid obtained from NMT 1 of the 30 containers is less than 95%, but NLT 90% of that declared in the labeling.

Acceptance criteria: for multiple-dose container

viscosity

General chapters: <912>

<912>

Viscosity General chapters

Viscosity

The principle of the method is to measure the force (torque) acting on a rotor when it rotates at a constant angular velocity or rotational speed in a liquid.

Rotational rheometers/viscometers

are used for measuring the viscosity of fluids, both Newtonian and non-Newtonian.

Shear-thinning or pseudoplastic

These fluids become less viscous as the shear rate increases. Examples include ketchup, yogurt, and certain types of paint.

ketchup, yogurt, and certain types of paint.

Shear-thinning or pseudoplastic examples

Shear-thickening or dilatant

These fluids become more viscous as the shear rate increases.

cornstarch and water mixtures (oobleck) and some types of industrial slurries.

Shear-thickening or dilatant Examples

Thixotropic

These fluids become less viscous over time when subjected to constant stress or shear. However, their viscosity increases again once the stress is removed. Examples include certain types of clay suspensions and printing inks.

Rheopectic

These fluids become more viscous over time when subjected to constant stress or shear. Their viscosity decreases when the stress is removed.

Cylinder spindle

Disk-shaped spindle

Two types of spindle viscometer

pH

General chapters: <791>

<791>

pH General chapter

pH

is a measure of the acidity or alkalinity of a solution.

pH

is a measure of the concentration of hydrogen ions (H⁺) in a solution.

"power of hydrogen"

pH stands for

Acids

were substances that had a sour taste, were corrosive, and reacted with substances called bases.

bases

Substances that had a bitter taste, made skin slippery on contact, and reacted with acids

pH scale

pH meter

is a scientific instrument used to measure the pH of a solution accurately.

• a pH probe,

• an electronic meter, and

• a reference electrode.

pH meter consists of

pH probe

is a specialized sensor designed to measure the pH of a solution. It typically consists of a glass electrode with a pH-sensitive membrane at the tip.

pH probe

This membrane is sensitive to the concentration of hydrogen ions (H⁺) in the solution.

pH probe

When this is immersed in a solution, the hydrogen ions in the solution interact with the pH-sensitive membrane, causing a voltage to develop across the glass electrode. This voltage is proportional to the pH of the solution.

Electronic Meter

is the device that reads the voltage generated by the pH probe and converts it into a pH value.

Electronic Meter

It typically includes a display screen that shows the pH reading.

electronic meter

may also have features such as temperature compensation, calibration options, and data logging capabilities.

Litmus paper

is a simple and widely used tool for testing the acidity or alkalinity of a solution.

Litmus paper

It consists of small strips of paper impregnated with a mixture of dyes derived from lichens.

Acids

it ionizes to form hydrogen(+) ions in aqueous solution.

Bases

It ionizes to form hydroxide ions OH(-) in aqueous solution.

Arrhenius theory

Acid → produces H⁺ (hydrogen ions) in solution

Base → produces OH⁻ (hydroxide ions) in solution

Bronsted-lowry theory

According to this theory, an acid-base reaction involves the transfer of a proton from the acid (the proton donor) to the base (the proton acceptor).

Bronsted-lowry theory

This transfer results in the formation of a conjugate acid-base pair.

Ionization constant (Ka)

It indicates the relative strength of the acid or base

stronger (more ionized)

An acid with a Ka of 1 x 10‑1 is ________ than one with a Ka of 1 x 10‑3

weaker (less ionized)

a base with a Ka of 1 x 10-7 is ________ than one with a Ka of 1 x 10-9.

pKw

the negative logarithm of water ion constant,

pKa

negative logarithm of acid dissociation constant

pKb

negative logarithm of base dissociation constant