[ANALYSIS-LAB-FIN-01] IPQC HOMOGENEITY TESTING IN SUSPENSIONS

THIS FLASHCARDS IS ABOUT [ANALYSIS II] HOMOGENEITY TESTING IN SUSPENSIONS.

Sedimentation Volume

It is the ratio of the ultimate (final) volume of the sediment (Vu) to the original total volume of the suspension (Vo) before settling.

1. Liquid

2. “Uniform Mix”

3. Concentrated Layer

The goal of sedimentation volume is to determine how much of the (1)_____ remains as a “(2)________” versus how much has settled as a (3)__________.

High Sedimentation Volume

This importance of IPQC Homogeneity Testing in Suspensions indicates a stable, flocculated suspension that is easy to re-disperse.

Suspension

Sedimentation always correlates to?

Volume

This plays a lot of roles in terms of bioavailability when being measured.

Supplemental Info

To calculate the sedimentation volume (F), we use the following equation:

• V_u: Final settle volume of the sediment

• V_o: Original total volume of the suspension

V_u

In the equation of sedimentation volume (F), this is the final settle volume of the sediment.

V_o

In the equation of sedimentation volume (F), this is the original total volume of the suspension.

F = 1.0

This numerical value of (F) indicates no visible settling. The suspension is perfectly homogenous. It is also the ideal value.

F = 0.5

This numerical value of (F) the solid particles have settled to occupy 50% of the total volume.

F < 0.1

This numerical value of (F) indicates a significant settling; the drug is concentrated in a tiny layer at the bottom.

F > 1.0

This numerical value of (F) occurs when the network of particles (floccules) is so loose it occupies more space than the original liquid (rare but possible in highly flocculated system).

Stable

The higher the sedimentation volume, it is most likely?

1. Sampling

2. Transfer

3. Settling

4. Measurement

5. Calculation

6. Redispersibility

What are the (6) IPQC Procedure?

Hint: SAT-SEM-CAR

Sampling

IDENTIFY THE IPQC PROCEDURE:

Take a known volume (V_o) of the suspension (e.g., 100 mL).

Transfer

IDENTIFY THE IPQC PROCEDURE:

Pour it into a graduated cylinder.

Settling

IDENTIFY THE IPQC PROCEDURE:

Allow the cylinder to stand undisturbed for a set period of time (e.g., 24 hrs or 7 days).

Measurement

IDENTIFY THE IPQC PROCEDURE:

Record the height/volume of the sediment layer (V_u).

Calculation

IDENTIFY THE IPQC PROCEDURE:

Apply the sedimentation volume (F) formula.

Redispersibility

IDENTIFY THE IPQC PROCEDURE:

Invert the cylinder to see how many “shakes” it takes to return to a homogenous state.

1. Particle Size

2. Viscosity

3. Zeta Potential

What are the (3) Factors Affecting Sedimentation?

(To maintain a high (F) value and homogeneity, IPQC monitors:)

Hint: PVC

Particle Size

IDENTIFY THE FACTOR AFFECTING SEDIMENTATION:

Smaller particles settle slower (Stoke’s Law).

Stoke’s Law

What law states that “smaller particles settle slower”?

Viscosity

IDENTIFY THE FACTOR AFFECTING SEDIMENTATION:

Thicker liquids (using agents like Xanthan Gum) to slow down settling.

Xanthan Gum

This agent is used in thicker liquids to slow down settling.

Zeta Potential

IDENTIFY THE FACTOR AFFECTING SEDIMENTATION:

Electrical charges that keep particles from clumping into a hard cake.

High (F) Value

Better homogeneity + easier re-dispersion.

Low (F) Value

Risk of “Caking” and inaccurate dosing.

Formulation (viscosity or wetting agents)

If the (F) drops below the validated limit during IPQC, the _________ (viscosity or wetting agents) must be adjusted.

• Tablets

• Capsules

• Liquids/Suspensions

• Semisolids (Creams)

What are the (4) Common IPQC Tests by Dosage Forms?

Hint: TCLS

• Weight variation

• Hardness

• Friability (Brittleness)

• Disintegration Time

What are the (4) Key IPQC Tests for Tablets?

Hint: WH-FD

• Shell moisture content

• Fill weight

• Locking length

What are the (3) Key IPQC Tests for Capsules?

Hint: SFL

• pH value

• Viscosity

• Sedimentation Volume (F)

• Specific Gravity

What are the (4) Key IPQC Tests for Liquids/Suspensions?

Hint: pV-SS

• Homogeneity

• Particle size

• Viscosity

• Leakage test for tubes

What are the (4) Key IPQC Tests for Semisolids (Creams)?

Hint: HP-VL

1. FPQC

2. “Preventative maintenance”

While (1)________ happens at the very end (the “final exam”), IPQC is “(2)__________”.

IPQC

Catches errors during the run (e.g., “The tablets are getting too soft, increase the pressure”).

FPQC

Confirms the batch is safe after it’s done (e.g., “The batch is perfect/failed, release/reject it”).