EXPERIMENT 7: DELIVERABLE VOLUME DETERMINATION OF ACETAMINOPHEN ORAL SUSPENSION

PERFORMANCE TESTS

• tests that are conducted to assess the __

drug release from the dosage form

PERFORMANCE TESTS

• conducted to ensure

• batch-to-batch quality; indicates batch reliability

• performance of a dosage form 

DELIVERABLE VOLUME

• A test to assure that all liquids will, when poured from the original container, provide the volume of dosage form that is written on the label 

DELIVERABLE VOLUME

• applied to 

liquid preparations or constituted liquid preparations by a specific diluent that are discharged through pouring

acetaminophen oral suspension

• definition

a suspension of Acetaminophen in a suitable aqueous vehicle. It contains NLT 90.0% and NMT 110.0% of the labeled amount of acetaminophen (C₈H₉NO₂)

acetaminophen oral suspension

• performance test

• Uniformity of Dosage Units <905>
  For single-unit containers: Meets the requirements

• Deliverable Volume <698>
  For multiple-unit containers: Meets the requirements

Single-unit

• discard excess or use up the whole dose

• no preservatives

Multiple-unit

• allows successive withdrawals or multiple portions without affecting integrity and quality of the remaining drug in the container

Procedure

1. Preliminary Sampling

2. Mass Determination of the Contents

3. True Density Determination of the Acetaminophen Oral Suspension

4. Deliverable Volume Determination

A. PRELIMINARY SAMPLING

1. Select not fewer than 30 containers. 

2. Shake the contents of 10 containers individually for 2 mins.

B. MASS DETERMINATION OF THE CONTENTS

1. Discharge the container contents into a suitable tared container (allowing drainage for NMT 10 mins).

2. Determine the mass of the contents.

C. TRUE DENSITY DETERMINATION

1. Get the weight of a 100-mL volumetric flask containing 50.0 mL of water.

2. While on the balance, add approximately 25 g of well-shaken product (from the discharged contents, and gently swirl the contents to mix.

3. Note the total weight. Subtract from this weight the recorded weight in procedure C.1.

4. From a burette, add an accurately measured amount of water to bring the flask contents to volume while gently swirling the contents of the flask. Record the volume taken from the buret.

5. Calculate the density of the sample.

C. TRUE DENSITY DETERMINATION

• formula 

Density = mass of sample (~25 g)/ (50.0 mL - volume of water added to make 100 mL)

D. DELIVERABLE VOLUME DETERMINATION 

1. Divide the mass of the contents with the true density of the suspension.

Deliverable volume (mL) = Mass of contents/True Density

% Labeled volume =

(Deliverable volume/Label claim) x100

AV₁₀ is less than 100%

ONE value lies outside 95% – 110%

FAIL

AV₁₀ is less than 100%

NO value lies outside 95% – 110%

TEST 20 MORE containers

AV₁₀ is not less than 100%

NO value lies outside 95% – 110%

PASS

AV₁₀ is not less than 100%

MORE THAN ONE value lies outside 95% – 110%

FAIL

AV₁₀ is not less than 100%

NOT MORE THAN ONE value that lies outside 95% – 110% but within 90% – 115%

TEST 20 MORE containers

AV₃₀  (10 is from the first determination, remaining is from the “Test 20 more containers”)

AV₃₀  (10 is from the first determination, remaining is from the “Test 20 more containers”)
LESS THAN 100% LV

FAIL

AV₃₀  (10 is from the first determination, remaining is from the “Test 20 more containers”)

NOT LESS THAN 100%,  MORE THAN ONE value lies outside 95% – 110%

FAIL

AV₃₀  (10 is from the first determination, remaining is from the “Test 20 more containers”

NOT LESS THAN 100%, NO value lies outside 95% – 110%

PASS