Scribd
Upload
163 views

Laboratory 8 (Minimum Fill Volume)

The document describes testing the minimum fill volume of 3 batches of 60mL paracetamol suspension. Each batch was measured 3 times using a measuring cup, with all trials showing a volume of 60mL. This meets the USP criteria of having an average volume equal to or greater than the labeled amount of 100%.

Uploaded by

Diana Mae
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
163 views

Laboratory 8 (Minimum Fill Volume)

The document describes testing the minimum fill volume of 3 batches of 60mL paracetamol suspension. Each batch was measured 3 times using a measuring cup, with all trials showing a volume of 60mL. This meets the USP criteria of having an average volume equal to or greater than the labeled amount of 100%.

Uploaded by

Diana Mae
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 4

Unlayao, Diana Mae

Generic name: Novamol


Manufacturer: Novagen Pharmaceuticals Co., Inc.
Address:#7 Jose Cruz St. Bo Ugong, Pasig City
Lot no: DRP-670
Batch no. : I2058
Expiry date: March 22
RESULTS

PARACETAMOL Trial 1 Trial 2 Trial 3


Quantity (mL) 60 60 60
Average 60 (100%) 60 (100%) 60 (100%)
Standard deviation 0 0 0
Disposition Passed Passed Passed

The three (3) 60mL paracetamol suspension has been subjected to measuring using
a small measuring cup with a maximum measurement of 200mL. Minimum fill test will
be performed to compare the weight or quantity of the paracetamol from the container
delivered into the measuring cup. By that, it will help in assessing the content uniformity
of the products.

All three paracetamol suspension, when delivered into the measuring cup , I
waited 5 minutes for the liquids to be poured completely into the measuring cup. In the
first trial, I got the same quantity of 60mL, the same with the other two (2) trials. To get
the average of them, I added the quantity of the three (3) trials and divided it into three
and got an average of 60. The standard deviation is zero because the average is equal to
the quantity that was computed.

According to the USP's criteria, the accepted minimum fill deliverable volume
should have an average that is not less than 100% of the labeled amount and the labeled
amount should be greater than 100% to pass the test. Since the average is not less than
100% the disposition of the test for the three (3) trials are passed.
V. Questions

1. What is the acceptable range for minimum fill deliverable volume.

According to the USP, the minimum fill deliverable volume test have the acceptance
criterion that the average content of all samples test must not be less than 100% of the
labeled amount. Filling volume target should be greater than 100% of the labeled amount.

2. Enumerate other methods used for measurement of minimum fill deliverable


volume.

Minimum fill deliverable volume is a test to provide assurance that oral liquids, when
transferred from the original container, delivers the volume of dosage form on the label
of the article. It is applicable for products that contains not more than 250mL.

Test Preparations

For oral solutions, oral suspensions, and other oral liquid dosage foms, shake the contents
of the container individually

Procedure

 Gently pour the contents of each container to avoid air bubble formation into
separate dry graduated cyclinder of a rated capacity not exceeding two and a half
times the volume to be measured, and calibrated ''to contain''.
 Allow each container to drain for a period of time not exceeding 30 minutes.
 When free from air bubbles, measure the volume of each mixture.
 Alternatively, in the case of products of low volume packaged in single-unit
containers, the volume can be computed as follows: a. Discharge the container
contents into a suitable tared container b. Determine the weight of the contents and
c. Compute the volume after determining the density.
References:

https://studylib.net/doc/8140302/establishing-target-fills-for-semisolid-and-liquid-
dosage...

http://www.uspbpep.com/usp29/v29240/usp29nf24s0_c698.html

You might also like