9.024 - Quality Assessment of Oral and Topical Liquids

SOP No. 9.
024
Title of SOP: Quality Assessment of Oral and Topical Liquids
Original: Yes __ No __ Revision: Yes __ No __ Revision No.: _________

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Responsibility:
The pharmacist-in-charge is responsible for this procedure.
Purpose:
The purpose of this standard operating procedure is to provide a method of documenting physical
quality assessment tests of and observations on oral and topical solutions, suspensions, and
emulsions.
Equipment/Supplies Required:
 Balance
 Graduates
 Microscope
 pH meter
 Physical Quality Assessment Form for Oral and Topical Liquids
 Pycnometer (optional)
Procedure:
A. Conduct the appropriate tests and record the results/observations on the Physical Quality
Assessment Form for Oral and Topical Liquids.
1. Weight/Volume
a. Weigh, accurately, the preparation on a balance or measure the quantity in a graduate.
2. pH
a. Calibrate the pH meter using the standard operating procedure titled SOP: pH Meter—
Use, Care, Cleaning, Maintenance, and Calibration.
b. Determine the pH of the preparation.
3. Specific Gravity
a. Make sure that the pycnometer is clean and dry, if a pycnometer is used.
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Approved by_____________________________________________ Date _____________
Implemented by__________________________________________ Date _____________
b. Weigh the empty pycnometer.
c. Fill the pycnometer with the preparation, being careful not to entrap air bubbles.
d. Weigh the pycnometer a second time.
e. Subtract the first weight from the second weight to obtain the net weight of the
preparation.
f. Divide this weight (grams) by the volume (milliliters) of the pycnometer to obtain the
density/specific gravity of the preparation.
4. Active Drug Assay Results
a. Have representative samples of the preparation assayed for active drug content by a
contract analytical laboratory, as appropriate.
b. Assess the stability of the preparation by storing it at room, refrigerated, and/or frozen
temperatures and repeating the respective assays.
5. Color of Solution
a. Determine the actual color of the preparation by using a color chart (advisable).
6. Clarity
a. Perform a visual evaluation of the clarity of the preparation. A light-dark background

may be used.
7. Globule Size Range
a. Place a drop of the preparation on a glass plate (microscope slide) and illuminate from
the bottom.
b. Estimate the globule size range of the preparation.
8. Rheological Properties/Pourability
a. Determine by visual inspection if the preparation pours easily or with difficulty

(before and after it has set for a period of time).
9. Physical Observation
a. Describe the appearance and organoleptic qualities of the preparation.
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Approved by_____________________________________________ Date _____________
10. Physical Stability
a. Prepare an additional quantity of the preparation, package, and label (for physical
stability observations).
b. Observe on a weekly basis the preparation for signs of discoloration, foreign materials,
gas formation, mold growth, etc.
c. Record a descriptive observation on the Physical Quality Assessment Form for Oral
and Topical Liquids at each observation interval.
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Approved by_____________________________________________ Date _____________
______________________________________________________________________________
Physical Quality Assessment Form for Oral and Topical Liquids
Preparation___________________________________________ Date____________________
Lot/Rx
Number____________________ Form: □ Solution □ Suspension □ Emulsion
Characteristic Theoretical Actual Normal Range
Weight/Volume _________________ _________________ ________________

pH _________________ _________________ ________________
Specific gravity _________________ _________________ ________________
Active drug assay results _________________ _________________ ________________
Initial assay _________________ _________________ ________________
After storage No. 1 _________________ _________________ ________________
After storage No. 2 _________________ _________________ ________________
Color of preparation _________________ _________________ ________________
Clarity (solution) Clear 1 2 3 4 5 Opaque
Globule size range
(emulsion) (est, mm) <1 1-2 2-3 >3
Rheologic properties
(pourability, settling,
resuspendability) Good 1 2 3 4 5 Poor
Sample set aside for physical observation: □ Yes □ No

If yes, results: Date Observation
_______ ______________________________________________________
_______ ______________________________________________________
_______ ______________________________________________________
_______ ______________________________________________________
====================================================================
Approved by_____________________________________________ Date _____________
_______ ______________________________________________________
====================================================================
Approved by_____________________________________________ Date _____________

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SOP No. 9.

Title of SOP: Quality Assessment of Oral and Topical Liquids

Original: Yes No Revision: Yes No Revision No.: _________

The pharmacist-in-charge is responsible for this procedure.

a. Weigh, accurately, the preparation on a balance or measure the quantity in a graduate.

b. Determine the pH of the preparation.

d. Weigh the pycnometer a second time.

4. Active Drug Assay Results

a. Perform a visual evaluation of the clarity of the preparation. A light-dark background

7. Globule Size Range

b. Estimate the globule size range of the preparation.

a. Determine by visual inspection if the preparation pours easily or with difficulty

a. Describe the appearance and organoleptic qualities of the preparation.

Weight/Volume _________ _ ________

Sample set aside for physical observation: □ Yes □ No

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