Laboratory Procedure
A. Manual Filling of Hard Gelatin Capsules
Compound, label, and dispense the following prescription: (PREPARE
12 CAPSULES  Dispense seven (7) capsules and save five (5) capsules
for analysis. Calculate for 14 capsules.)
The University of North Carolina Rx# 61701
School of Pharmacy
Chapel Hill, NC
Phone: 5551234 DEA# PS0079411
Name: June B. Ride Date: Today
Address: Sendabills Drive, Chapel Hill NC 27599 Phone: 9166777
Rx
Salicylic Acid 4 mg
Lactose q.s. 350 mg
M.Ft.D.T.D. caps #12
Sig: 1 cap q AM x 2 d, then return to clinic
No refill
Able Andredy,M.D.
Product selection permitted Dispense as written

Amount of Salicylic Acid Needed for 14 Capsules _________
Preparation of trituration
Make the necessary calculations and describe how the trituration
will be prepared.
Salicylic Acid 
____________ mg 
Lactose 
____________ mg 
Total Weight of Trituration 
____________ mg 
Give the compounding formula
Total Amount of Trituration Needed to Prepare 14 Capsules (i.e., your chosen aliquot size) 
_____________ mg 
Total Amount of Lactose Needed to Make 14 Capsules of Desirable Weight 
_____________ mg 
Total Weight of 14 Capsules 
_____________ mg 
Capsule Size Needed 
_____________ 
Describe the compounding procedure
View a video demonstration on capsule punching
Inspection of Final Preparation ___________________
B. Evaluation of Capsules
NOTE: Capsule contents should be analyzed in
the same order as weighed in the weight variation test so that
a comparison between weight variation and content uniformity can
be made.
1. Weight Variation
 Using the balance, weigh each capsule, taking care to preserve
the identity of each.
 Empty the contents of each capsule into a flask and
weigh the empty capsule shell. Determine the weight of the contents
of each capsule.
 Calculate the following for the "% of Intended Weight":
 the mean
 standard deviation
 relative standard deviation
Capsule # 
Weight of Finished Capsule 
Weight of Empty Capsule 
Weight of Contents 
% of Intended Weight 
1 




2 




3 




4 




5 




mean = ________
standard deviation = _______
relative standard deviation = _________ 
2. Content Uniformity
 To each flask containing the contents of one capsule,
add 100 ml of 0.01 N NaOH. Prepare
a blank of 0.01 N NaOH.
Using a set of reference standards of known concentration,
prepare a Beer's Law plot. Read the absorbance of each standard
and sample at 310 nm using the spectrophotometer. Using the slope
and intercept of the Beer's Law plot to convert absorbance to
concentration, calculate the weight of active ingredient in each
capsule.
 Calculate the following for the "% of Labelled Claim":
 the mean
 standard deviation
 relative standard deviation
 Prepare a Beer's Law plot of the following salicylic acid standards.
Attach graph.
Salicylic Acid 
Absorbance @ 310 nm 
Regression Analysis 
0.00 mg/ml 
__________________ 
intercept = _________ 
0.02 mg/ml 
__________________ 

0.04 mg/ml 
__________________ 
slope = ____________ 
0.06 mg/ml 
__________________ 

0.08 mg/ml 
__________________ 
R^{2} = ______________ 
0.10 mg/ml 
__________________ 

Capsule # 
Absorbance 
Concentration 
Amount in Capsule (mg) 
% of Labelled Claim 
1 




2 




3 




4 




5 




mean = ________
standard deviation = _______
relative standard deviation = _________ 
C. Discussion
 During commercial preparation, which "Uniformity of Dosage
Units" test would be applied to the capsules you prepared,
weight variation or content uniformity? Explain.
 The USP24/NF19 requires that extemporaneous prepared capsules be 90%  110% of the theoretical weight. Do your capsules meet these standards in terms of the "% of Intended Weight"?
 Is there a correlation between weight variation and content
uniformity in the capsules you prepared? How did you determine
if a correlation existed? How would you account for variations
from the expected correlation?