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METHOD OF PREPARATION
1. Calculate the required quantity of each ingredient for the total amount to be prepared.
2. Accurately weigh and/or measure each ingredient. The mafenide acetate (11.24 g) is equivalent to 8.5 g of mafenide base.
3. Mix the mafenide acetate with the propylene glycol to form a smooth paste.
4. Incorporate the paste into the selected vehicle (hydrophilic ointment, Dermabase, Vanicream, etc) and mix until uniform.
5. Package and label.
PACKAGING
Package in tight, light-resistant containers.1,2
LABELING
For topical use. Use only as directed.
STABILITY
A beyond-use date of 6 months can be used for this preparation.1
USE
Mafenide acetate cream is an anti-infective cream for topical administration to burn wounds.2
QUALITY CONTROL
Procedures that can be used for performing physical quality assessment of this cream are: theoretical weight compared to actual weight; pH; specific gravity; active drug assay; color; clarity; texture-surface; texture-spatula spread; appearance; feel; rheological properties; physical observations.3
DISCUSSION
Mafenide acetate (C^sub 7^H^sub 10^O^sub 2^S X C^sub 2^H^sub 4^O^sub 2^, MW 246.28) occurs as a white to pale yellow,...