||1. Levigate creams together until a uniform mixture is obtained.
2. Transfer to ointment jar and label.
||Assign expiry date using USP 795 Guidelines, since no stability data available.
USP 795 guidelines - Solid Formulations:
"Where the manufactured drug product is the active ingredient source - not later than 25% of the time remaining until the preparation expiration date or 6 months, whichever is earlier.
Where USP or NF is the active ingredient source - 6 months"
THIS FORMULATION IS NOT BASED ON LITERATURE, but is from unpublished data, historical use or physician/pharmacy experience.
|| Ointment Jar
||For External Use Only|
||Store at Room Temperature
|Storage/Expiry:||Room Temperature: 6 months|
|Last Date Revised:
|References:||USP 34 – NF 29, 2nd Volume 1. Chapter 795: Pharmaceutical compounding – Nonsterile preparations. Rockville, MD, USA: United States Pharmacopeial Convention; 2010 |