Recipe - Compounding Worksheet
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These recipes are intended for use by the pharmacy manufacturing departments only.
Phenylbutyrate Sodium Oral Liquid   50 mg/mL
Lot No Expiry(mm/yyyy) Ingredients Master Formula
    sodium phenylbutyrate     PWD  (granules) 
    Water, sterile       qs to 
Recipe Total Quantity:
Final Quantity Desired: mL

Directions: 1. Weigh required amount of sodium phenylbutyrate granules on a glass weigh boat.
2. Fill a glass volumetric flask with 80% of required sterile water. Add a stir bar and start mixing at 200-300 RPM on the magnetic stir plate.
3. Slowly pour sodium phenylbutyrate granules through a funnel into the volumetric flask, increase speed to 800 RPM and mix for 60 minutes.
4. Using the stir bar retriever, remove the stir bar and qs to final volume with sterile water.
5. Cover the flask with a stopper or parafilm and turn once to mix.
6. Filter solution through a stainless steel sieve (250 micrometers) into a large, appropriate sized, graduated cylinder. Note: Granules contain ingredients that are not water soluble. A significant amount of residue will remain on the sieve. The solution will be cloudy-white in appearance.
7. Transfer into a glass amber bottle. Cover final container with aluminum foil.

Notes Each gram of sodium phenylbutyrate granules contains 483 mg of sodium phenylbutyrate.

As per Pheburane manufacturer (Medunik), cover with aluminum foil is used to protect final product from light.

THIS FORMULATION IS NOT BASED ON LITERATURE, but is from unpublished data, historical use or physician/pharmacy experience.

Packaging:  Amber Glass Bottle

Auxiliary Labels: Protect From Light
  Refrigerate
  Shake Well

Storage/Expiry:Refrigerator: 7 days

Last Date Revised: 9-Sep-21

References:Pheburane Product Monograph. Medunik Canada. Dec 6, 2017.
 
National Association of Pharmacy Regulatory Authorities (NAPRA). Guidance Document For Pharmacy Compounding Of Non-Sterile Preparations. Ottawa, ON: National Association of Pharmacy Regulatory Authorities (NAPRA); 2018.
Available at: https://napra.ca/sites/default/files/documents/Mdl_Stnds_Pharmacy_Compounding_Nonsterile_Preparations_Guidance_June2018_FINAL.pdf

Completed Compound Check
Lot NoDate Prepared Expiry DateTechnicianPharmacist
   29-Nov-2021         


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