Recipe - Compounding Worksheet
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These recipes are intended for use by the pharmacy manufacturing departments only.
L-Arginine Hydrochloride Oral Solution (prepared from injection)   100 mg/mL (0.475 mmol/mL of chloride)
Lot No Expiry(mm/yyyy) Ingredients Master Formula
    arginine hydrochloride  250 mg/mL  INJ  l-arginine 
    Water, sterile       qs to 
Recipe Total Quantity:
Final Quantity Desired: mL

Directions: 1. Withdraw required amount of l-arginine and transfer to a graduated cylinder.
2. QS to final volume with sterile water and mix well.
3. Transfer to final container and label.

Notes L-arginine solution for injection must be diluted to 100 mg/mL solution for ORAL use.

This formulation is recommended for ORAL use in metabolic alkalosis patients and in neonates with resistant hypochloremia or necrotizing enterocolitis.

Although this recipe can be used for short-term ORAL use, it is NOT recommended in patients with Urea Cycle Disorders, l-arginine BASE recipe is preferred (see recipe in AHS Recipe Database).

Sabex faxed data circa 2000 is not available, therefore assign beyond use date using NAPRA Guidance Document For Pharmacy Compounding Of Non-Sterile Preparations:
For Water Containing Oral Formulations: The BUD is not later than 14 days when stored at controlled cold temperatures.

Packaging:  Amber Plastic Bottle

Auxiliary Labels: Refrigerate

Storage/Expiry:Refrigerator: 14 days

Last Date Revised: 8-Sep-21

References:Sabex Fax Communication August 2000, In-house Stability Study on L-arginine injection diluted in sterile water for injection (SWI), August 2000 and October 2002.
Sabex stated that diluted L-arginine injection in SWI to a 100 mg/mL concentration is chemically stable for 28 days at room temperature or refrigerated.

AHS Drug Information Service. Previous Question #20703. What should the BUD be for L-Arginine Hydrochloride Oral Solution (prepared from injection)? 2021 Aug 24. Available at:
https://webappsint.albertahealthservices.ca/Pharmacy/PS_DI/admin_user/view_request.aspx?id=20703

Since Sabex fax circa 2000 is not saved and not available to DI staff for perusal, we will revert to the NAPRA BUD:

Assign beyond use date using NAPRA Guidance Document For Pharmacy Compounding Of Non-Sterile Preparations:
For Water Containing Oral Formulations: The BUD is not later than 14 days when stored at controlled cold temperatures.
  For Water Containing Oral Formulations: The BUD is not later than 14 days when stored at controlled cold temperatures.
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
   6-Dec-2021         


This content is provided for general information purposes only. It is not intended to replace consultations with a health care professional or to provide medical advice, diagnosis or treatment. Always seek the advice of a physician or other qualified health care provider with any medical or health questions. Alberta Health Services accepts no responsibility for any modification or redistribution of this document and is not liable for any actions taken by individuals based on the information provided, or for any inaccuracies, errors, or omissions in the information in this document. These recipes are to be used as a reference and are not intended to be master formulation records. Not all recipes may be compliant with NAPRA or other standards.