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METHOD OF PREPARATION
Note: This formulation should be prepared in a laminar airflow hood in a deanroom or via isolation barrier technology by a compounding pharmacist -with validated aseptic skills using strict aseptic technique. This is a high-risk preparation.
1. Calculate the required quantity of each ingredient for the total amount to be prepared.
2. Accurately weigh and/or measure each ingredient.
3. Add the citric acid, magnesium oxide, and sodium carbonate to about 90 mL of sterile water for irrigation and mix well.
4. Add sufficient sterile water for irrigation to volume and mix well.
5. Filter through an appropriate sterile 0.2-pm filter into individual-dose sterile containers.
6. Package and label.
PACKAGING
Package in sterile containers.1
LABELING
Keep out of reach of children. Use only as directed. For professional use only.
STABILITY
If not sterility tested: A beyond-use date of up to 24 hours at room temperature, up to 3 days at refrigerated temperature (2° to 8°C), or up to 45 days frozen can be used for this preparation.
If sterility tested: A beyond-use date of up to 6 months can...