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Rx
For 100 mL
Naltrexone 100 mg
Ascorbic acid 500 mg
Sodium benzoate 100 mg
Glycerin 20 mL
Purified water qs 100mL
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.
3. Mix the naltrexone, ascorbic acid, and sodium benzoate together and pulverize to a fine powder.
4. Add the glycerin and mix to form a smooth paste.
5. Add the purified water geometrically to volume and mix well.
6. Package and label.
PACKAGING
Package in tight, light-resistant containers.1
LABELING
Keep out of reach of children. Use only as directed.
STABILITY
If prepared from tablets, a beyond-use date of 90 days in the refrigerator or at room temperature can be used for this preparation. If prepared from the powder, a beyond-use date of 90 days in the refrigerator or 60 days at room temperature can be used for this preparation.2
USE
Naltrexone oral liquid is used in the management of opiate and alcohol dependence.
QUALITY CONTROL
Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, clarity, rheological properties/pour-ability, physical observation, and physical stability (discoloration, foreign materials,...