![]() 3,4 Note: The vehicle in this formula contains preservatives and is slightly acidic.ĭiscussion: Amlodipine besylate (Norvasc, C 20H 25ClN 2O 5.C 6H 6O 3S, MW 567.05) occurs as a white or almost-white powder that is sparingly soluble in alcohol and in water. Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic properties/pourability, physical observation, physical stability (discoloration, foreign materials, gas formation, mold growth), and preservative-effectiveness test. When packaged in PreciseDose Dispenser amber syringes, a beyond-use date of 90 days at refrigerated temperature or 45 days at room temperature may be used when prepared with the exact ingredients listed and according to the procedures provided based on stability studies performed by Medisca. Stability: When packaged in amber glass bottles, a beyond-use date of 90 days at refrigerated temperature or 60 days at room temperature may be used for this preparation when compounded with the exact ingredients listed and according to the procedures provided. Packaging: Package in tight, light-resistant amber glass containers or in PreciseDose Dispenser amber syringes. Use: Amlodipine is used as an antihypertensive and antianginal. Note: Stability data are provided for two different types of dispensing containers. Transfer to an appropriate dispensing container or dosing syringes as described in the Stability section package and label. Incrementally, add 50 mL of the Oral Mix flavored suspending vehicle, mixing well after each addition. Add 5 mL of the Oral Mix flavored suspending vehicle and mix to form a smooth paste. Pulverize the tablets to a very fine powder. Accurately weigh or measure each ingredient. Method of Preparation: Calculate the required quantity of each ingredient for the total amount to be prepared.
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