» Tetracycline Hydrochloride Oral Suspension contains not less than 2.25 g and not more than 2.75 g of Tetracycline Hydrochloride in 100 mL of Oral Suspension.

Prepare Tetracycline Hydrochloride Oral Suspension as follows (see Pharmaceutical Compounding—Nonsterile Preparations 795):

Dissolve the Dibasic Sodium Phosphate and the Monobasic Sodium Phosphate in 25 mL of Purified Water. Separately dissolve an accurately weighed quantity of Cetylpyridinium Chloride in Purified Water and dilute quantitatively, and stepwise if necessary, with Purified Water to obtain 5 mL of a solution containing 10 mg of Cetylpyridinium Chloride. Mix this solution with 5 mL of the aqueous phosphate solution and add the resulting solution, in divided portions, with mixing, to the Tetracycline Hydrochloride in a glass mortar to completely wet the powder, and make a smooth paste.

Transfer the remaining 20 mL of the aqueous phosphate solution to a beaker. Using moderate heat, stir to form a vortex, and slowly sprinkle the Xanthan Gum into the vortex to produce a uniform dispersion. Add this dispersion to the paste in the glass mortar, and mix until smooth; then add 20 mL of the Suspension Structured Vehicle or Sugar-Free Suspension Vehicle to the mixture.

Dissolve the Sodium Hydroxide in 5 mL of Purified Water, and while mixing, slowly add this solution to the prepared mixture. Complete the suspension by adding a sufficient quantity of the Suspension Structured Vehicle or Sugar-Free Suspension Vehicle to make a final volume of 100 mL, and pass this final dispersion through a hand homogenizer prior to transferring it to the dispensing container.