Tetracycline Hydrochloride Oral Suspension
» 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):
Tetracycline Hydrochloride 2.50 g
Cetylpyridinium Chloride 10 mg
Xanthan Gum 0.15 g
Disbasic Sodium Phosphate 60 mg
Monobasic Sodium Phosphate 0.65 g
Sodium Hydroxide 0.30 g
Purified Water 35 mL
Suspension Structured Vehicle or Sugar-Free Suspension Structured Vehicle, a sufficient quantity to make 100 mL
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.
Packaging and storage— Preserve in tight, light-resistant containers. Store at controlled room temperature, and protect from freezing.
Labeling— Label it to state that it should not be frozen and that it is to be well shaken before using.
pH 791: between 3.5 and 6.0.
Beyond-use date— Thirty days after the day on which it was compounded.
Diluting solvent, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Prepare as directed in the Assay under Tetracycline Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Oral Suspension, equivalent to about 125 mg of tetracycline hydrochloride, to a 250-mL volumetric flask, add 200 mL of Diluting solvent, and shake. Add Diluting solvent to volume, mix, and filter.
Procedure— Proceed as directed in the Assay under Tetracycline Hydrochloride. Calculate the quantity, in mg per mL, of tetracycline hydrochloride (C22H24N2O8·HCl) in the Oral Suspension taken by the formula:
(CP/4V)(rU / rS)
in which V is the volume, in mL, of Oral Suspension taken; and the other terms are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Rick G. Schnatz
Manager, Compounding Pharmacy Expert Committee
(CRX05) Compounding Pharmacy05
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3699
Pharmacopeial Forum: Volume No. 28(2) Page 378