Tetracycline Hydrochloride Oral Suspension »Tetracycline Hydrochloride Oral Suspension contains not less than 2.25g and not more than 2.75g of Tetracycline Hydrochloride in 100mLof Oral Suspension. Prepare Tetracycline Hydrochloride Oral Suspension as follows (see Pharmaceutical Compounding—Nonsterile Preparations á795ñ): Tetracycline Hydrochloride 2.50g Cetylpyridinium Chloride 10mg Xanthan Gum 0.15g Disbasic Sodium Phosphate 60mg Monobasic Sodium Phosphate 0.65g Sodium Hydroxide 0.30g Purified Water 35mL Suspension Structured Vehicle or Sugar-
Free Suspension Structured Vehicle,a
sufficient quantity,to make 100mL Dissolve the Dibasic Sodium Phosphate and the Monobasic Sodium Phosphate in 25mLof 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 5mLof a solution containing 10mg of Cetylpyridinium Chloride.Mix this solution with 5mLof 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 20mLof 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 20mLof the Suspension Structured Vehicle or Sugar-Free Suspension Vehicle to the mixture. Dissolve the Sodium Hydroxide in 5mLof 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 100mL,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. pHá791ñ: between 3.5and 6.0. Beyond-use date— Thirty days after the day on which it was compounded. Assay— Diluting solvent,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in theAssay underTetracycline Hydrochloride. Assay preparation— Transfer an accurately measured volume of Oral Suspension,equivalent to about 125mg of tetracycline hydrochloride,to a 250-mLvolumetric flask,add 200mLofDiluting solvent,and shake.AddDiluting solvent to volume,mix,and filter. Procedure— Proceed as directed in theAssay underTetracycline 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 whichVis the volume,in mL,of Oral Suspension taken;and the other terms are as defined therein. Auxiliary Information— Staff Liaison:Claudia C.Okeke,Ph.D.,Associate Director Expert Committee:(CRX)Compounding Pharmacy USP28–NF23Page 1889 Pharmacopeial Forum:Volume No.28(2)Page 378 Phone Number:1-301-816-8243