Pyridoxine Hydrochloride Tablets, chemical structure, molecular formula, Reference Standards

Pyridoxine Hydrochloride Tablets

»Pyridoxine Hydrochloride Tablets contain not less than 95.0percent and not more than 115.0percent of the labeled amount of C8H11NO3·HCl.

Packaging and storage— Preserve in well-closed containers,protected from light.

USP Reference standards á11ñ— USP Pyridoxine Hydrochloride RS.

Identification— To a quantity of powdered Tablets,equivalent to about 100mg of pyridoxine hydrochloride,add about 5mLof water.Shake the mixture,filter into a test tube,and add 2or 3drops of ferric chloride TS:an orange to deep red color is produced.

Dissolution,Procedure for a Pooled Sample á711ñ—

Medium: water;900mL.

Apparatus 2: 50rpm.

Time: 45minutes.

Procedure— Determine the amount of C8H11NO3·HCl dissolved employing the procedure set forth in the Assay for niacin or niacinamide,pyridoxine hydrochloride,riboflavin,and thiamineunder Water-Soluble Vitamins Tabletsby using filtered portions of the solution under test suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Pyridoxine Hydrochloride RSin the same medium.

Tolerances— Not less than 75%(Q)of the labeled amount of C8H11NO3·HCl is dissolved in 45minutes.

Uniformity of dosage units á905ñ: meet the requirements.

Procedure for content uniformity— Transfer 1Tablet,previously finely powdered,to a 500-mLvolumetric flask containing about 300mLof water,shake for about 30minutes,and dilute with water to volume.Filter a portion of the mixture,discarding the first 25mLof the filtrate.Dilute a suitable aliquot of the subsequent filtrate quantitatively and stepwise with dilute hydrochloric acid (1in 100)so that the concentration of pyridoxine hydrochloride is about 10µg per mL.Dissolve an accurately weighed quantity of USP Pyridoxine Hydrochloride RSin dilute hydrochloric acid (1in 100),and dilute quantitatively and stepwise with the same solvent to obtain a Standard solution having a known concentration of about 10µg per mL.Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 290nm,with a suitable spectrophotometer,using dilute hydrochloric acid (1in 100)as the blank.Calculate the quantity,in mg,of C8H11NO3·HCl in the Tablet taken by the formula:

(T/D)C(AU/AS),

in which Tis the labeled quantity,in mg,of pyridoxine hydrochloride in the Tablet,Dis the dilution factor,Cis the concentration,in µg per mL,of USP Pyridoxine Hydrochloride RSin the Standard solution,and AUand ASare the absorbances of the solution from the Tablet and the Standard solution,respectively.

Assay— Weigh and finely powder not less than 20Tablets.Weigh accurately a portion of the powder,equivalent to about 10mg of pyridoxine hydrochloride,and transfer,with the aid of water,to a conical flask.Add 5mLof hydrochloric acid,then dilute with water to about 250mL,and heat on a steam bath until disintegration is complete.Cool,transfer to a 1000-mLvolumetric flask,dilute with water to volume,mix,and centrifuge a portion of the mixture.Using the clear supernatant as the Assay preparation,proceed as directed in the Assayunder Pyridoxine Hydrochloride Injection,calculating the quantity,in mg,of C8H11NO3·HCl in the portion of Tablets taken by the formula:

C(AU-AU¢)/(AS-AS¢),

in which Cis the concentration,in µg per mL,of USP Pyridoxine Hydrochloride RSin the Standard preparation,and the other terms are as defined therein.

Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist

Expert Committee:(DSN)Dietary Supplements:Non-Botanicals

USP28–NF23Page 1684

Pharmacopeial Forum:Volume No.30(1)Page 177

Phone Number:1-301-816-8389