Thiamine Hydrochloride Tablets, chemical structure, molecular formula, Reference Standards
Thiamine Hydrochloride Tablets
»Thiamine Hydrochloride Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C12H17ClN4OS·HCl.
Packaging and storage
Preserve in tight,light-resistant containers.
USP Reference standards á11ñ
USP Thiamine Hydrochloride RS.
Triturate a quantity of powdered Tablets,equivalent to about 10mg of thiamine hydrochloride,with 10mLof 0.5Nsodium hydroxide,and filter.Using a 5-mLportion of the filtrate,proceed as directed in Identificationtest Bunder Thiamine Hydrochloride Injection,beginning with then add 0.5mLof potassium ferricyanide TS:the specified reaction is observed.
Triturate a quantity of powdered Tablets,equivalent to about 10mg of thiamine hydrochloride,with 10mLof water,and filter:treated separately,2-mLportions of the filtrate yield a red-brown precipitate with iodine TSand a white precipitate with mercuric chloride TS,and respond to the tests for Chloride á191ñ.
To the remainder of the filtrate prepared for the preceding test add 1mLof lead acetate TSand 1mLof 2.5Nsodium hydroxide:a yellow color is produced.Heat the mixture for several minutes on a steam bath:the color changes to brown,and,on standing,a precipitate of lead sulfide separates.
Dissolution,Procedure for a Pooled Sample á711ñ
Determine the amount of C12H17ClN4OS·HCl dissolved,employing the procedure set forth in the Assay for niacin or niacinamide,pyridoxine hydrochloride,riboflavin,and thiamineunder Water-Soluble Vitamins Tabletsusing filtered portions of the solution under test,suitably diluted with Dissolution Mediumif necessary,in comparison with a Standard solution having a known concentration of USP Thiamine Hydrochloride RSin the same Medium.
Not less than 75%(Q)of the labeled amount of C12H17ClN4OS·HCl is dissolved in 45minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Prepare as directed for Standard Preparationunder Thiamine Assay á531ñ.
Place not fewer than 20Tablets in a flask of suitable size,half fill the flask with 0.2Nhydrochloric acid,and heat on a steam bath,with frequent agitation,until the tablets have dissolved or have disintegrated so that a uniform dispersion is obtained.Cool,transfer the contents of the flask to a volumetric flask,and dilute with 0.2Nhydrochloric acid to volume.If the mixture is not clear,either centrifuge it or filter it through paper known not to adsorb thiamine.Dilute a portion of the clear solution quantitatively and stepwise with 0.2Nhydrochloric acid to obtain a solution containing about 0.2µg of thiamine hydrochloride per mL.Using this as the Assay Preparation,proceed as directed for Procedureunder Thiamine Assay á531ñ.
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
Pharmacopeial Forum:Volume No.30(1)Page 190
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