Promazine Hydrochloride Tablets
»Promazine Hydrochloride Tablets contain not less than 95.0percent and not more than 110.0percent of the labeled amount of C17H20N2S·HCl.
Packaging and storage— Preserve in tight,light-resistant containers.
USP Reference standards á11ñ— USP Promazine Hydrochloride RS.
NOTE—Throughout the following procedures,protect test or assay specimens,the Reference Standard,and solutions containing them,by conducting the procedures without delay,under subdued light,or using low-actinic glassware.
Identification—
A: Shake a portion of powdered Tablets,equivalent to about 50mg of promazine hydrochloride,with 25mLof 0.01Nhydrochloric acid for 5minutes,and filter:the solution meets the requirements under Identification—Organic Nitrogenous Bases á181ñ.
B: It responds to Identificationtest Bunder Promazine Hydrochloride.
Disintegration á701ñ: 30minutes,with disks.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— [NOTE—Use low-actinic glassware.]Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 50mg of promazine hydrochloride,to a 100-mLvolumetric flask.Add 50mLof 0.1Nhydrochloric acid,and shake by mechanical means for about 1hour.Dilute with 0.1Nhydrochloric acid to volume,mix,and centrifuge a portion of the mixture.Transfer 10.0mLof the clear,supernatant to a 250-mLseparator,and proceed as directed in the Assayunder Promazine Hydrochloride Injection,beginning with “add 20mLof water.”Calculate the quantity,in mg,of C17H20N2S·HCl in the portion of Tablets taken by the formula:
C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Promazine Hydrochloride RSin the Standard solution,and AUand ASare the absorbances of the solution from the Tablets and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1640
Phone Number:1-301-816-8379