Packaging and storage— Preserve in tight,light-resistant containers.

USP Reference standards á11ñ— USP Meperidine Hydrochloride RS.

Identification— Transfer a volume of Syrup,equivalent to about 100mg of meperidine hydrochloride,to a 125-mLseparator,add 40mLof water and 3mLof 1Nsodium hydroxide,and extract with three 25-mLportions of n-hexane.Wash the combined extracts with two 20-mLportions of water,discard the water,and then extract with three 25-mLportions of 0.1Nhydrochloric acid.Transfer the extracts to a 100-mLvolumetric flask,dilute with 0.1Nhydrochloric acid to volume,and mix:the UVabsorption spectrum of this solution exhibits maxima and minima at the same wavelengths as that of a similar preparation of USP Meperidine Hydrochloride RS,concomitantly measured.

Uniformity of dosage units á905ñ—

Deliverable volume á698ñ—

pHá791ñ: between 3.5and 4.1.

Assay— Transfer an accurately measured volume of Syrup,equivalent to about 250mg of meperidine hydrochloride,to a separator,and add 3mLof 1Nsodium hydroxide.Extract with five 20-mLportions of chloroform,and filter the extracts through a pledget of cotton into a 250-mLconical flask.Wash the cotton with 5mLof chloroform,and add the washing to the combined filtrates.Add 10mLof glacial acetic acid and 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 28.38mg of C15H21NO2·HCl.

Expert Committee:(PA2)Pharmaceutical Analysis 2

USP28–NF23Page 1209

Phone Number:1-301-816-8143