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

USP Reference standards á11ñ— USP Meclofenamate Sodium RS.

Identification— Prepare a solution of Capsule contents in methanol containing 20mg per mL,and filter.The clear filtrate so obtained meets the requirements of the Thin-Layer Chromatographic Identification Test á201ñ,the solvent mixture consisting of methylene chloride,methyl ethyl ketone,and glacial acetic acid (50:48:2).

Dissolution á711ñ—

Uniformity of dosage units á905ñ: meet the requirements.

Assay— Remove,as completely as possible,the contents of not fewer than 20Capsules,and weigh accurately.Mix the combined contents,and transfer an accurately weighed quantity of the powder,equivalent to about 50mg of meclofenamic acid,to a 200-mLvolumetric flask.Add 0.01Nhydrochloric acid in methanol to volume,and mix.Filter,discarding the first 20mLof the filtrate.Transfer 10.0mLof the filtrate to a 100-mLvolumetric flask,add 0.01Nhydrochloric acid in methanol to volume,and mix.Dissolve an accurately weighed quantity of USP Meclofenamate Sodium RSin 0.01Nhydrochloric acid in methanol to obtain a solution having a known concentration of about 27µg per mL.Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 336nm,with a suitable spectrophotometer,using 0.01Nhydrochloric acid in methanol as the blank.Calculate the quantity,in mg,of meclfenamate acid (C14H11Cl2NO2)in the portion of Capsule contents taken by the formula: in which Cis the concentration,in µg per mL,of USP Meclofenamate Sodium RSin the Standard solution;296.15and 318.13are the molecular weights of meclofenamic acid and meclofenamate sodium,respectively;and AUand ASare the absorbances of the solution from the Capsule contents and the Standard solution,respectively.

Expert Committee:(PA2)Pharmaceutical Analysis 2

USP28–NF23Page 1196

Phone Number:1-301-816-8143