Meclofenamate Sodium Capsules
» Meclofenamate Sodium Capsules contain an amount of C14H10Cl2NNaO2 equivalent to not less than 90.0 percent and not more than 110.0 percent of the labeled amount of meclofenamic acid (C14H11Cl2NO2).
Packaging and storage— Preserve in tight, light-resistant containers.
USP Reference standards 11
USP Meclofenamate Sodium RS Click to View Structure
Identification— Prepare a solution of Capsule contents in methanol containing 20 mg per mL, and filter. The clear filtrate so obtained meets the requirements of the Thin-Layer Chromatographic Identification Test 201, the solvent mixture consisting of methylene chloride, methyl ethyl ketone, and glacial acetic acid (50:48:2).
Dissolution 711
Medium: 0.05 M pH 7.5 phosphate buffer (see under Buffer Solutions in the section Reagents, Indicators, and Solutions); 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure— Determine the amount of meclofenamic acid (C14H11Cl2NO2) dissolved from UV absorbances at the wavelength of maximum absorbance at about 279 nm of filtered portions of the solution under test, suitably diluted with Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Meclofenamate Sodium RS in the same Medium.
Tolerances— Not less than 75% (Q) of the labeled amount of C14H11Cl2NO2 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay— Remove, as completely as possible, the contents of not fewer than 20 Capsules, and weigh accurately. Mix the combined contents, and transfer an accurately weighed quantity of the powder, equivalent to about 50 mg of meclofenamic acid, to a 200-mL volumetric flask. Add 0.01 N hydrochloric acid in methanol to volume, and mix. Filter, discarding the first 20 mL of the filtrate. Transfer 10.0 mL of the filtrate to a 100-mL volumetric flask, add 0.01 N hydrochloric acid in methanol to volume, and mix. Dissolve an accurately weighed quantity of USP Meclofenamate Sodium RS in 0.01 N hydrochloric acid in methanol to obtain a solution having a known concentration of about 27 µg per mL. Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 336 nm, with a suitable spectrophotometer, using 0.01 N hydrochloric 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:
2C(296.15 / 318.13)(AU / AS)
in which C is the concentration, in µg per mL, of USP Meclofenamate Sodium RS in the Standard solution; 296.15 and 318.13 are the molecular weights of meclofenamic acid and meclofenamate sodium, respectively; and AU and AS are the absorbances of the solution from the Capsule contents and the Standard solution, respectively.
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Monograph Clydewyn M. Anthony, Ph.D.
Senior Scientific Liaison
1-301-816-8139
(SM22010) Monographs - Small Molecules 2
Reference Standards RS Technical Services
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711 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
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(GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 3779