Methocarbamol Tablets
» Methocarbamol Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of methocarbamol (C11H15NO5).
Packaging and storage— Preserve in tight containers.
Identification— Mix a portion of finely powdered Tablets, equivalent to about 1 g of methocarbamol, with 25 mL of water in a separator, and extract with 25 mL of chloroform. Filter the extract, and evaporate to dryness: the residue of methocarbamol so obtained responds to Identification test A under Methocarbamol.
Dissolution, Procedure for a Pooled Sample 711
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure— Determine the amount of C11H15NO5 dissolved, employing the procedure set forth in the Assay, making any necessary modifications.
Tolerances— Not less than 75% (Q) of the labeled amount of C11H15NO5 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay—
pH 4.5 Buffer solution, Mobile phase, and Chromatographic system— Proceed as directed in the Assay under Methocarbamol Injection.
Internal standard solution— Prepare a solution of caffeine in methanol containing about 3 mg per mL.
Standard preparation— Transfer about 100 mg of USP Methocarbamol RS, accurately weighed, to a 100-mL volumetric flask. Dissolve in about 50 mL of pH 4.5 Buffer solution and 25 mL of methanol. Add 5.0 mL of Internal standard solution, dilute with pH 4.5 Buffer solution to volume, and mix.
Assay preparation— Weigh and powder not less than 10 Tablets. Transfer an accurately weighed portion of the powder, equivalent to 100 mg of methocarbamol, to a 100-mL volumetric flask. Add about 50 mL of pH 4.5 Buffer solution, 25 mL of methanol, and 5.0 mL of Internal standard solution. Shake vigorously for 10 minutes, dilute with pH 4.5 Buffer solution to volume, and mix. Filter, discarding the first 20 mL of the filtrate.
Procedure— Proceed as directed for Procedure in the Assay under Methocarbamol Injection. Calculate the quantity, in mg, of methocarbamol (C11H15NO5) in the portion of Tablets taken by the formula:
100C(RU / RS)
in which C is the concentration, in mg per mL, of USP Methocarbamol RS in the Standard preparation; and RU and RS are the peak response ratios of methocarbamol and caffeine obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
1-301-816-8330
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
1-301-816-8106
(BPC05) Biopharmaceutics05
USP32–NF27 Page 2926
Pharmacopeial Forum: Volume No. 30(1) Page 130
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.