Printed on: Tue Nov 07 2023, 12:10:03 PM(EST) Status: Currently Official on 07-Nov-2023 DocId: GUID-EB7089DD-63BF-49A4-8B4D-AB64510C02FF_2_en-US

Printed by: Debashish Bose Official Date: Official as of 01-May-2020 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: 6nb3r DOI: https://doi.org/10.31003/USPNF_M51220_02_01
1

rS = peak response of methocarbamol from the

Methocarbamol Tablets Standard solution
DEFINITION CS = concentration of USP Methocarbamol RS in the
Methocarbamol Tablets contain NLT 95.0% and NMT 105.0% Standard solution (mg/mL)
of the labeled amount of methocarbamol (C11H15NO5). CU = nominal concentration of methocarbamol in the
Sample solution (mg/mL)
IDENTIFICATION
Acceptance criteria: 95.0%–105.0%
Change to read:
PERFORMANCE TESTS
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared • DISSOLUTION á711ñ
Spectroscopy: 197K▲ (CN 1-May-2020) Medium: Water; 900 mL
Sample: Mix a portion of finely powdered Tablets Apparatus 2: 50 rpm
equivalent to 1 g of methocarbamol with 25 mL of water Time: 45 min
in a separator, and extract with 25 mL of chloroform. Filter Mobile phase, Chromatographic system, and System
the extract, and evaporate to dryness. suitability: Proceed as directed in the Assay.
Acceptance criteria: Meet the requirements Standard solution: USP Methocarbamol RS in Medium
• B. The retention time of the major peak of the Sample Sample solution: Filtered portion of the solution under test,
solution corresponds to that of the Standard solution, as diluted with Medium if necessary
obtained in the Assay. Analysis
Samples: Standard solution and Sample solution
ASSAY Calculate the percentage of the labeled amount of
• PROCEDURE methocarbamol (C11H15NO5) dissolved:

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Buffer: 6.8 g/L of monobasic potassium phosphate in water.
Adjust with phosphoric acid or sodium hydroxide to a pH Result = (rU/rS) × CS × V × (1/L) × 100
of 4.5.
Mobile phase: Methanol and Buffer (30:70) rU = peak response of methocarbamol from the
System suitability solution: 1.0 mg/mL of USP Sample solution
Methocarbamol RS and 0.005 mg/mL of USP
Guaifenesin RS in Mobile phase
Standard solution: 0.1 mg/mL of USP Methocarbamol RS
in Mobile phase
ci rS

CS
= peak response of methocarbamol from the
Standard solution
= concentration of USP Methocarbamol RS in the
Standard solution (mg/mL)
Sample stock solution: Nominally 1 mg/mL of V = volume of Medium, 900 mL
methocarbamol solution prepared as follows. Transfer a L = label claim for methocarbamol (mg/Tablet)
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portion of finely powdered Tablets (NLT 10) to a volumetric
flask of suitable size. Add 60% of the volume of the flask Tolerances: NLT 75% (Q) of the labeled amount of
with Mobile phase. Sonicate for 30 min with intermittent methocarbamol (C11H15NO5) is dissolved.
shaking. Dilute with Mobile phase to volume. Pass a portion • UNIFORMITY OF DOSAGE UNITS á905ñ: Meet the
of the solution through a suitable filter of 0.45-µm pore size. requirements
Sample solution: Nominally 0.1 mg/mL of methocarbamol
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from the Sample stock solution in Mobile phase IMPURITIES

Chromatographic system • ORGANIC IMPURITIES
(See Chromatography á621ñ, System Suitability.) Mobile phase, System suitability solution, and
Mode: LC Chromatographic system: Proceed as directed in the
Detector: UV 274 nm Assay.
Column: 4.6-mm × 15-cm; 3-µm packing L1 Standard solution: 0.005 mg/mL of USP
Column temperature: 30° Methocarbamol RS in Mobile phase
Flow rate: 0.8 mL/min Sample solution: Use the Sample stock solution from the
Injection volume: 20 µL Assay.
Run time: 1.5 times the retention time of methocarbamol System suitability
System suitability Samples: System suitability solution and Standard solution
Samples: System suitability solution and Standard solution [NOTE—See Table 1 for relative retention times.]
[NOTE—See Table 1 for relative retention times.] Suitability requirements
Suitability requirements Resolution: NLT 3.5 between methocarbamol and
Resolution: NLT 3.5 between methocarbamol and guaifenesin, System suitability solution
guaifenesin, System suitability solution Tailing factor: NMT 2.0, Standard solution
Tailing factor: NMT 2.0, Standard solution Relative standard deviation: NMT 5.0%, Standard
Relative standard deviation: NMT 2.0%, Standard solution
solution Analysis
Analysis Samples: Standard solution and Sample solution
Samples: Standard solution and Sample solution Calculate the percentage of each degradation product in
Calculate the percentage of the labeled amount of the portion of Tablets taken:
methocarbamol (C11H15NO5) in the portion of Tablets
taken: Result = (rU/rS) × (CS/CU) × (1/F) × 100

Result = (rU/rS) × (CS/CU) × 100 rU = peak response of each degradation product

from the Sample solution
rU = peak response of methocarbamol from the rS = peak response of methocarbamol from the
Sample solution Standard solution

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Printed on: Tue Nov 07 2023, 12:10:03 PM(EST) Status: Currently Official on 07-Nov-2023 DocId: GUID-EB7089DD-63BF-49A4-8B4D-AB64510C02FF_2_en-US
Printed by: Debashish Bose Official Date: Official as of 01-May-2020 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: 6nb3r DOI: https://doi.org/10.31003/USPNF_M51220_02_01
2

CS = concentration of USP Methocarbamol RS in the Table 1 (continued)

Standard solution (mg/mL) Relative Relative Acceptance
CU = nominal concentration of methocarbamol in the Retention Response Criteria,
Sample solution (mg/mL) Name Time Factor NMT (%)
F = relative response factor (see Table 1) Any individual
unspecified — —
Acceptance criteria: See Table 1. degradation product 0.10

Total impurities — — 1.0

Table 1
a 1-Hydroxy-3-(2-methoxyphenoxy)propan-2-yl carbamate.
Relative Relative Acceptance
Retention Response Criteria, b 4-[(2-Methoxyphenoxy)methyl]-1,3-dioxolan-2-one.
Name Time Factor NMT (%)
Guaifenesin 0.84 1.2 0.15 ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight containers.
Methocarbamol iso- Store at controlled room temperature.
mera 0.90 1.0 0.05
• USP REFERENCE STANDARDS á11ñ
Methocarbamol 1.0 — — USP Guaifenesin RS
Methocarbamol diox-
USP Methocarbamol RS
oloneb 1.3 1.0 0.05

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