Albendazole
C12H15N3O2S 265.33
Carbamic acid, [5-(propylthio)-1H-benzimidazol-2-yl]-, methyl ester;
Methyl 5-(propylthio)-2-benzimidazolecarbamate
[54965-21-8].
(al ben' da zole).
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C12H15N3O2S 265.33
Carbamic acid, [5-(propylthio)-1H-benzimidazol-2-yl]-, methyl ester;
Methyl 5-(propylthio)-2-benzimidazolecarbamate
[54965-21-8].DEFINITION
Albendazole contains NLT 98.0% and NMT 102.0% of albendazole (C12H15N3O2S), calculated on the dried basis.
IDENTIFICATION
• B.
The RF value of the principal spot of the Sample solution corresponds to that of the principal spot of the Standard solution, as obtained in the test for Organic Impurities.
ASSAY
• Procedure
Sample:
250 mg of Albendazole
Analysis:
Transfer the Sample to a suitable flask, and dissolve in 100 mL of glacial acetic acid, warming gently if necessary. Cool, and titrate with 0.1 N perchloric acid VS to a potentiometric endpoint (see Titrimetry 
541
). Perform a blank determination. Each mL of 0.1 N perchloric acid is equivalent to 26.53 mg of C12H15N3O2S.
541). Perform a blank determination. Each mL of 0.1 N perchloric acid is equivalent to 26.53 mg of C12H15N3O2S.
Acceptance criteria:
98.0%–102.0% on the dried basis
IMPURITIES
• Residue on Ignition 281:
NMT 0.2%
281:
NMT 0.2%
• Organic Impurities
Standard stock solution:
5 mg/mL of USP Albendazole RS in glacial acetic acid
Standard solution:
0.05 mg/mL of USP Albendazole RS in glacial acetic acid from Standard stock solution
Sample solution:
10 mg/mL in glacial acetic acid
Chromatographic system
Mode:
TLC
Adsorbant:
0.25-mm layer of silica gel mixture
Application volume:
10 µL
Developing solvent system:
Chloroform, ether, and glacial acetic acid (60:10:10)
Analysis:
Proceed as directed for Chromatography 621, Thin-Layer Chromatography.
621, Thin-Layer Chromatography.
Samples:
Standard stock solution, Standard solution, and Sample solution
Develop the chromatogram in the Developing solvent system until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, allow the solvent to evaporate from the plate, and examine the plate under short-wavelength UV light.
Acceptance criteria:
0.5%; no spot, other than the principal spot of the Sample solution, is larger or more intense than the principal spot of the Standard solution.
SPECIFIC TESTS
for 4 h.ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers, and store at controlled room temperature.
• USP Reference Standards 11
11
USP Albendazole RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Morgan Puderbaugh
Scientific Liaison (301) 998-6833 |
(SM32010) Monographs - Small Molecules 3 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 2065
Pharmacopeial Forum: Volume No. 34(1) Page 69