U.S. PHARMACOPEIA

Search USP29  
Alpha Lipoic Acid Tablets
» Alpha Lipoic Acid Tablets contain not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C8H14O2S2.
Packaging and storage— Preserve in well-closed containers.
Labeling— Tablets that are coated are so labeled.
Identification— The retention time of the major peak in the chromatogram of the Test solution corresponds to that in the chromatogram of the Standard solution, as obtained in the test for Content of alpha lipoic acid.
Disintegration and dissolution 2040—
Medium: water; 900 mL.
Apparatus 2: 75 rpm.
Time: 60 minutes.
Determine the amount of C8H14O2S2 dissolved by employing the following method.
Mobile phase, Standard solution, Test solution, Chromatographic system, and Procedure— Proceed as directed for Disintegration and dissolution 2040 under Alpha Lipoic Acid Capsules.
Tolerances— Not less than 70% of the labeled amount of C8H14O2S2 is dissolved in 60 minutes.
Weight variation 2091: meet the requirements.
Content of alpha lipoic acid—
Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed for the test for Content of alpha lipoic acid under Alpha Lipoic Acid Capsules.
Test solution— Proceed as directed for Test solution 1 (for hard gelatin capsules) in the test for Content of alpha lipoic acid under Alpha Lipoic Acid Capsules, except to use not fewer than 20 Tablets.
Procedure— Proceed as directed in the test for Content of alpha lipoic acid under Alpha Lipoic Acid Capsules. Calculate the quantity, in mg, of alpha lipoic acid in the portion of Tablets taken by the formula:
2000C(rU / rS),
in which C, rU, and rS are as defined therein.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 2353
Pharmacopeial Forum : Volume No. 27(6) Page 3414
Phone Number : 1-301-816-8389