Alpha Lipoic Acid Tablets, chemical structure, molecular formula, Reference Standards

Alpha Lipoic Acid Tablets

»Alpha Lipoic Acid Tablets contain not less than 90.0percent and not more than 115.0percent of the labeled amount of C8H14O2S2.

Packaging and storage— Preserve in well-closed containers.

Labeling— Tablets that are coated are so labeled.

USP Reference standards á11ñ— USP Alpha Lipoic Acid RS.

Identification— The retention time of the major peak in the chromatogram of theTest solution corresponds to that in the chromatogram of theStandard solution,as obtained in the test forContent of alpha lipoic acid.

Disintegration and dissolution á2040ñ—

Medium: water;900mL.

Apparatus 2: 75rpm.

Time: 60minutes.

Determine the amount of C8H14O2S2dissolved by employing the following method.

Mobile phase,Standard solution,Test solution,Chromatographic system,and Procedure— Proceed as directed for Disintegration and dissolution á2040ñunderAlpha Lipoic Acid Capsules.

Tolerances— Not less than 70%of the labeled amount of C8H14O2S2is dissolved in 60minutes.

Weight variation á2091ñ: meet the requirements.

Content of alpha lipoic acid—

Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed for the test forContent of alpha lipoic acid underAlpha Lipoic Acid Capsules.

Test solution— Proceed as directed forTest solution 1(for hard gelatin capsules)in the test forContent of alpha lipoic acid underAlpha Lipoic Acid Capsules,except to use not fewer than 20Tablets.

Procedure— Proceed as directed in the test forContent of alpha lipoic acid underAlpha 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 whichC,rU,and rSare as defined therein.

Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist

Expert Committee:(DSN)Dietary Supplements:Non-Botanicals

USP28–NF23Page 2111

Pharmacopeial Forum:Volume No.27(6)Page 3414

Phone Number:1-301-816-8389