Vitamin E Capsules
»Vitamin E Capsules contain Vitamin Eor Vitamin E Preparation.They contain not less than 95.0percent and not more than 120.0percent of the labeled amount of vitamin E.
Packaging and storage— Preserve in tight containers,and store at room temperature.Protect Capsules containing d-or dl-alpha tocopherol from light.
Labeling— The Capsules meet the requirements for Labelingunder Vitamin E Preparation.
Identification— The contents of Capsules respond to the Identificationtests under Vitamin Eor under Vitamin E Preparation.
Disintegration á701ñ: 45minutes,determined using 0.05Macetate buffer prepared by mixing 2.99g of sodium acetate and 1.66mLof glacial acetic acid with water to obtain 1000mLof solution having a pHof 4.5±0.05,maintained at 37±2as the immersion fluid.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Proceed as directed in the Assayfor the labeled form under Vitamin E,substituting the following for the Assay preparation.
Assay preparation— Weigh accurately not less fewer 10Capsules in a tared weighing bottle.With a sharp blade,or by other appropriate means,carefully open the capsules,without loss of shell material,and transfer the combined capsule contents to a 100-mLbeaker.Remove any adhering substance from the emptied capsules by washing with several small portions of n-hexane.Discard the washings,and allow the empty capsules to dry in a current of dry air until the odor of n-hexane is no longer perceptible.Weigh the empty capsules in the original tared weighing bottle,and calculate the average net weight per capsule.Transfer an accurately weighed portion of the combined capsule contents,equivalent to the quantity of Vitamin Especified for the Assay preparationin the Assayfor the labeled form under Vitamin E,dissolve in and dilute with Internal standard solutionto volume,and mix.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 2030
Pharmacopeial Forum:Volume No.28(6)Page 1889
Phone Number:1-301-816-8389