Vitamin E Capsules
» Vitamin E Capsules contain Vitamin E or Vitamin E Preparation. They contain not less than 95.0 percent and not more than 120.0 percent 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 Labeling under Vitamin E Preparation.
USP Reference standards 11
USP Alpha Tocopherol RS.
USP Alpha Tocopheryl Acetate RS.
USP Alpha Tocopheryl Acid Succinate RS.
Identification The contents of Capsules respond to the Identification tests under Vitamin E or under Vitamin E Preparation.
Disintegration 701: 45 minutes, determined using 0.05 M acetate buffer prepared by mixing 2.99 g of sodium acetate and 1.66 mL of glacial acetic acid with water to obtain 1000 mL of solution having a pH of 4.5 ± 0.05, maintained at 37 ± 2 as the immersion fluid.
Uniformity of dosage units 905: meet the requirements.
Assay Proceed as directed in the Assay for the labeled form under Vitamin E, substituting the following for the Assay preparation.
Assay preparation Weigh accurately not fewer 10 Capsules 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-mL beaker. 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 E specified for the Assay preparation in the Assay for the labeled form under Vitamin E, dissolve in and dilute with Internal standard solution to volume, and mix.
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USP32NF27 Page 3867Pharmacopeial Forum: Volume No. 28(6) Page 1889