Basket-Rack Assembly— The basket-rack assembly consists of three open-ended transparent tubes,each 7.95-±0.05-cm long and having an inside diameter of approximately 33.3-mm and a wall approximately 2.4mm thick;the tubes are held in a vertical position by two plastic plates,each about 9.7cm in diameter and 9.5mm in thickness,with three holes,each about 39mm in diameter,equidistant from the center of the plate and equally spaced from one another.Attached to the under surface of the lower plate is 10-mesh No.23(0.025-inch)W.and M.gauge woven stainless-steel wire cloth having a plain square weave.The parts of the apparatus are assembled and rigidly held by means of three bolts passing through the two plastic plates.Asuitable means is provided to suspend the basket-rack assembly from the raising and lowering device using a point on its axis.

Disks— Each tube is provided with a perforated cylindrical disk 15.3-±0.15-mm thick and 31.4±0.13mm in diameter.The disk is made of a suitable,transparent plastic material having a specific gravity of between 1.18and 1.20.Seven 3.2-mm holes extend between the ends of the cylinder,one of the holes being through the cylinder axis and the others parallel with it equally spaced on a 6-mm radius from it.All surfaces of the disk are smooth.

VITAMIN-MINERAL DOSAGE FORMS

Uncoated Tablets and Film-Coated Tablets— Place 1tablet in each of the tubes of the basket,add a disk to each tube,and operate the apparatus,using water maintained at 37±2as the immersion fluid.At the end of 30minutes,lift the basket from the fluid,and observe the tablets:all of the tablets disintegrate completely.If 1or 2tablets fail to disintegrate completely,repeat the test on 12additional tablets:not fewer than 16of the total of 18tablets tested disintegrate completely.

Plain Coated Tablets (Other Than Film-Coated Tablets)— Place 1tablet in each of the tubes of the basket and,if the tablet has a soluble external coating,immerse the basket in water at room temperature for 5minutes.Then add a disk to each tube,and operate the apparatus,using water maintained at 37±2as the immersion fluid.After 45minutes of operation in water,lift the basket from the fluid,and observe the tablets:all of the tablets have disintegrated completely.If 1or 2tablets fail to disintegrate completely,repeat the test on 12additional tablets:not fewer than 16of the total of 18tablets tested disintegrate completely.

Hard Gelatin Capsules— Apply the test for Uncoated Tablets,using 0.05Macetate buffer,prepared by mixing 2.99g of sodium acetate trihydrate and 1.66mLof glacial acetic acid with water to obtain 1000mLof solution having a pHof 4.50±0.05,maintained at 37±2as the immersion fluid.At the end of 45minutes,lift the basket from the fluid,and observe the capsules:all of the capsules disintegrate except for fragments from the capsule shell.If 1or 2capsules fail to disintegrate completely,repeat the test on 12additional capsules:not fewer than 16of the total of 18capsules tested disintegrate completely.

Soft Gelatin Capsules— Proceed as directed under Hard Gelatin Capsules.

BOTANICAL DOSAGE FORMS

Uncoated Tablets and Film-Coated Tablets— [NOTE—Omit the use of disks unless otherwise specified in the individual monograph.]Place 1tablet in each of the tubes of the basket,and operate the apparatus,using water maintained at 37±2as the immersion fluid.At the end of 20minutes,lift the basket from the fluid,and observe the tablets:all of the tablets disintegrate completely.If 1or 2tablets fail to disintegrate completely,repeat the test on 12additional tablets:not fewer than 16of the total of 18tablets tested disintegrate completely.

Plain Coated Tablets (other than Film-Coated Tablets)— [NOTE—Omit the use of disks,unless otherwise specified in the individual monograph.]Place 1tablet in each of the tubes of the basket and,if the tablet has a soluble external coating,immerse the basket in water at room temperature for 5minutes.Operate the apparatus using water maintained at 37±2as the immersion fluid.After 20minutes of operation in water,lift the basket from the fluid,and observe the tablets:all of the tablets have disintegrated completely.If 1or 2of the tablets fail to disintegrate completely,repeat the test on 12additional tablets:not fewer than 16of the total of 18tablets tested disintegrate completely.

Delayed-Release (Enteric-Coated)Tablets— Place 1tablet in each of the six tubes of the basket,and if the tablet has a soluble external coating,immerse the basket in water at room temperature for 5minutes.Then operate the apparatus using simulated gastric fluid TSmaintained at 37±2as the immersion fluid.After 1hour of operation in simulated gastric fluid TS,lift the basket from the fluid,and observe the tablets:the tablets show no evidence of disintegration,cracking,or softening.Operate the apparatus,using simulated intestinal fluid TS,maintained at 37±2as the immersion fluid,for the time specified in the monograph.Lift the basket from the fluid,and observe the tablets:all of the tablets disintegrate completely.If 1or 2tablets fail to disintegrate completely,repeat the test on 12additional tablets:not fewer than 16of the total of 18tablets tested disintegrate completely.

Hard Gelatin Capsules— Apply the test for Uncoated Tablets,using 0.05Macetate buffer,prepared by mixing 2.99g of sodium acetate trihydrate and 1.66mLof glacial acetic acid with water to obtain 1000mLof solution having a pHof 4.50±0.05,maintained at 37±2as the immersion fluid.At the end of 20minutes,lift the basket from the fluid,and observe the capsules:all of the capsules disintegrate except for fragments from the capsule shell.If 1or 2capsules fail to disintegrate completely,repeat the test on 12additional capsules:not fewer than 16of the total of 18capsules tested disintegrate completely.

Soft Gelatin Capsules— Proceed as directed under Hard Gelatin Capsules.

This test is provided to determine compliance with the dissolution requirements where stated in the individual class monographs for a tablet or capsule dosage form,except where the label states that the tablets are to be chewed.It does not apply to tablets or capsules designed to release vitamin or mineral content over a delayed or extended period of time.Soft gelatin capsule preparations of dietary supplements meet the requirements for Disintegration.

All dietary supplements belonging to USPClasses IIto VI,prepared as tablets or capsules,are subject to the dissolution test and criteria described in this chapter for folic acid (if present)and for index vitamins and index minerals.This test is also required if the product labeling includes a health claim concerning the relationship between folate deficiency and the risk of neural tube defects.The accompanying table lists the dissolution requirements for the individual USPclasses of dietary supplements.Class Idietary supplements are combinations of oil-soluble vitamins,which are exempt from dissolution requirements;hence,dissolution requirements do not apply to the oil-soluble vitamins contained in formulations belonging to Class IVor Class V.

Dietary Supplements—Vitamin–Mineral
Dosage Forms

Unless otherwise stated in the individual monograph,test 6dosage units for dissolution as directed under Dissolution á711ñ.

DISSOLUTION CONDITIONS FOR FOLIC ACID

NOTE—Perform this test under subdued light.

Medium: water;900mL.If the units tested do not meet the requirements for dissolution in water,test 6additional dosage units for dissolution in a medium of 900mLof 0.05MpH6.0citrate buffer solution,prepared by mixing 9.5mLof 0.1Mcitric acid monohydrate and 40.5mLof 0.1Msodium citrate dihydrate in a 100-mLvolumetric flask,diluting with water to volume,mixing,and adjusting to a pHof 6.0by using either 0.1Mhydrochloric acid or 0.1Msodium hydroxide solution.

Apparatus 1: 100rpm,for capsules.

Apparatus 2: 75rpm,for tablets.

Time: 1hour.

DISSOLUTION CONDITIONS FOR INDEX VITAMINS AND INDEX MINERALS

Medium: 0.1Nhydrochloric acid;900mL.

Apparatus 1: 100rpm,for capsules.

Apparatus 2: 75rpm,for tablets.

Time: 1hour.

Medium: 0.1Nhydrochloric acid;1800mL.

Apparatus 1: 100rpm,for capsules.

Apparatus 2: 75rpm,for tablets.

Time: 1hour.

SELECTION OF INDEX VITAMINS AND INDEX ELEMENTS

PROCEDURES

Folic Acid— Determine the amount of C19H19N7O6dissolved by employing the procedure set forth in the Assay for folic acidunder Oil-and Water-Soluble Vitamins with Minerals Tablets,in comparison with a Standard solution having a known concentration of USP Folic Acid RSin the same medium.

Niacin or Niacinamide,Pyridoxine,Riboflavin,and Thiamine— Determine the amount of the designated index vitamin dissolved by employing the procedure set forth in the Assay for niacin or niacinamide,pyridoxine,riboflavin,and thiamineunder Water-Soluble Vitamins Tablets.

Ascorbic Acid— Determine the amount of C6H8O6dissolved by adding 10mLof 1.0Nsulfuric acid and 3mLof starch TSto 100.0mLof test solution,and titrating immediately with 0.01Niodine VS.Perform a blank determination,and make any necessary correction.

Iron,Calcium,Magnesium,and Zinc— Determine the amount of the designated index element dissolved by employing the procedure set forth in the appropriate Assayunder Minerals Capsules.

TOLERANCES

This test is provided to determine compliance with the dissolution requirements where stated in the individual monograph for a tablet or capsule dosage form.See Dissolution á711ñfor description of apparatus used,Apparatus Suitability Test,and other related information.Of the types of apparatus described in á711ñ,use the one specified in the individual monograph.Where the label states that an article is enteric-coated,and a dissolution or disintegration test that does not specifically state that it is to be applied to enteric-coated articles is included in the individual monograph,the test for Delayed-Release Articlesunder Drug Release á724ñis applied,unless otherwise specified in the individual monograph.Compliance with dissolution requirements is determined by testing 6dosage units individually,or testing 2or more counted number of dosage units in each vessel,and measuring the dissolution of one or more index/marker compound(s)or the extract specified in the individual monograph.This nonspecific dissolution is intended to be diagnostic of known technological problems that may arise due to coatings,lubricants,disintegrants,and other substances inherent in the manufacturing process.Further,this dissolution measurement allows an assessment of the extent of decomposition of the extract to polymeric or other nondissoluble compounds that may have been produced by excessive drying or other manipulations involved in the manufacture of botanical extracts.The operative assumption inherent in this procedure is that if the index or marker compound(s)or the extract is demonstrated to have dissolved within the time frame and under conditions specified,the dosage form does not suffer from any of the above formulation or manufacturing related problems.

PROCEDURES

INTERPRETATION

Pooled Sample— Unless otherwise specified in the individual monograph,the requirements are met if the quantities of the index or marker compound(s)or the extract dissolved from the pooled sample conform to the accompanying acceptance table.The quantity,Q,is the amount of dissolved index or marker compound(s)or the extract specified in the individual monograph,expressed as a percentage of the labeled content.The 5%,15%,and 25%values in the acceptance table are percentages of the labeled content so that these values and Qare in the same terms.