2024/1/12 上午11:23 USP-NF 〈701〉 Disintegration

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BRIEFING

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〈701〉 Disintegration . This proposal is based on the version of the chapter official as of May 1, 2020. The European Pharmacopoeia is the
coordinating pharmacopeia for the international harmonization of the compendial standards for the Disintegration general chapter, as part of the

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process of international harmonization of monographs and general analytical methods of the European, Japanese, and United States
pharmacopeias. The following general chapter, which represents the OFFICIAL INQUIRY STAGE 2A of Revision 5 (version 1) to the Pharmacopeial
Discussion Group (PDG) harmonized document, includes changes in the following sections:

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1. Introduction.
2. Apparatus: clarified Test A Basket-Rack Assembly and inclusion of the Test B Basket-Rack Assembly.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
(GCDF: M. Marques)
Correspondence Number—C324216
Current DocID: GUID-6B930D76-6026-4693-844B-FB9C90728D4F_3_en-US

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〈701〉 DISINTEGRATION
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This general chapter is harmonized with the corresponding texts of the European Pharmacopoeia and/or the Japanese Pharmacopoeia. The
texts of these pharmacopeias are therefore interchangeable, and the methods of the European Pharmacopoeia and/or the Japanese
Pharmacopoeia may be used for demonstration of compliance instead of the present general chapter. These pharmacopeias have undertaken
not to make any unilateral change to this harmonized chapter.
Portions of the present general chapter text that are national USP text, and therefore not part of the harmonized text, are marked with
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symbols (◆◆) to specify this fact.

This test is provided to determine whether tablets, capsules, ◆or granules◆ disintegrate within the prescribed time when placed in a liquid
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medium at the experimental conditions presented below. ◆Compliance with the limits on Disintegration stated in the individual monographs is
required. Determine the type of units under test from the labeling and from observation, and apply the appropriate procedure to 6 or more
dosage units.◆
For the purposes of this test, disintegration does not imply complete solution of the unit or even of its active constituent. Complete
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disintegration is defined as that state in which any residue of the unit, except fragments of insoluble coating or capsule shell, remaining on the
screen of the test apparatus or adhering to the lower surface of the disk, if used, is a soft mass having no palpably firm core.
Use the Test A basket-rack assembly for tablets and capsules that are not greater than 18 mm at the longest dimension, ◆and for granules◆.
For tablets and capsules larger than 18 mm at the longest dimension, use the Test B basket-rack assembly. ◆If the monograph does not state
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which basket-rack assembly to be used, use Test A basket-rack assembly.◆

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APPARATUS
The apparatus consists of a basket-rack assembly, a 1000-mL low-form beaker 138–160 mm in height and havingwith an inside diameter of
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97–115 mm for the immersion fluid, a thermostatic arrangement for heating the fluid at 35°–39°, and a device for raising and lowering the
basket in the immersion fluid at a constant frequency rate of 29–32 cycles/min through a distance of NLT 53 mm and NMT 57 mm.53–57 mm.
The volume of the fluid in the vesselbeaker is such that at the highest point of the upward stroke, the wire mesh remains at least 15 mm below
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the surface of the fluid and descends to not less than 25 mm from the bottom of the vessel beaker on the downward stroke. At no time should
the top of the basket-rack assembly become submerged. The time required for the upward stroke is equal to the time required for the downward
stroke, and the change in stroke direction is a smooth transition, rather than an abrupt reversal of motion. The basket-rack assembly moves
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vertically along its axis. There is no appreciable horizontal motion or movement of the axis from the vertical.

Test A Basket-Rack Assembly

The basket-rack assembly consists of 6 open-ended transparent tubes, each 75.0–80.0 mm long and havingwith an inside diameter of 20.7–
23 mm20.7–23.0 mm and a wall thickness of 1.0–2.8 mm thick; the tubes are held in a vertical position by two plates, each 88–92 mm in
diameter and 55.0–8.5 mm in thickness, with 6 holes, each 22–26 mm in diameter, equidistant from the center of the plate and equally spaced

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from one another. Attached to the under surface of the lower plate is a woven stainless steel wire cloth, which has a plain square weave with
1.8–2.2-mm apertures and with a wire diameter of 0.57–0.66 mm. The parts of the apparatusbasket-rack are assembled and rigidly held by
means of 3 bolts passing through the 2 plates. A suitable means is provided to suspend the basket-rack assembly from the raising and lowering
device using a point on its axis.
The design of the basket-rack assembly may be varied somewhat, provided the specifications for the glass tubes and the screen mesh size
are maintained. The basket-rack assembly conforms to the dimensions found in Figure 1.

Disks for Test A Basket-Rack Assembly

The use of disks is permitted only where specified or allowed ◆in the monograph. If specified in the individual monograph,◆ Each tube of the
Test A basket-rack assembly is provided with a cylindrical disk 9.35–9.65 mm thick and 20.55–20.85 mm in diameter. The disk is made of a

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suitable transparent plastic material having a specific gravity of 1.18–1.20. Five parallel 1.9–2.1-mm holes extend between the ends of the
cylinder. One of the holes is centered on the cylindrical axis. The other holes are parallel to the cylindrical axis and centered 5.8–6.2 mm from
the axis on imaginary lines perpendicular to the axis and to each other, as defined in Figure 1. Four identical trapezoidal-shaped planes are cut

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into the wall of the cylinder, nearly perpendicular to the ends of the cylinder. The trapezoidal shape is symmetrical; its parallel sides coincide
with the ends of the cylinder and are parallel to an imaginary line connecting the centers of two adjacent holes 6 mm from the cylindrical axis.
The parallel side of the trapezoid on the bottom of the cylinder has a length of 1.5–1.7 mm, and its bottom edges lie at a depth of 1.5–1.8 mm

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from the cylinder’s circumference. The parallel side of the trapezoid on the top of the cylinder has a length of 9.2–9.6 mm, and its center lies at
a depth of 2.5–2.7 mm from the cylinder’s circumference. All surfaces of the disk are smooth. If the use of disks is specified ◆in the individual
monograph,◆ add a disk to each tube, and operate the apparatus as directed under Procedure. The disks conform to dimensions found in Figure
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Figure 1. Disintegration apparatus. Test A basket-rack assembly. (All dimensions are expressed in millimeters.)

Test B Basket-Rack Assembly

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The Test B basket-rack assembly consists of 3 open-ended transparent tubes, each 75.0–80.0 mm long with an inside diameter of ◆32.0–
34.6◆ mm and a wall thickness of 2.0–3.0 mm. The tubes are held in a vertical position by 2 plastic plates, each 95–99 mm in diameter and
7.5–10.5 mm in thickness, with 3 holes. The holes are equidistant from the center of the plate and equally spaced from one another. Attached
to the under surface of the lower plate is a woven stainless steel wire cloth, which has a plain square weave with mesh apertures of 1.8–2.2 mm
and with a wire diameter of 0.60–0.66 mm. The plates are held firmly in position by vertical metal rods at the periphery. A metal rod is also fixed
to the center of the upper plate to enable the assembly to be attached to a mechanical device. The difference between the diameter of the
plastic plates, which hold the tubes in a vertical position and the inside diameter of the beaker should be not more than 6 mm.
The design of the Test B basket-rack assembly may be varied somewhat provided the specifications for the glass tubes and the screen mesh
size are maintained. The Test B basket-rack assembly conforms to the dimensions shown in Figure 2.

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Figure 2. Disintegration apparatus. Test B basket-rack assembly. (All dimensions are expressed in millimeters.)

Disks for Test B Basket-Rack Assembly

The use of disks is permitted only where specified or allowed. Each tube of the Test B basket-rack assembly is provided with a cylindrical disk
15.15–15.45 mm thick and 31.27–31.53 mm in diameter. The disk is made of suitable transparent plastic material having a specific gravity of
1.18–1.20. Each disk is pierced by 7 parallel holes, each 3.05–3.25 mm in diameter. One of the holes is centered on the cylindrical axis. The

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other holes are parallel to the cylindrical axis and spaced equally on a circle with a diameter of 8.3–8.5 mm centered on the axis. All surfaces of
the disk are smooth.

PROCEDURE ◆ AND CRITERIA

Procedure and Criteria for Uncoated or Plain-Coated Tablets

procedure for uncoated or plain-coated tablets

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Place 1 dosage unit in each of the 6 tubes of the basket◆-rack assembly◆ and, if prescribed, add a disk. Operate the apparatus, using ◆water
or◆ the specified medium as the immersion fluid, maintained at 37 ± 2°. At the end of the time limit specified ◆in the monograph,◆ lift the

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basket◆-rack assembly◆ from the fluid, and observe the tablets. All of the tablets ◆should◆ have disintegrated completely. If 1 or 2 tablets fail
to disintegrate completely, repeat the test on 12 additional tablets.

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◆
criteria for uncoated or plain-coated tablets
1. If 6 tablets are tested, all 6 of the tablets are disintegrated.
2. If 18 tablets are tested,◆ the requirement is met if not fewer than 16 of the total of 18 tablets are disintegrated.

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◆
Procedure and Criteria for Delayed-Release Tablets and Capsules (tablets or capsules that are formulated with acid-resistant
or enteric coatings)

procedure for delayed-release tablets and capsules

Place 1 dosage unit in each of the 6 tubes of the basket. If the dosage units are not sugar-coated, proceed to the Acid stage. If testing

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tablets that have a soluble external sugar coating, immerse the basket in water at room temperature for 5 min and then immediately proceed
to the Acid stage. If specified in the monograph, add 1 disk to each tube.
Acid stage

Temperature: 37 ± 2°
Time: 1 h
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Immersion fluid: 0.1 M hydrochloric acid, or simulated gastric fluid TS, or as specified in the monograph

If after 1 h no dosage unit shows evidence of disintegration , cracking, or softening, proceed with the Buffer stage.
Buffer stage
Immersion fluid: pH 6.8 phosphate buffer, or simulated intestinal fluid TS, or as specified in the monograph
Temperature: 37 ± 2°
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Time: As specified in the individual monograph

criteria for delayed-release tablets and capsules

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Acid stage: No dosage unit shows evidence of disintegration , cracking, or softening.

Buffer stage: Apply the Criteria for Uncoated or Plain-Coated Tablets.

Procedure and Criteria for Buccal Tablets, Sublingual Tablets, Capsules, Tablets for Oral Suspension, Tablets for Oral Solution,
Tablets for Topical Solution, Orally Disintegrating Tablets, and Chewable Tablets
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Apply the Procedure and Criteria for Uncoated or Plain-Coated Tablets.

Procedure and Criteria for Effervescent Tablets for Oral Solution

procedure for effervescent tablets for oral solution

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Place 1 tablet in each of 6 beakers containing 200 mL of water. A suitable beaker will have a nominal volume of 250–400 mL.
Time: 5 min or as specified in the individual monograph

criteria for effervescent tablets for oral solution

Numerous bubbles of gas are evolved. After 5 min or as specified in the individual monograph, the evolution of gas around each tablet or its
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fragments has ceased. Each tablet has dissolved or disintegrated and has been dispersed in the water so that no appreciable agglomerates
remain.

Procedure and Criteria for Effervescent Granules

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procedure for effervescent granules

In each of 6 beakers containing 200 mL of water place 1 dose of the effervescent granules. A suitable beaker will have a nominal volume of
250–400 mL.
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Time: 5 min or as specified in the individual monograph

criteria for effervescent granules

Numerous bubbles of gas are evolved. After 5 min or as specified in the individual monograph, the evolution of gas around the granules in
each beaker has ceased. The granules have dissolved or disintegrated and have been dispersed in the water.◆

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The use of automatic detection employing modified disks is permitted where the use of disks is specified or allowed. Such disks must comply
with the requirements for density and dimension given in this chapter.

Auxiliary Information - Please check for your question in the FAQs before contacting USP.

Topic/Question Contact Expert Committee

<701> DISINTEGRATION Margareth R.C. Marques GCDF2020 General Chapters - Dosage Forms
Principal Scientific Liaison 2020

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DocID: GUID-6B930D76-6026-4693-844B-FB9C90728D4F_30201_en-US
DOI: https://doi.org/10.31003/USPNF_M99460_30201_01
DOI ref: mkgpt

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