DISINTEGRATION TESTS P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Table of Contents Section I
Section Name ntroduction of Introduction
Disintegrati Disintegration on test
2.
Application and Uses
3
Advantages and disadvantage
4
General Principles involved in testing
5
Different Methods
6
Disintegration Tests
Instrumentation
(Models)
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Disintegration Disinteg ration Test Test It is a measure of the time required under a given set of conditions for a group of tablets to disintegrate into particles which will pass through a 10 mesh screen. The test is useful as a quality assurance tool for conventional dosage forms.
Introduction of Disintegration Tests
For a drug to be absorbed from a solid dosage form after oral administration, it must first be in solution, and the first important step toward this condition is usually the breakup of the tablet; a process known as disintegration. disintegration . P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Disintegration Test It is a method to determine the resistance or disintegration of solid preparations for internal use in the test fluids. Dosage forms: Tablets, tablet coated with suitable coating agents, pills, capsules, granules or enteric coated preparations.
Introduction of Disintegration Tests
This method is not applied for preparations exceeding 20.00 mm in diameter, for sustained release preparations, or for preparations which subject to the Dissolution Test. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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1.To find out the time it takes for a solid oral dosage form to completely disintegrate. The time of disintegration is a measure of the quality
Application and Uses:
Ex:
Disintegration time ± too high Tablet ± too highly compressed Capsule shell gelatin ± not of pharmacopoeial quality
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2.Disintegration
test is a simple test which helps in the preformulation stage to the formulator.
Application and Uses:
It helps in the of manufacturing variables, such as compressional force and dwell time.
3.
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4.This
test is also a simple in-process control tool to ensure uniformity from batch to batch and among different tablets.
Application and Uses:
5.It is also an important test in the quality control of tablets and hard gelatin capsules.
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Advantages:
Advantages and disadvantages:
This test is simple in concept and in practice. It is very useful in preformulation, optimisation and in quality control.
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Disadvantages:
Advantages and disadvantages:
Disintegration test cannot be relied upon for the assurance of bioavailability.
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Pr inciples
Involved in Disinteg ra tion Appar atus
Principles Involve
Discs are used in the disintegration test to avoid the Floating of tablet when immersed in the medium ,so that equal disintegration occurs in all the tablets under testing.
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Principles Involve
The usual medium used is water (neutral) for most of the dosage forms; In some cases we are using acidic and basic medium case
Ex: Enteric coated ones the usual procedure is first we are dipping in HCl to mimic the gastric fluid medium and then we are using an alkaline medium to dissolve the enteric coated phalate layers mimicking the intestinal environment. | P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Principles Involve In general the specification of temperature is not so important in case of solid dosage forms where as in case of semi-solid dosage forms being made of lipids temperature should be specified in-order to avoid melting of lipids.
The use of discs is to avoid floating of dosage units ensuring uniform exposure of medium to all the surfaces of the dosage unit.
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Disinteg ra tion Test Methods The disintegration test for each dosage form is given in the pharmacopoeia. There are some general tests for typical types of dosage forms. However, the disintegration test prescribed in the individual monograph of a product is to be followed.
Methods or Procedures
If the monograph does not specify any specific test, the general test for the specific dosage form may be employed.
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Disinteg ra tion Test Methods
Methods or Procedures
General Procedure:
1. Attach the basket-rack assembly to the bearing, immerse in fluid in a beaker, and adjust the apparatus so as to raise and lower the basket smoothly at a constant frequency of 29 to 32 cycles per minute through a distance of 53 to 57 mm. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Disinteg ra tion Test Methods
Methods or Procedures
General Procedure:
2. At the lowest point of the downward stroke, the wire mesh must be 25 mm distant from the bottom of the beaker and the volume of the fluid in the beaker is such that, at the lowest point of the downward stroke, the top of the basket is on a level with the surface of the fluid. Maintain the temperature of the fluid at 37 ± 2oC during the test.
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Disinteg ra tion Test Methods
Methods or Procedures
General Procedure:
3. Place the Sample, except for granules, to be tested in each of the 6 tubes of the basket, immerse the basket in a suitable volume of test fluid, maintained in a beaker at the desired temperature, and operate the apparatus for the directed period of time. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Disinteg ra tion Test Methods
Methods or Procedures
General Procedure: 4.
At the end of that period, lift the basket gently from the fluid to permit the observation of the samples in the glass tubes. When it is directed to put auxiliary disks in the tubes, place a sample in each tube, then put the disk gently in each tube with the upper side up, and proceed as directed above. If the determination is difficult, the auxiliary disk may be omitted. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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H ar d Gelatin Capsules
Methods or Procedures
Apply the test for Uncoated Tablets. Attach a removable wire cloth, which has a plain square weave with 1.8- to 2.2-mm mesh apertures and with a wire diameter of 0.60 to 0.655 mm, as described under BasketRack Assembly, to the surface of the upper plate of the basket-rack assembly. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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H ar d Gelatin Capsules
Methods or Procedures
Observe the capsules within the time limit speci¿ed in the individual monograph: all of the capsules have disintegrated except for fragments from the capsule shell.
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S oft Gelatin Capsules
Methods or Procedures
Proceed as directed under Hard Gelatin Capsules.
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U ncoated Tablets
Methods or Procedures
Place 1 tablet in each of the six tubes of the basket and operate the apparatus, using distilled water as meduim and maintained at 37oC the immersion Àuid unless otherwise speci¿ed in the individual monograph. 15 minutes
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U ncoated Tablets
Methods or Procedures
At the end of the time limit speci¿ed in the monograph, lift the basket from the Àuid, and observe the tablets: all of the tablets have disintegrated completely.
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P lain lain Coated Co ated Tablets Tablets
Methods or Procedures
Apply the test for Uncoated Tablets, but the time of operation is 30 minutes.
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Delayed-Rele Delayed-Release ase (Ente r ic ic
Coated) Tablets
Methods or Procedures
Place 1 tablet in each of the six tubes of the basket and, Suspend the assembly in a beaker with 0.1 M Hcl. Operate without discs for 2 hrs. (Unless otherwise stated in the monograph). Remove the set up from the liquid.
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Delayed-Relea Delayed-Release se (Ente r ic ic
Coated) Coate d) Tablet Tabletss
Methods or Procedures
Replace the liquid in beaker with mixed phosphate buffer of pH 6.8 and, Add a disc to each tube and operate the apparatus for further 1 hr. Remove the apparatus from the liquid. If no residue remains on the screen, then the six tablets are said to be completely disintegrated. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Delayed-Release (Ente r ic
Coated) Tablets
Methods or Procedures
Operate the apparatus, using simulated intestinal Àuid TS maintained at 37 C as the immersion Àuid, for the time speci¿ed in the monograph. Lift the basket from the Àuid, and observe the tablets: all of the tablets disintegrate completely.
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Buccal Tablets
Methods or Procedures
Apply the test for Uncoated Tablets. After 4 hours, lift the basket from the Àuid, and observe the tablets: all of the tablets have disintegrated.
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S ublingual Tablets
Methods or Procedures
Apply the test for Uncoated Tablets. Observe the tablets within the time limit speci¿ed in the individual monograph: all of the tablets have disintegrated.
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P essar ies and S uppositor ies
Methods or Procedures
Place a pessary or a suppository on the lower perforated disc of the metal device. Insert the device into the cylinder and attach this to the sleeves. The same operation is repeated with further two pessaries or suppositories and metal devices and sleeves. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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P essar ies and S uppositor ies
If specified, place each piece of apparatus in a vessel containing 4 liters of water at a temperature of 36-37 ºc, fitted with a slow stirrer and a means of holding the top of apparatus 90 mm below the surface of water. Alternatively, all the three pieces of apparatus may be placed together in a vessel containing 12 liters of water.
Methods or Procedures
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P essar ies and S uppositor ies
After each 10 min invert each apparatus without removing from the liquid.
Methods or Procedures
Disintegration is said to be completed when the moulded pessary or suppository: is completely dissolved has dispersed into its component parts or remains on the surface (in the case of melted fatty substances) P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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P essar ies and S uppositor ies
sinks to the bottom(in the case of insoluble powders)
Methods or Procedures
dissolves (in the case of soluble components) Or may be distributed in one or more of these ways: - has become soft with appreciable change in shape - consisting of only a soft mass having no solid core which cannot be pressed with a glass rod. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Formulation
United States Pharmacopoeia 2009
Hard Gelatin Capsules
Same as uncoated tablets. Use a circular cloth mesh of diameter 0.600.655mm & 1.8-2.2mm square mesh size. No palpable material to remain on the mesh.
Soft gelatin capsules
Same as uncoated tablets. Use a circular cloth mesh of diameter 0.600.655mm & 1.8-2.2mm square mesh size. No palpable material to remain on the mesh.
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Formulation
United States Pharmacopoeia 2009
Uncoated tablets
Uses disintegration apparatus with specified liquid medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.
Chewable tablets
Same as uncoated tablets. Uses disintegration apparatus with specified liquid medium & for 4 hours or as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.
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Formulation
Non-film coated tablets
Film coated tablets
United States Pharmacopoeia 2009
Same as uncoated tablets. Uses disintegration apparatus with specified liquid medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative. Same as uncoated tablets. Uses disintegration apparatus with specified liquid medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.
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Formulation
Gastro resistant tablets (Enteric Coated)
United States Pharmacopoeia 2009
Uses disintegration apparatus with stimulated gastric fluid TS at 37+-2 OC for 1 hour, if there is no cracking or breaking of coat, continue with stimulated intestinal fluid at same temperature for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.
USP Specifications | P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Formulation
United States Pharmacopoeia 2009
Buccal Tablets
If
Sublingual Tablets
If
1 or 2 tablets fail to disintegratecompletely, repeat the test on 12 additional tablets: not less than 16 ofthe total of 18 tablets tested disintegrate completely. 1 or 2 tablets fail to disintegrate completely, repeat the test on 12 additional tablets: not less than 16 of the total of 18 tablets tested disintegrate completely.
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Formulation
Suppositorie s
United States Pharmacopoeia 2009
Uses disintegration apparatus with water R or specified liquid medium & for 30 min. for suppositories with fatty base and for 60 min. for suppositories with water soluble base. If 12 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.
Effervescent A total of 6 units tested Uses 200ml of water tablets R at 15-25OC. Disintegrates within 5 min. or as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.
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Formulation
United States Pharmacopoeia 2009
Modified release Disintegration test not applicable capsules Modified release Disintegration test not applicable tablets
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Appar atus for Tablets and Capsules:
Instrumentations:
It consists of: Basket-rack assembly Beaker (1 L capacity) Thermostat arrangement Mechanical device (raising and lowering the basket) Immersion fluid.
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Basket- r ack
assembly
Instrumentations:
Basket made of transparent polyvinyl or other plastic material It consists of six cylindrical glass tubes (length: 77.5+/- 2.5 cm long, internal diameter: 20.7 - 23 mm, wall thickness: 1.0-2.8 mm).
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Basket- r ack
assembly
Instrumentations:
The tubes are held in position by two superimposed transparent plastic plates, perforated by six holes having the same diameters as the tubes. (Diameter: 8.8-9.2mm thickness: 5-7mm)
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Basket- r ack
assembly
Instrumentations:
To the underside of the lower plastic plate is a woven stainless steel wire cloth with a plain square weave with 1.82.2mm mesh apparatus and with a diameter of 0.600.665mm.
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Basket- r ack
assembly
Instrumentations:
The upper plate is covered with a six holed stainless steel disc, each about 24+/- 2 mm in diameter, which fits over the tubes and holds them between the plastic plates.
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Basket- r ack
assembly
Instrumentations:
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Disc
Instrumentations:
A cylindrical disc made of transparent plastic is provided for each tube, (Diameter: 20.7+/0.15 mm; thickness: 9.5+/- 0.15; relative density: 1.18- 1.20).
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Disc
Instrumentations:
In each disc there are five holes (diameter of 2mm) one in the center and four surrounded equidistantly on a circle of radius 6 mm from the centre are provided.
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Disc
Instrumentations:
Four equally trapezoidal shaped grooves are cut in the lateral surface of the disc they are 9.5 mm wide and 2.25mm deep at the lower surface 1.6mm square.
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Disc
Instrumentations:
disks with metal contact ring and metal needles
Disks with ring (no needle)
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Disc
Instrumentations: disks and metal contact plate
Standard Disintegra tion USP/EP Disks P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Medium
Instrumentations:
The assembly is to be suspended in a 1L beaker. The volume of the liquid is such that the wire mesh at its highest point is atleast 25mm below the surface of the liquid, and its lowest point is atleast 25 mm above the bottom of the beaker; one must make sure that the top of the basket rack assembly shouldn¶t be submerged.
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H eating
Device
Instrumentations:
There is a thermostat arrangement for heating the liquid and maintaining the temperature at 35 and 39oC
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Instrumentations: Mechanical Device Basket-rack assembly Heating Device Individual glasstube Disc Sieve meshes P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Diagram of Assembly Apparatus Basket-rack Basket-rack Assembly Assembly
Instrumentations:
Cylinder in down position Level f Liquid at 37oC 2.5L of Medium
Support
Device for Raising and lowering Basket-Rack Assembly P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Diagram of Glass Tube, Plastic Disk, and Plunger
Wire Rod (3.2 cm x 9 cm) 12 Holes
6 Holes
2 mm Wall Inside
diameter of NLT 21.0mm and NMT 22.5mm Disk Screen
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Appar atus for P essar ies and S uppositor ies
Instrumentations:
A transparent sleeve made of glass or plastic. (Height: 60mm, Internal Diameter: 52 mm; appropriate wall thickness). A metal device consisting of two stainless discs; each of which contains 39 holes, each 4 mm in diameter. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Appar atus for P essar ies and S uppositor ies
Instrumentations:
The discs are separated by a distance of 30 mm. The metal device is attached to the outer sleeve by means of three equally shaped hooks; also the diameter of disc is closely similar to the internal diameter of the sleeve. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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S uppositor ies
Disinteg r ation Tester
Instrumentations:
3 independent test stations perform tests simultaneously All test cylinders turn 180 o C ( 10 mins) Test cylinders turning interval can be programmed from 1 min to 99 min Removable thermostat can be programmed to maintain temperature between 30 o C to 50 o C (+/- 0.5 o C) in the bath P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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y Disinteg r ation Test S uppositor P T S -3E
Instrumentations:
According to the Pharmacopoeia monograph 3 samples are tested at the same time. The total testing period can be pre-set within a range of 1 minute to 10 hours. When used to test suppositories the sample baskets will turn automatically each 10 minutes through 180 degrees as specified in the relevant monograph. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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y Disinteg r ation Test S uppositor P T S -3E
Automatic rotation through 180 degrees when suppositories are tested Selectable cycling time for 1 - 10 Min. Programmable testing time for 1 min. to 10 hours Digital display of elapsed testing time Recall pre-set total time
Instrumentations:
Basket sample Holder Complete
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y Disinteg r ation Test S uppositor P T S -3E
Built-in circulation thermostat, adjustable for 30°C - 40°C +/- 0.5°C accuracy Simultaneous test of 3 samples possible as per EP monograph Heating system protected against grease intrusion Water bath volume > 12 L
Instrumentations:
Basket Including Suppository P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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S ingle Basket
Instrumentations:
Disinteg ra tion Appar atus The cylinder moves up and down 30 to 32 cycles/min. In one liter beaker filled with distilled water, maintained at 37 c + 2 c by thermostatically controlled hot plate complete with beaker of `borosil` to work on 220/230 volts, with wire and plug, ready to switch on P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001
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Double Basket Disinteg ra tion Appar atus
Instrumentations:
Double basket unit , equipped with water bath designed to conduct disintegration tests as per new IP & USP standards. Temperature of the water bath is precisely controlled by sensitive thermostat.
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T ri ple Basket Disinteg ra tion Appar atus
Instrumentations:
It is suitable for tablet and capsule disintegration testing as per USP<701/2040> and EP<2.9.1/2.9.1.2> Operates 3 Baskets which are connected to a central stroke arm
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Automatic Tablet Disinteg ra tion Testing Automatic measuring of tablet thickness Graphical display of disintegration characteristics over time (curve) Precise inductive measuring technology Corrosion-free Self-centering magnetic baskets Fast and easy cleaning 100% USP and EP compliant design
Instrumentations:
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Instrumentations:
Automatic tablet disinteg ra tion tester with single testing station
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Instrumentations:
Automatic tablet disinteg ra tion tester with two independent testing stations
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Instrumentations:
Automatic tablet disinteg ra tion tester with thr ee independent testing stations
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Instrumentations:
Automatic tablet disinteg ra tion tester with four independent testing stations
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Manual Disinteg ra tion Testing Pharmacopoeia compliance and qualification Simple operation Quick-release basket design One-piece water bath Independent heater / circulator Low liquid-level sensor
Instrumentations: Acoustic signal at end of test Constant monitoring of time and temperature (displayed on LCD screen)
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Instrumentations:
Manual Disinteg r ation Testing
ONE TEST STAT ION
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Instrumentations:
Manual Disinteg r ation Testing
TWO TEST STATION
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Instrumentations:
Manual Disinteg r ation Testing
THREE TEST STATION
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Instrumentations:
Manual Disinteg r ation Testing
THREE TEST STATION
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