Introduction
A dissolution tester is a pharmaceutical instrument used to measure the dissolution rate of solid oral dosage forms, such as tablets and capsules, which is the rate and extent at which the active pharmaceutical ingredient is released from the dosage form into a dissolution medium under standardized conditions, and it is one of the most important quality control tests for oral drug products. The tester consists of a thermostatically controlled water bath, typically maintained at 37 degrees Celsius to simulate human body temperature, containing a number of dissolution vessels, usually six or twelve, each filled with a specified volume of dissolution medium; a paddle or basket apparatus is lowered into each vessel and rotated at a controlled speed, such as 50 or 75 revolutions per minute, and a dosage unit is placed in each vessel, after which samples of the medium are withdrawn at specified time points and analyzed, typically by UV spectrophotometry, HPLC, or other methods, to determine the amount of drug released as a function of time, producing a dissolution profile. Dissolution testing simulates the conditions of the gastrointestinal tract and provides critical information on the release behavior of the drug, which affects its bioavailability and therapeutic efficacy, and the test is used for batch-to-batch consistency, formulation development and optimization, quality control of finished products, and regulatory submissions, following the methods and acceptance criteria of pharmacopeial standards such as the United States Pharmacopeia and the European Pharmacopoeia. Dissolution testers are used in pharmaceutical manufacturing plants, quality control laboratories, research and development centers, and regulatory laboratories, and modern systems include automated sampling, in-line analysis, and data management software. Features include precise temperature and speed control, multi-vessel operation, automatic sampling, and compliance with pharmacopeial methods. With their importance in ensuring drug quality and performance, dissolution testers are essential instruments in the pharmaceutical industry.
Dissolution Tester LDLT-T2014
Dissolution Tester has a speed range of 20 to 200 rpm with an accuracy of ±2 rpm. It ensures precise control over experiment parameters such as temperature, time, and rotation speed. Th...
Dissolution Tester LDLT-T2015
Dissolution Tester features 6 vessels and 6 poles at the front, with an optional two vessels at the back. It is highly accurate, with speed accuracy of ±2 rpm and temperature accuracy o...
Dissolution Tester LDLT-T2018
Dissolution Tester has 14 vessels, and 12 high-quality stainless-steel paddles arranged in a double-row configuration. It operates at a constant temperature of 37°C ± 0.5°C within a s...
Dissolution tester LDLT-T2016
Dissolution tester A16 is adopted with microprocessor controlled technology, automatically controls the temperature, time and rotation speed of experiment. The vessels and poles are fitt...
Dissolution tester LDLT-T2017
Dissolution Tester is adopted with adopted with microprocessor controlled technology, automatically controls the temperature, time and rotation speed of experiment. The vessels and poles...
Dissolution tester LDLT-T2012
Dissolution tester is adopted with microprocessor controlled technology, automatically controls the temperature, time and rotation speed of experiment. Its test parameters can be preset ...
Dissolution tester LDLT-T2013
Dissolution tester is adopted with microprocessor controlled technology, automatically controls the temperature, time and rotation speed of experiment. Its test parameters can be preset ...
Dissolution tester LDLT-T2010
Dissolution tester is adopted with microprocessor controlled technology, automatically controls the temperature, time and rotation speed of experiment. Its test parameters can be preset ...
Dissolution tester LDLT-T2011
Dissolution tester is adopted with microprocessor controlled technology, automatically controls the temperature, time and rotation speed of experiment. Its test parameters can be preset ...
Standards
USP General Chapter <711>-Dissolution (basket, paddle, reciprocating cylinder and flow-through cell apparatus)
Complies with the above standards, but is not limited to them.
Features
1. Dissolution tester for evaluating drug release from pharmaceutical dosage forms.
2. Standardized vessel assembly with paddle or basket apparatus per pharmacopoeial specifications.
3. Suitable for pharmaceutical quality control, research and regulatory compliance testing.
4. Precise temperature control, stirring speed and sampling for reproducible results.
5. Includes water bath, vessels, paddles/baskets, drive system, sampling and controller.
FAQ
Q1: What testing scenarios is this tester mainly applied to?
A: The dissolution tester is used in pharmaceutical quality control laboratories, drug manufacturing, research and development, and regulatory testing to evaluate the drug release rate and extent from oral solid dosage forms including tablets, capsules, granules and powders under standardized physiological conditions. It supports routine quality control testing of finished pharmaceutical products, formulation development and optimization, generic drug bioequivalence studies, regulatory compliance testing per pharmacopoeial requirements, and batch release testing. The standardized apparatus and procedure provide in vitro data that correlates with in vivo drug release behavior. It is essential for pharmaceutical manufacturers, contract research organizations and regulatory testing laboratories requiring reliable dissolution testing for product quality control, formulation development, bioequivalence assessment, regulatory compliance and batch release, where dissolution profile is a critical quality attribute indicating drug release behavior, formulation performance, batch consistency and potential bioavailability per USP, EP, ChP and other pharmacopoeial requirements for oral dosage forms.
Q2: What standards does the tester comply with?
A: The dissolution tester follows USP 711, EP 2.9.3, ChP and other pharmacopoeial monographs for dissolution testing. Apparatus 1 (basket) and Apparatus 2 (paddle) specifications including vessel dimensions, paddle/basket geometry, stirring speed and temperature follow pharmacopoeial requirements. The instrument complies with IEC 61010 laboratory safety standards. Mechanical calibration follows ASTM E2503 and pharmacopoeial requirements.
Q3: What is the warranty period for the whole machine and key components?
A: The whole tester is covered by a 12-month warranty. The drive system, water bath, vessels, controller and sampling system are covered, while paddles, baskets, vessels and filters are consumables or accessories. Damage from improper use or unauthorized repair is excluded. Extended service contracts are available for pharmaceutical QC equipment.
Q4: Is this device difficult to operate? Is professional training required?
A: Operation requires trained pharmaceutical QC or R&D personnel familiar with pharmacopoeial dissolution methods and instrument operation. We provide operation manuals, training and application support. Proper apparatus assembly, degassing of medium, temperature equilibration, sampling technique and result calculation are important for compliant dissolution testing.
Q5: What is the typical lead-time for order delivery?
A: Standard models require 7-30 working days. In-stock units can ship within 3-7 working days. Custom configurations or large built-to-order systems may require additional time, and we confirm the exact schedule before order confirmation.
Q6: Is regular calibration required? What is the recommended calibration cycle?
A: Mechanical calibration (temperature, speed, vessel centering, paddle depth) recommended every 6-12 months per ASTM E2503 and pharmacopoeial requirements. Full apparatus qualification (IQ/OQ/PQ) for GMP facilities. Performance verification with calibrated prednisone or salicylic acid tablets periodically. Daily verification of temperature and speed before use.
Q7: Are supporting consumables universal?
A: Vessels, paddles, baskets, filters and sampling syringes are available from multiple suppliers, though dimensions should match pharmacopoeial and instrument specifications. Long-term consumable cost is moderate depending on testing volume.
Q8: Can I customize parameters or supporting accessories?
A: Customization includes number of vessels, apparatus type, automation level, sampling system, online UV and software features. Additional vessels, paddles and accessories can be ordered separately. Custom orders extend delivery lead-time.
Q9: Does the purchase include on-site installation and commissioning service?
A: Yes, dissolution testers include on-site installation, mechanical calibration, IQ/OQ qualification and operator training by certified specialists for GMP pharmaceutical facilities. Site preparation guidance is provided before delivery to ensure power, water and environmental requirements are met.
Q10: What types of samples are compatible with this equipment?
A: The dissolution tester tests tablets, capsules, granules, powders and other oral solid dosage forms within the vessel capacity and pharmacopoeial specifications. Different dosage forms may require specific apparatus (basket or paddle), medium and speed per the monograph. Modified release formulations may require special media or apparatus. Users should follow the specific pharmacopoeial monograph or validated method, use properly degassed dissolution medium at 37 degrees Celsius, ensure proper apparatus assembly and mechanical calibration, sample at specified time points, and record complete test conditions for GMP compliance and data traceability.
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