2021-10-30

Application Case of RT7 Flow-Through Cell Dissolution System —— Study on In Vitro Release of Long-Acting Sustained-Release Tablets

Sustained and controlled release drug delivery systems has always been one of the key points of domestic drug research and development. It uses sustained and controlled release preparation technology to delay and control the release rate of drugs, so as to improve the curative effect, reduce adverse reactions, prolong the dosing interval and improve the medication compliance of patients. The sustained-release tablets in this study control the release rate of drugs through skeleton materials, so as to achieve the effect of 24-hour long-term sustained-release. In order to obtain more discriminative dissolution test data, the in vitro release of this product will be studied by flow-through cell method. Experimental Method Dissolution Apparatus: Raytor RT7 Flow-Through Cell Dissolution System Flow-Through Cell: 22.6mm inner diameter pharmacopoeia standard flow-through cell Filtration System: Raytor patent flow-through cell online filtration device A 5mm diameter ruby ball is placed at the bottom of the flow-through cell and filled with 1mm diameter glass beads. The tablets were placed on a tablet holder for a flow-through cell with an inner diameter of 22.6mm. In Vitro Release Results The experimental samples include: reference and self-developed sample. The dissolution test was started according to the proposed research method, the sample solution was collected at each sampling time point, and the API concentration was detected by HPLC. Release phenomenon of sustained release tablets on sample support Through the test results, the Average Release Concentration - Time Curve and Dissolution Rate - Time Curve were drawn. The relative standard deviation (RSD) of the final dissolution rate of the reference is 1.38%, and that of the self-developed sample is 2.79%. The repeatability of this test method is good. Average Release Concentration - Time Curve Dissolution Rate - Time Curve Results and Discussion From the experimental results, we can find that the dissolution rate of the reference has been higher than that of the self-developed sample throughout the dissolution experiment. With the continuous release of the drug, the difference in the cumulative dissolution rate between the reference and the self-developed sample gradually increased. Through the concentration-time curves of the reference and the self-developed sample, we can better analyze this phenomenon: the release concentration of the reference is continuously higher than that of the self-developed sample in the prophase and metaphase of the dissolution experiment, and the concentration change of the self-developed sample is more gentle. Their different release behaviors may lead to differences in their bioavailability.

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2021-10-21

Application Case of RT7 Flow-Through Cell Dissolution System —— Study on In Vitro Release of Enteric Coated Sustained Release Capsules

0913 Guidelines for Sustained-release, Controlled-release and Delayed release Preparations in Chinese Pharmacopoeia 2020 edition, it is pointed out that the formulation and process design of sustained-release preparations may affect their quality and efficacy. Therefore, it is necessary to conduct a comprehensive and in-depth study on them and establish an in vitro release test method that can eva1uate the basic situation in vivo. Compared with the traditional dissolution method, the flow-through cell method has the advantages of better biological correlation and discrimination. Therefore, this paper will take the in vitro release study of enteric coated sustained-release capsules entrusted by a customer as an example to share the technical points of the flow-through cell method. Experimental Method Dissolution Apparatus: Raytor RT7 Flow-Through Cell Dissolution System Flow-Through Cell: 22.6mm inner diameter pharmacopoeia standard flow-through cell Mode: Open loop Dissolution Medium: Dissolution medium with multi pH value Filtration System: Raytor patent flow-through cell online filtration device In Vitro Release Results The experimental samples include: reference preparation and three batches of self-developed samples with different production processes. Start the dissolution test according to the proposed research method, collect the sample solution at each sampling time point in the open-loop mode, and detect the API concentration by HPLC. Release phenomenon of reference preparation at different time points For the sake of technical confidentiality, we only show the in vitro release test results in the first 120 minutes of the test process. Among them, 0 ~ 30min is dissolution medium A (pH1.2), and 30 ~ 120min is dissolution medium B. Concentration - Time Curve Dissolution - Time curve As enteric coated capsules, during the acid stage (pH 1.2) of 0 ~ 30min in the in vitro release test, the reference preparation and three batches of self-developed samples basically did not release. However, when the in vitro release test enters the phase of dissolution medium B, the release behavior of the self-developed samples and the reference preparation show very obvious differences: The peak concentration and peak arrival time of No. 1 self-developed sample are close to those of the reference preparation. However, after the concentration of No. 1 self-developed sample reached the peak, it decreased faster than that of the reference preparation. Moreover, in the subsequent stable release period, the concentration level of No. 1 self-developed sample was also lower than that of the reference preparation. The peak arrival time of No. 2 self-developed sample is slower than that of the reference preparation. Although the concentration decline rate is slower than that of No. 1 self-developed sample, its concentration level is still lower than that of the reference preparation in the subsequent stable release period. The peak concentration of No. 3 self-developed sample was much higher than that of the reference preparation. In the stable release period after the peak concentration, the concentration level was close to that of the reference preparation. Result Discussion According to the experimental results, we can find that there may be some defects in the design of three batches of self-developed samples: The concentration of No. 1 self-developed sample decreased rapidly after reaching the peak value, and could not maintain the concentration level equivalent to the reference preparation in the stable release period, which may lead to its bioavailability being lower than that of the reference preparation. The peak arrival time of No. 2 self-developed sample is slower than that of the reference preparation, which may show different clinical data from the reference preparation. The peak concentration of No. 3 self-developed sample was too high, and its release rate at the initial stage was much faster than that of the reference preparation. At the same time, it may be difficult to maintain the concentration level equivalent to the reference preparation in the middle and late stage of release, which is not in line with the design idea of a sustained-release preparation. According to the in vitro release test results of flow-through cell method, we can clearly observe the differences between the samples of three different production processes and the reference preparations, and preliminarily predict the differences in their bioavailability, so as to provide more scientific and effective data for the improvement of prescr1ption process design

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2021-10-14

Invitation of Raytor Lecture - "Dissolution Process of Soft Capsule in Gastrointestinal Tract by Dissolution Prediction"

Time: Monday, November 8, 2021Location: Raytor Instruments Knowledge Store (online) Registration method: code scanning registration (company / name / contact information) Course Introduction With the promotion of 4 + 7 volume procurement, the price of traditional generic drugs has been falling all the way. More and more pharmaceutical enterprises choose soft capsule as an innovative dosage form to improve the bioavailability of insoluble drugs, user experience and enhance their own profitability. In this course, Raytor will take soft capsule as the representative dosage form, study the dissolution behavior of dosage form in human body by flow cell biological dissolution method, and provide innovative dissolution solutions for domestic scientific researchers. The main contents of this course include: 1. Characteristics and commercial value of innovative preparation soft capsule. 2. Structure and manufacture of soft capsules. 3. Prediction of human utilization of soft capsules.4. How to realize the transfer from R&D methods to quality control methods. Course Arrangement 19:30~20:30:The dissolution process of soft capsule in gastrointestinal tract  eva1uated by dissolution prediction.20:30~21:00:Answering question. Trainer Introduction Jacky Lu Technical director of Raytor Instruments, graduated from the Department of Biochemistry of Sun Yat Sen University, has worked in Takeda, Baxter, Pharmdex and other multinational enterprises for more than 10 years, and has a deep understanding of drug analysis and drug quality research. At present, he is also the main drafter of the flow-through cell chapter of the dissolution series of the Central Inspection Institute (not yet published to the public).

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2021-09-19

DIQC2021 - Drug Quality Control and Inspection Technology Forum

Raytor Instruments and its Hebei regional partner Zhongyi Yinghe participated in DIQC2021 - Drug Quality Control and Inspection Technology Forum hosted by Hebei Pharmaceutical Association and Hebei Pharmaceutical Industry Association on September 17-18, 2021. The content of this meeting is very wonderful, such as: Li Hongye, from the certification center of the National Medical Products Administration, made a profound interpretation of the measures for the administration of post marketing changes of drugs issued by the National Medical Products Administration. Zhang Jieping, chief pharmacist of Beijing Institute of Drug Control, explained the interpretation of the 2020 edition of Chinese Pharmacopoeia and its application in drug quality analysis at the meeting. Professor Wang Qiao of the school of pharmacy of Hebei Medical University shared the subject of drug analysis method establishment and quality eva1uation. As the first manufacturer of domestic flow-through cell dissolution system, Raytor Instruments, together with RT7 flow-through cell dissolution system and RT6 series dissolution system , attended the meeting, which won great attention from the participating teachers. The booth of Raytor Instruments was crowded, and many teachers were listening to technicians explain the characteristics of Raytor dissolution system. Raytor's RT7 flow-through cell dissolution system, which can study the in vitro release of complex preparations such as liposomes, microspheres, soft capsules, long-term sustained release and ointment, has attracted more attention from many researchers present. Many teachers stopped in front of the equipment to understand the application of flow-through cell method. Raytor Instruments, represented by Jacky Lu, shared with the majority of researchers how to predict the release behavior of drugs in the human body through physiologically related dissolution experiments in the process of drug R&D. The new research ideas were affirmed by the participating teachers, and the teachers present listened carefully to the relevant contents. After the speech, many teachers came to the booth of Raytor Instruments to discuss with us more about the correlation between biological prediction experimental scheme and be. Thank you for your support and affirmation of Raytor Instruments. Raytor Instruments will strive to complete more research on the application of flow-through cell method, and share more biological prediction content for R&D in the next CIS-Asia2021 12th International Chemical Pharmaceutical Summit - Asia. Please pay attention to our theme report at Fengda International Hotel, Beijing, China.

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2021-09-15

UV Online Automatic Detection Dissolution System

RT600-UV UV Online Automatic Detection Dissolution System is the latest product launched by Raytor Instruments based on the third generation dissolution operating system. RT600-UV dissolution system includes dissolution apparatus, automatic sampling workstation and UV-Vis spectrophotometer. RT600-UV supports automatic dissolution sampling and automatic UV online detection, which is more convenient for drug research and development and routine detection, and greatly improves work efficiency. (1) Each dissolution vessel has an independent sample colorimetric flow cell and pipe to effectively avoid cross contamination between samples of different dissolution vessels. (2) The dissolution operating system controls the automatic dissolution apparatus, automatic sampling workstation and UV-Vis spectrophotometer, and supports the preset and call of the dissolution UV online automatic detection method. The dissolution system will automatically complete the automatic dissolution sampling and automatic online UV detection according to the preset method. The test results will be fed back to the interface of the dissolution operating system in real time and automatically monitored Automatically generate protected electronic data d0cuments in real time. (3)Raytor's advanced dissolution operating system can ensure full compliance with data integrity requirements, audit tracking requirements, account management requirements and other regulatory requirements. Raytor UV online automatic detection dissolution system has excellent accuracy and stability, and can ensure the accuracy and stability of test results even in the face of harsh test conditions. Accuracy Thanks to the advanced automatic sampling technology of Raytors Instruments, the accuracy of RT600-UV dissolution system can reach a high level. Excellent accuracy can ensure that the UV online test can truly reflect the real-time dissolution of samples, and the test results are more real and reliable. Test Case: Performed manual sampling test and UV online test respectively, and the continuous detected the salicylic acid solution with the concentration of 6, 9, 12,18, 24,36 μg / ml. Taking salicylic acid concentration as X axis and sample absorbance (Abs) as Y axis, established a linear regression curve, and calculated the R square value of each curve was. The results of UV online test showed excellent linear correlation, and the R square value was 0.9995, which had no significant difference from the manual sampling control group (0.9999). Established a linear regression curve using the absorbance (Abs) of the manual sampling control group as the X-axis, and the absorbance (Abs) of the UV online test group is the Y-axis. Its R square value is 0.9996. The results show that Raytor online UV automatic detection dissolution system has excellent accuracy. Repeatability The test results need not only accuracy, but also repeatability. Raytor UV  online automatic detection dissolution system has excellent repeatability to ensure that the UV online test results of continuous automatic sampling are stable and reliable. Test Case: Use RT600-UV dissolution system to continuously perform on-line sampling for 10 times for the sample solution of the same concentration (each sampling interval is 5 minutes). For example, in the sample test group with lower concentration, the relative standard deviation (RSD) of 10 test results is 1.2%, and the difference between the average absorbance of UV online test (0.2916) and that of manual sampling test (0.2904) is 0.4%. The test results fully show that Raytor UV online automatic detection dissolution system has excellent accuracy and stability at the same time. Multichannel UV Online Detection Raytor UV online automatic detection dissolution system can connect 8-channel UV online detection pipe at the same time. Among them, 6 channel pipes are used for online detection of sample dissolution rate, 1 channel pipe is used for blank calibration, and 1 channel pipe is reserved for reference test. Through the operating system, the automatic dissolution test procedure of "drug dosing → test running → sampling →  UV detection" can be simply realized, and the experimental efficiency can be greatly improved. Test Case: Perform dissolution test by using the RT600-UV dissolution system with dissolution parameters as : Basket method; Speed: 100RPM; Dissolution medium: 900ml pure water; Temperature: 37.0 ℃; UV detection wavelength: 257nm. After the automatic synchronous dosing of the sample, the system will automatically sample every 5 minutes and perform UV online detection. The concentration of the sample solution is converted through the absorbance results, and the dissolution rate is further obtained. The test results of sample dissolution rate are as follows: The UV online detection results of different channels are in good agreement, and the sample dissolution can be presented accurately and in real time. Raytor UV online automatic detection dissolution system makes the drug dissolution test more accurate, convenient and efficient.

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2021-09-14

Application Case of RT7 Flow-Through Cell Dissolution System —— Effect of Surfactants on Drug Dissolution Curve

In the development of dissolution methods, it is usually necessary to determine the minimum concentration of surfactant required to reach the sink conditions. For traditional dissolution methods, the volume of dissolution medium is generally more than 3 times that of drug saturated solution. On this basis, the minimum concentration of surfactant can be determined relatively simply. However, for the flow-through cell dissolution method, the drug is released in a small volume of the flow-through cell, and the volume of dissolution medium contacted in unit time is affected by the flow rate. The eva1uation of surfactants cannot be as simple as the traditional dissolution method. This case selects the eva1uation results of the impact of different concentrations of sodium dodecyl sulfate (SDS) on the sample dissolution curve during the development of flow-through cell dissolution method for our customers, hoping to bring you help and inspiration. Test Conditions Flow-Through Cell: 22.6mm inner diameter standard flow-through cell. Flow Rate: the same flow rate is used for parallel testing. SDS Concentration:0.1%、0.2%、0.5%、1.0%(wt/volume)。 Place a 5mm diameter ruby ball at the bottom of the flow-through cell, then fill it with 1mm diameter glass beads, and place the sample on the glass beads. Test Result The dissolution curves of samples under different SDS concentrations are shown in the figure: The test results show that: In the range of 0.1% - 0.5% SDS concentration, the release rate and final dissolution increased with the increase of SDS concentration. When the SDS concentration is greater than 0.5%, the rise of SDS concentration will no longer have a significant impact on the dissolution curve of the sample. Therefore, we can preliminarily determine that 0.5% is the minimum concentration of SDS required to reach the sink condition under the current test conditions. Considering the discrimination of dissolution method, the use of dissolution medium with SDS concentration greater than 0.5% may lead to poor discrimination of dissolution method for different samples, and the solubilization effect of high concentration surfactant may "erase" the difference of dissolution results between different samples. Moreover, the high concentration of surfactant will affect the normal service life of the chromatographic column. Therefore, during the development of dissolution method, it is generally not recommended to increase the concentration of surfactant on the premise of ensuring that the solubility of API meets the demand. On the other hand, the use of dissolution media with SDS concentration less than 0.5% may lead to insufficient dissolution of samples. From the perspective of method development, the use of surfactants with a concentration lower than that required for sink conditions is indeed not a good choice.  However, from the perspective of research, some literatures point out that appropriately reducing the solubility of dissolution medium can improve the discrimination of dissolution methods to a certain extent, which also has enlightenment on how to select appropriate concentration surfactants in the process of method development.

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2021-09-08

Mechanical Calibration Workstation for Paddle, Basket and Mini Vessel Method

RT260 Dissolution Apparatus Mechanical Calibration Workstation Raytor RT260 Dissolution Apparatus Mechanical Calibration Workstation is applicable to the mechanical calibration of standard ordinary dissolution apparatus by paddle method, basket method and mini vessel method. Relevant tools meet the calibration standards of Metrology Institute and the requirements of current Chinese Pharmacopoeia, US Pharmacopoeia and European Pharmacopoeia. The calibration data of test tool can be wirelessly transmitted to the intelligent detection workstation (handheld tablet PC) in real time, and the test report can be generated automatically. There is no need to record the data manually in the whole process. Data recording is real-time and accurate, meeting the requirements of data integrity. Calibration Test Items It is equipped with  a variety of high-precision measurement modules certified by measurement institutions to meet the needs of the following calibration items: shaft wobble, basket wobble, shaft verticality, vessel/shaft centering, vessel verticality, height check/basket depth, rotational speed, temperature uniformity in dissolution vessels, etc. Main Components Intelligent Detection Workstation Digital Gradienter Tachometer Digital Thermometer Centering & Wobble Meter Depth Meter Wireless Relay & Transmitting Module Operating System The advanced operating system includes a variety of practical functions: creating / continuing calibration test items, retrieving and consulting the executed calibration test results, exporting calibration data (PDF d0cument), account management, login password protection, etc.

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2021-09-08

RT800 Automatic Sampling Transdermal Diffusion System

Raytor RT800 Automatic Sampling Transdermal Diffusion System meets the requirements of USP < 1724 >, which is used for drug transdermal release test of ointment, hard paste, coating, lotion, membrane, aerosol and other preparations, and studies the efficiency of drug transdermal absorption through the skin through the model of percutaneous absorption. RT800 Automatic Sampling Transdermal Diffusion System has advanced automatic sampling technology, which can complete the exhaust bubble, sample sampling, sample collection, medium replenishment, and sample probe cleaning, making the drug transdermal release test more accurate and efficient.. RT800 Automatic Sampling Transdermal Diffusion System User-Computer Interface The 8.4-inch touch screen is pre installed with Raytor dissolution operating system, which meets the requirements of data integrity. High Precision Sampling Pump Sampling error <± 0.1mL. Automatic rinse before sampling and automatic cleaning after sampling ensure sampling accuracy and avoid residue. Dry Heat Constant Temperature Stirring Device High precision  temperature heating and stirring function. The automatic sampling experiment of 7 diffusion cells on both sides (14 in total) can be carried out simultaneously. Automatic Positioning Sampling Needle The sampling needle can be automatically positioned and tilted into the diffusion cell for automatic sampling. After that, it can collect the sample solution, and replenish the medium automatically. Sample Collection Rack The system is suitable for 10ml tube rack and liquid phase vial rack, and the system will automatically collect the sample solution into the tube or liquid phase vial. Replenishment & Cleaning Trough The sampling needle automatically extracts fresh medium and replenishes it into the diffusion cell. After completing a sampling process, the sampling needle will perform automatic cleaning. Improved Franz Vertical Diffusion Cell Raytor improved Franz vertical diffusion cell is more portable and durable, and the unique sampling arm design makes the sampling process more convenient and smooth. The volume of the medium in the diffusion cell can be adjusted by using stirring bar with different heights.  Flexible Sampling Method Users can set the method to control the system for automatic sampling, or manually use the pipette for sampling. Automatic Sample Collection After sampling, the sampling needle will automatically move to the designated position of the sample collection rack to collect the sample solution into a 10ml test tube or liquid vial. It can support the sample collection of 7 diffusion cells on both sides at the same time. Automatic Cleaning Sampling Needle After sample collection, the sampling probe will be automatically moved to the cleaning trough, cleaned with fresh and flowing medium, and wait for the next sampling. The Operating System Fully Compliant with Data Integrity  Software System: the software system is simple to operate and easy to use; At least 200 dissolution test methods can be stored; The storage capacity of the system can meet the record storage for at least 10 years. User Authority Management: at least 100 login accounts can be preset and protected by user login password; At least 3 kinds of user permissions can be assigned (system administrator, laboratory supervisor and experimental analyst); Users can flexibly customize the permission details of various permission levels according to their own risk assessment. Audit Track: the audit track function specific to individual accounts at all levels, including login records, experiment records, operation records, cleaning records, etc. Electronic Data Integrity: accurate and consistent electronic data can be generated synchronously during experiments. Each experiment will automatically generate corresponding experimental records and support PDF format export. Experimental records and all records of the system can be retrieved, exported, backed up and printed. All electronic data are protected from arbitrary tampering and deletion.

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2021-09-02

Manual Sampling Reciprocating Cylinder Dissolution Apparatus

Raytor RT3 Reciprocating Cylinder Dissolution Apparatus Raytor RT3 Reciprocating Cylinder Dissolution Apparatus has stable performance and fully meets the requirements of Chinese Pharmacopoeia, US Pharmacopoeia and European Pharmacopoeia for reciprocating cylinder dissolution test. RT3 is equipped with 7 reciprocating cylinder units and 6 rows of dissolution vessels. It can use a variety of dissolution media with different pH at the same time to effectively simulate the human gastrointestinal environment. At the same time, RT3 has advanced automation design, including automatic replacement of dissolution medium and automatic opening of dissolution vessel cover, which makes the dissolution experiment more efficient and accurate. Reciprocating Lifting Motor The reciprocating rate (4 ~ 60 DPM), reciprocating stroke (2 ~ 10 cm), immersion time and drain time can be set. Automatic Displacement Motor According to the time interval set by the method, it will automatically transfer the reciprocating cylinder to the next row of dissolution vessel. Automatic Dissolution Vessel Cover The cover of dissolution vessel can automatically open and close, effectively reduce the evaporation loss of the dissolution medium. Reciprocating Cylinder Rack Clean the used reciprocating cylinders and place them on the rack for drying, which is convenient for the next experiment. Automatic Positioning Sampling Needles According to the volume of dissolution medium set by the method, the sampling needles will automatically position to the midpoint from the bottom of the vessel to the liquid level. Reciprocating Cylinder Mounting Bracket The coaxial split design makes it quickly to replace the reciprocating cylinder with other reciprocating holder. User-Computer Interface 8.4-inch touch screen, pre installed with the Raytor dissolution operating system, meeting the data integrity requirements. Integral Moulding Water Bath Integrated moulding and rounded angle design, no cleaning dead angle, water bath can be completely drained. Flexible Sampling Scheme  RT3 provides flexible sampling scheme. Even if there is no automatic sampling workstation, the user can perform the manually sampling through thesampling hole on the dissolution apparatus. The Operating System Fully Compliant with Data Integrity  Software System: the software system is simple to operate and easy to use; At least 200 dissolution test methods can be stored; The storage capacity of the system can meet the record storage for at least 10 years. User Authority Management: at least 100 login accounts can be preset and protected by user login password; At least 3 kinds of user permissions can be assigned (system administrator, laboratory supervisor and experimental analyst); Users can flexibly customize the permission details of various permission levels according to their own risk assessment. Audit Track: the audit track function specific to individual accounts at all levels, including login records, experiment records, operation records, cleaning records, etc. Electronic Data Integrity: accurate and consistent electronic data can be generated synchronously during experiments. Each experiment will automatically generate corresponding experimental records and support PDF format export. Experimental records and all records of the system can be retrieved, exported, backed up and printed. All electronic data are protected from arbitrary tampering and deletion.

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2021-09-02

8 Vessels Automatic Sampling Dissolution System

Raytor RT600-AT Automatic Sampling Dissolution System Raytor RT600-AT Automatic Sampling Dissolution System includes: Raytor RT600 Dissolution Apparatus and Raytor Dissolution Automatic Sampling Workstation. Raytor RT600 Dissolution Apparatus is a high-performance 8 vessels dissolution apparatus newly designed and manufactured in accordance with the requirements of Chinese Pharmacopoeia, USP Pharmacopoeia and guiding principles for mechanical verification of drug dissolution apparatus. It has accurate mechanical parameters, stable performance, and has an operating system that fully meets the data integrity, which is suitable for various standardized dissolution tests. Raytor Dissolution Automatic Sampling Workstation is equipped with 8 channel high-precision Raytor injection pump or plunger pump (one of the two), which also serves as paddle method, basket method and small vessel method. It can effectively provide accurate automatic sampling at each time point, reflecting the advantages of high efficiency, accuracy, stability and easy use of software. Automatic Synchronous Dosing The automatic dosing module can realize the automatic synchronous dosing of all samples, and the dosing time point can be recorded and audited by the system. After dosing, the sampling time will be timed automatically, and a prompt will sound before reaching the sampling time point. Flexible and Accurate Sampling Automatic positioning of sampling position: the system automatically locates the sampling position of the sampling needle according to the preset experimental method (basket method / paddle method, etc.) and the volume of dissolution medium. The non resident sampling needle reduces the generation of disturbance of dissolved medium during the test. Flexible sampling mode, supporting automatic sampling and manual sampling: Automatic Sampling: when an automatic sampling workstation is configured, automatic sampling can be carried out at the preset sampling time point through the automatic sampling workstation. Manual Sampling: manual sampling can be carried out through the sampling port reserved on the anti evaporation cover, or manual sampling can be carried out by using the automatic positioning sampling needle. Patent Design of Common Shaft for Paddle and Basket The dissolution stirring parts of basket method, paddle method and small vessel method are designed in common shaft. The dissolution stirring parts such as basket method / paddle method can be switched freely on the same rotating shaft without repositioning, which is accurate and convenient and saves a lot of experimental time. The connection between the dissolution stirring part and the rotating shaft is located above the liquid level of the dissolution medium, which is easy to clean and has no residual risk. The dissolution stirring parts are made of 316L stainless steel and have special anti-corrosion coating treatment, which can effectively deal with various experimental conditions. Edge Wrapped Design of Dissolution Vessel The edge of the Raytor dissolution vessel adopts an innovative edge wrapping design, which effectively avoids the possible collision damage of the dissolution vessel during use, making the dissolution vessel more durable. Quick and accurate installation of dissolution vessel: align the three convex buckles of dissolution vessel with the three concave positions of the hole on the base of the installation platform, put it into the dissolution vessel, and rotate it clockwise for 30 ° to complete the installation. The traditional fixed spring buckle of dissolution vessel is eliminated, and the integrated and flat installation platform of dissolution vessel is very convenient for cleaning.   Advanced Mechanical Component Design The driving head adopts intelligent automatic lifting mode: the dissolution apparatus drives the head to lift accurately and reliably to ensure that the key experimental parameters such as the height and center position of the shaft have high accuracy and reproducibility. The high-definition wide touch screen clearly presents the experimental process and test parameters for easy operation. The non resident temperature probe monitors the temperature of the dissolved medium at each preset sampling time point. The water bath adopts integrated fillet design: the water bath cycle has no dead corner and constant temperature ability; There is no cleaning dead corner, and the water bath drain is located at the bottom of the water bath, which can ensure that the water bath can be completely drained. Automatic Sampling Workstation More than 20 automatic sampling points can be set, and the sampling volume can reach 20ml, meeting all dissolution requirements. Teflon sampling pipeline with high chemical stability and high adsorption resistance is adopted to avoid corrosion or adsorption of pipe. Before sampling, moisten the sampling pipe and return pipe to make the sample concentration more accurate. After sampling, purge and empty the residual liquid in the sampling pipe, return pipe and sample injection needle to make the sampling volume more accurate. Secondary on-line filter can be installed (e.g. 0.45 μm filter), the instrument can automatically realize two-stage on-line filtration. It has the function of automatically replenishing medium and automatically cleaning pipe. The Operating System Fully Compliant with Data Integrity  Software System: the software system is simple to operate and easy to use; At least 200 dissolution test methods can be stored; The storage capacity of the system can meet the record storage for at least 10 years. User Authority Management: at least 100 login accounts can be preset and protected by user login password; At least 3 kinds of user permissions can be assigned (system administrator, laboratory supervisor and experimental analyst); Users can flexibly customize the permission details of various permission levels according to their own risk assessment. Audit Track: the audit track function specific to individual accounts at all levels, including login records, experiment records, operation records, cleaning records, etc. Electronic Data Integrity: accurate and consistent electronic data can be generated synchronously during experiments. Each experiment will automatically generate corresponding experimental records and support PDF format export. Experimental records and all records of the system can be retrieved, exported, backed up and printed. All electronic data are protected from arbitrary tampering and deletion.

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