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    Home > Active Ingredient News > Drugs Articles > How to choose drug stability test chamber?

    How to choose drug stability test chamber?

    • Last Update: 2019-03-14
    • Source: Internet
    • Author: User
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    The purpose of stability test is to investigate the change rule of API or pharmaceutical preparation with time under the influence of temperature, humidity and light, so as to provide scientific basis for the conditions of production, packaging, storage and transportation of drugs, and establish the validity period of drugs through the test The basic requirements of stability test are: 1) stability test includes influencing factor test, accelerated test and long-term test The influencing factors were tested with one batch of APIs Accelerated test and long-term test are required to be conducted with 3 batches of test articles 2) In order to study the stability of drugs, we should adopt the methods of drug analysis with strong specificity, accuracy, precision and sensitivity, and the methods of inspection of related substances (including degradation products and products generated by other changes), and verify the methods, so as to ensure the reliability of drug stability test results In the stability test, we should pay attention to the inspection of degradation products How to choose the stability test chamber of drugs? Zui is important to be able to meet the requirements of ICH regulations related to drugs (including APIs or pharmaceutical preparations) and Pharmacopoeia of the people's Republic of China (2015 version, Part 4 or later) 1 Influence factor test this test is conducted under more intense conditions than accelerated test The purpose of this study is to explore the inherent stability of drugs, understand the factors affecting their stability, possible degradation pathways and degradation products, and provide scientific basis for the production process, packaging, storage conditions and the establishment of analysis methods of degradation products Generally, it includes high temperature, high humidity and strong light irradiation test Generally, the test substance of API is placed in a suitable open container (such as a measuring bottle or Petri dish), spread into a thin layer of ≤ 5mm thick, and the loose API is spread into a thin layer of ≤ 10mm thick for test For oral solid preparation products, it is generally used to remove the small Zui preparation units from the inner packaging and disperse them into a single layer under suitable conditions If the test results are not clear, two more batches of samples shall be tested 1 Place the opening of the high-temperature test sample in a suitable clean container, place it for 10 days at 60 ℃± 2 ℃, and take samples on the 5th and 10th day to test the relevant indicators If there is significant change in the test article, the test shall be conducted in the same way at 40 ℃ ± 2 ℃ If there is no significant change at 60 ℃, 40 ℃ test is not necessary 2 The high humidity test sample shall be placed in a constant humidity closed container at 25 ℃ for 10 days under the conditions of 75% ± 5% and 90% ± 5% relative humidity respectively, and the samples shall be taken for detection on the 5th and 10th day The test items shall include moisture absorption and weight increase items This test is not required for liquid preparations Binder KMF series phase diagram 3 Place the opening of the test sample in the light box or other suitable light container, and place it for 10 days under the illumination of 4500lx ± 500lx (the total illumination measurement is 1.2 million LxH) Take samples on the 5th and 10th day for testing, and use ultraviolet light if possible The total illumination of the light test shall not be less than 1.2 × 106 lux · HR, and the near ultraviolet energy shall not be less than 200 W · HR / m2 II Accelerated and long-term test: the Zui short-term and long-term test covered by the application data of placement conditions of the accelerated and long-term test research project 25 ℃± 2 ℃ / 60% RH ± 5% RH or 30 ℃± 2 ℃ / 65% RH ± 5% RH new preparation 12 months imitation preparation 6 months intermediate test 30 ℃± 2 ℃ / 65% RH ± 5% RH 6-month accelerated test 40 ℃± 2 ℃ / 75% RH ± 5% RH 6-month storage conditions of preparation research project to be refrigerated Zui short-term long-term test covered by the declared data 5 ℃± 3 ℃ 12-month accelerated test Zui short time covered by the application data of storage conditions of the preparation research project to be frozen for 6 months at 25 ℃± 2 ℃ / 60% RH ± 5% RH Long term test - 20 ℃± 5 ℃ 12 months accelerated test 5 ℃± 3 ℃ or 25 ℃± 2 ℃ 6 months According to the nature of drugs, users can choose the following models of constant temperature and humidity boxes During the accelerated test, samples shall be taken at the end of the first month, the second month, the third month and the sixth month respectively, and tested according to the key inspection items of stability; in the long-term test, samples shall be taken every three months, respectively at 0 month, 3 month, 6 month, 9 month and 12 month, and tested according to the key inspection items of stability This requires constant temperature and humidity test chamber to adopt compressor refrigeration technology instead of semiconductor technology to ensure short recovery time of opening and closing door When your drugs, biomedical related devices or information systems need to be sold to pharmaceutical companies and researchers in the United States, they should comply with FDA 21 CFR Part 11 Corresponding GLP software system conforming to FDA 21 CFR Part 11 shall be selected The stability test chamber used in stability shall be verified (IQ, OQ, PQ) or verified to be qualified The corresponding verification scheme and report shall be complete The management of stability test chamber shall be regulated by SOP Who is responsible for daily inspection? Who has access to the stability lab? Who is responsible for filling in the records (sample placement, sample taking out), in case of sudden power failure, water shortage, water leakage, lack of printing paper, humidity overrun How to deal with these problems, whether there are emergency measures and plans, such as UPS power supply All work to ensure that the samples are placed under normal conditions should be considered in place Constant temperature and humidity box, as a star product of binder, has entered the Chinese market for many years, accumulated a broad user base and enjoyed a high reputation The new generation constant temperature and humidity box is equipped with a large touch control panel, which is convenient for users to adjust and monitor the experimental data in real time For the sake of data information security, we also set up a series of security settings, such as password lock and hierarchical management "Create a good Zui condition for your success" is the concept of binder, which is committed to providing customers with products, services and professional consulting In China, binder's constant temperature and humidity box has always been favored by the majority of users The sales volume of constant temperature and humidity box accounts for 50% of binder's total sales volume in China, once reaching 80% market share in China In terms of product strategy, binder has always been the brand image, and has always been in the leading position in the pharmaceutical market The pharmaceutical industry has strict requirements on the products of constant temperature and humidity boxes.
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