◇ Compound water solubility and stability test method: HPLC-UV
◇ Compound test method development
◇ Method confirmation (to do quantitation limit, linearity and precision)
◇ Solubility test
◇ Stability test
◇With or without compound
◇Different according to the difficulty of the method and the type of solvent
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(1) The content and test design of the stability study
Stability research is an important part of the quality control research of APIs or preparations. It is to design a series of tests to reveal the stability characteristics of APIs and preparations. Stability tests usually include influencing factor tests, accelerated tests and long-term tests. The influencing factor test is mainly to investigate the stability of APIs and preparations to light, humidity, heat, acid, alkali, oxidation, etc., to understand their sensitivity to light, humidity, heat, acid, alkali, oxidation, etc., and the main degradation pathways And degradation products, and provide a reference for further verification of the specificity of the analytical method used, determination of the placement conditions of the accelerated test, and selection of suitable packaging materials. The accelerated test is to investigate the stability of the drug substance or preparation under conditions of long-term storage temperature and humidity. It provides a basis for the design of the prescription process and whether it deviates from the actual storage conditions to maintain the quality stability. Stability test under conditions and determine the placement conditions for long-term tests The long-term test is to investigate the stability of the drug substance or preparation under the planned storage conditions, and to provide data support for confirming the packaging, storage conditions and the validity period/re-examination period.
For ready-to-use preparations, or preparations with a certain period of use after multi-dose packaging is opened, compatibility stability tests or stability tests after opening should also be conducted according to their specific clinical use.
The stability test design should be carried out around the corresponding test purpose. For example, the light test of the influencing factor test is to investigate the light sensitivity of the drug substance or preparation. Usually, the sample should be removed from the package; if the test results show excessive degradation, the surroundings caused by the light source should be excluded first. Degradation caused by the increase in ambient temperature, so parallel samples that are protected from light can be added as a control to eliminate the influence of other factors other than light irradiation on the test results. In addition, samples with inner packaging (or even inner packaging plus outer packaging if necessary) should be used for testing to investigate the protective effect of the packaging on light.
(2) Requirements for stability test samples and considerations for the setting of inspection projects
The samples of the stability test should be representative. The stability test of the registration of APIs and preparations should generally be carried out using at least pilot scale batches of samples. The synthesis route, prescription and production process should be consistent with the commercially produced products or the key process steps of the commercially produced products. The quality of the sample should be consistent with the quality of the commercially produced product; the packaging container should be the same as or similar to the commercially produced product.
Influencing factor test usually only needs 1 batch of samples; if the test result is not clear, 2 batches of samples should be tested. Accelerated test and long-term test are usually carried out with 3 batches of samples.
The investigation items of the stability test should reflect the changes in product quality, that is, those that are prone to change during placement, which may affect their quality, safety, and/or effectiveness, and should cover physical, chemical, biological, and Characteristics of microbiology. In addition, according to the test conditions such as high humidity or high temperature/low humidity, items such as moisture absorption and weight loss or water loss should be added.
The inspection items of APIs usually include: traits (appearance, optical rotation or specific rotation, etc.), acidity and alkalinity, solution clarity and color, impurities (process impurities, degradation products, etc.), enantiomers, crystal form, particle size , Loss on drying/moisture, content, etc. In addition, investigation items should be set up according to the specific situation of the species; such as the viscosity, molecular weight and molecular weight distribution of the polymer; bacterial endotoxin/pyrogen of the sterile API, sterility, visible foreign matter, etc.
The investigation items of preparations usually include: characters (appearance), impurities (degradation products, etc.), moisture and content. In addition, indicators that reflect its quality characteristics should be set according to the characteristics of the dosage form; such as the dissolution of solid oral preparations, the release of sustained and controlled release preparations, enteric preparations, transdermal patches, and the mist droplets (granules) of inhaled preparations Distribution, encapsulation rate and leakage rate of liposomes.
In addition, the migration test and adsorption test of the compatibility study of the preparation and the packaging material or container are usually through the acceleration and/or long-term stability test (note that the drug should be in full contact with the packaging material) to increase the corresponding potential target leaching, functionality Test indexes such as the content of excipients, and obtain the adsorption data of the extracts and packaging materials contained in the drugs to the pharmaceutical ingredients; therefore, the stability test of high-risk preparations (inhalation preparations, injections, eye drops, etc.) should be considered with the packaging materials or The compatibility test of the container is designed together. For the specific content and test methods of the compatibility study, refer to the technical guidelines for the compatibility study of drugs and packaging materials or containers.
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