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Analysis of the Role of Differential Scanning Calorimetry in the Study of Drug Stability

2021-01-19
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Differential scanning calorimetry (DSC) is a thermal analysis method developed on the basis of differential thermal analysis (DTA). It can measure the power difference and temperature input to the sample and the reference under the program control temperature This method can be used to study the stability of solid drugs. In my country, DSC is also one of the methods used in the drug quality evaluation system. For example, in the field of drug analysis and testing, this method can be used for drug analysis and thermal analysis of other inorganic and organic compounds.

Differential scanning calorimetry is simple to operate, easy to calibrate, less sample amount, and does not require any pre-treatment of samples. It is a fast and reliable analytical technique, especially suitable for high-purity drug purity determination. DSC technology has also been widely used in many fields. In the field of drug analysis and detection, DSC can be used in many aspects of drug analysis such as purity determination, crystal form identification and melting point detection.

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If compared with other purity determination methods, the DSC method determines the total amount of impurities. There is no need to separate and identify impurities. It does not rely on reference material calibration. It is fast and simple. If the conditions are selected appropriately, the data obtained is accurate and reliable. In terms of crystal form identification, the DSC test is simple and convenient to operate and has high accuracy, so it is used as a common crystal form analysis method in laboratories. Melting point is one of the important indicators for evaluating the quality of medicines. The DSC method is accurate, fast, and reproducible. It can also objectively record the entire melting process. Therefore, the DSC method shows its unique advantages in detecting the melting point.

The study of drug thermal stability and thermal decomposition process is of great significance to drug stability and drug storage validity period. Differential scanning calorimetry can also be used as a method of drug stability test research. Amorphous is a thermodynamically unstable system, and its inherent metastable state causes substances to easily release energy, and it is easy to transform into stable crystals during storage and dissolution. For example, the establishment of differential scanning calorimetry for the determination of amorphous nifedipine, the investigation of the influence of humidity and temperature on the phase transition of amorphous nifedipine, the stability of amorphous nifedipine can be discussed.

Drug stability test is to investigate the law of raw materials or preparations changing with time under the influence of temperature, humidity, light and influence. It can provide scientific basis for the production, packaging, storage and transportation conditions of drugs, and at the same time establish the validity period of drugs through experiments. Medicilon provides drug stability testing services, which can provide customers with research on the stability of global drug registration, experimental/exploratory stability (pre-test) and drug stability after approval.

Some researchers have used differential scanning calorimetry to investigate the thermal stability of antibody-conjugated drugs, and analyze the thermal stability changes of ADC drugs before and after coupling and the differences in thermal stability under different solution conditions, which is the screening of formulations. Provide reference [1]. Through DSC thermal stability, small molecule shedding ratio, SEC-HPLC purity, antigen-binding activity and other indicators, the trastuzumab antibody conjugates are tested at different pH, different concentration and different types of buffer salts, different concentrations and different types of protective agent conditions Undertake accelerated stability investigation. The results of the study found that DSC as a rapid stability inspection method can quickly narrow the screening range, but under different pH conditions, the overall thermal stability trend of the antibody-conjugated molecule is inconsistent with the stability trend of the linker.

In drug stability test research, the DSC method can be combined with other thermal analysis methods to judge the thermal stability of the drug and calculate the storage period of the drug, which is conducive to saving samples and reducing time. The DSC method also has its own limitations in drug analysis and testing. Therefore, it is necessary to give full play to the characteristics of the DSC method and comprehensively apply various other analytical techniques such as chromatography and spectroscopy to ensure that the results of drug quality research and analysis are more accurate and Scientific and credible.

[1] The application of differential scanning calorimetry in the stability study of antibody-conjugated drugs [J].

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