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Solution for residual solvent detection in drugs
Date: 2016-12-12Read: 1

Due to the inevitable use of organic solvents in the purification, extraction, and production processes of drugs, if these solvents exceed the standard, they can seriously harm people's health when ingested into the human body.

From the analysis of residual organic solvents in the drugs to be tested according to national standards, there are mainly three categories:

One is to eliminate the use of solvents. This type of solvent poses significant risks such as carcinogenicity and teratogenicity, and should be avoided during drug use. This type of solvent cannot be detected.

The second is solvents with limited values. This type of solvent can be used, but sufficient post-treatment is required to remove it. The test results only need to meet the national standards.

The three types are low toxicity solvents, which have relatively high limit values. Generally, it is a low toxicity solvent, such as ethanol, acetic acid, etc.

The gas chromatography system is generally used to analyze these residual solvents. According to the requirements of national standards, direct liquid injection or headspace injection can be selected.

From a trend perspective, this type of analysis faces the following challenges:

One reason is that with the advancement of technological means and the improvement of people's health awareness, national standards are becoming increasingly strict, and the limit values are getting lower and lower. Secondly, as the limit values become lower and lower, the requirements for the stability of the detection results become increasingly stringent.

RESTEK provides a complete set of high-quality products for solvent residue detection.

Sample injection system - high inertia liner ensures that each sample is free of any adsorption during each injection.

The separation system - low loss, long lifespan, and high stability gas chromatography column ensures the accuracy and stability of trace analysis.

Retek provides commonly used consumables for various brands of chromatographs, with quality reaching or even exceeding that of original products.