GB/T 35951-2018 in English

GB/T 35951—2018 Standard Overview

GB/T 35951—2018 "Determination of 8 Macrolide Antibiotics including Spiramycin in Cosmetics by Liquid Chromatography-Tandem Mass Spectrometry" specifies the detection method of 8 macrolide antibiotics including spiramycin and azithromycin in cosmetics. This standard adopts Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) as the main detection equipment, combined with external standard quantitative technology, to provide a set of accurate and efficient detection solutions.

Background and Significance of Standard Formulation

Macrolide antibiotics are widely used in the medical field due to their unique antibacterial effects. However, due to their potential toxicity and threat to human health, my country's "Technical Specifications for Safety of Cosmetics (2015 Edition)" lists them as prohibited substances. The formulation of GB/T 35951-2018 fills the gap in the detection methods of these antibiotics in cosmetics and provides important technical support for ensuring the safety of cosmetics.

Comparison of standard frameworks

Analysis of core testing steps

The standard specifies a detailed testing process, including sample extraction, cleanup and quantitative analysis:

1. Sample extraction:Different extraction methods are used according to the type of cosmetics (oil-in-water or water-in-oil).
2. Solid phase extraction:Use Oasis HLB solid phase extraction column for purification to ensure effective removal of impurities.
3. Liquid chromatography separation:Use C₁₈ column, and the gradient elution conditions are shown in Table 1.
4. Tandem mass spectrometry detection:Multiple reaction monitoring (MRM) was performed in electrospray ionization (ESI) source mode. The mass spectrometry parameters are detailed in Table 2.

Implementation recommendations and precautions

To ensure the accuracy and reliability of the test results, it is recommended that:

• Operate strictly in accordance with the reagent preparation and instrument conditions specified in the standard.
• Regularly calibrate the instrument, especially the key parameters of liquid chromatography-tandem mass spectrometer.
• Pay attention to potential errors in sample preparation, especially in the extraction and cleanup steps.
• For complex samples (such as those containing a lot of matrix interference), additional quality control tests are recommended.

Future prospects of the standard

With the development of the cosmetics industry and the advancement of technology, the detection method of macrolide antibiotics will continue to be optimized. Possible future directions include:

1. Develop more sensitive detection technology to reduce the detection limit.
2. Introduce artificial intelligence algorithms to improve data analysis efficiency.
3. Expand the coverage of standards to include more new antibiotics.