GB/T 37626-2019 in English

1. Background and significance of standard formulation

With the rapid development of the cosmetics industry, the detection of banned substances has become an important part of protecting the health of consumers. GB/T 37626-2019 standard has formulated detailed determination methods for 9 banned penicillin antibiotics such as amoxicillin in cosmetics, filling the technical gap in this field in China. Through liquid chromatography-tandem mass spectrometry (LC-MS/MS), effective identification and quantitative analysis of trace impurities are achieved.

2. Detection principle and technical route

Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is used as the core instrument, and the external standard method is used for quantification. The detection process includes sample extraction, purification, volume determination and determination. Penicillin drugs are extracted by alkaline acetonitrile solution, gradient elution is performed after removing the organic solvent, and high-sensitivity detection is achieved by using multiple reaction monitoring mode (MRM).

3. Reagents and instrument requirements

The reagents used in the detection process include high-purity acetonitrile, n-hexane, acetic acid and ammonia water, all of which are first-level water for analytical laboratories (GB/T6682). The main instrument is a liquid chromatography-tandem mass spectrometer (LC-MS/MS), equipped with an electrospray ion source (ESI), which ensures high sensitivity and accuracy.

4. Detailed explanation of the measurement steps

5. Result analysis and recovery rate

The standard curve method was used for quantification, and the content of penicillin antibiotics in the sample was calculated by peak area ratio. The linear range of the method was 10 μg/L to 250 μg/L, and the correlation coefficient was above 0.99. The blank test results showed that the recovery rate of the method was 83.1%~110.5%, and the relative standard deviation was less than 7.10%, which met the precision requirements.

6. Implementation suggestions

• Laboratory conditions:Equipped with LC-MS/MS equipment and professional operators.
• Sample processing: Strictly follow standard procedures for extraction and purification to avoid cross contamination.
• Data recording: Detailed records of measurement parameters and results to ensure data traceability.