China cosmetics clobetasol acetate test method was approved and published by the National Medical Products Administration (NMPA) on October 30, 2023.
Cosmetic products are an integral part of many people’s daily routines, offering various benefits such as skin care, hygiene, and aesthetics. Ensuring the safety and quality of these products is of utmost importance to protect consumers from potential harm. One critical aspect of cosmetics safety is ensuring that cosmetics do not contain any prohibited ingredients. To this end, the NMPA released a standardized testing method for Clobetasol Acetate, a glucocorticoid, which is strictly prohibited in cosmetic formulations in China.
Announcement No. 141/2023 by the NMPA introduces the testing methods for Clobetasol Acetate in cosmetic products. Below you will find a summary of the document:
- Scope: The method applies to a wide range of cosmetic products, including liquids, creams, gels, mud masks, and films, for qualitative and quantitative analysis of Clobetasol Acetate.
- Principle: Samples are extracted using acetonitrile as a solvent, separated through high-performance liquid chromatography, and detected using mass spectrometry. The content is calculated using a standard curve method.
- Reagents and materials: The Announcement lists the necessary reagents, materials, and instruments for the analysis.
- Instruments and equipment:
- High-performance liquid chromatography-triple quadrupole mass spectrometer.
- Analytical balance: sensitivity 0.0001g and 0.00001g.
- Ultrasonic cleaner.
- Vortex mixer
- Centrifuge.
- Sample Storage: Samples should be stored in accordance with the storage conditions indicated on the label.
- Analysis Procedure: Detailed steps for screening, preparing blank matrix extract, preparing standard intermediate solutions, and determining the samples are outlined.
- Detection and Quantification Limits: The detection and quantification limits for Clobetasol Acetate are provided in the Announcement.
Next steps:
The NMPA may test for the presence of Clobetasol Acetate in cosmetic products in China as part of their annual sampling inspection plan or random inspection controls. If a positive result is given, then products must be withdrawn from the market. Please contact your China responsible person for more information.
Further information:
Read the original article on China releases clobetasol acetate test method for cosmetics.
For more information about standards and tests applicable to cosmetics in China, please refer to these recent blog posts:
- Safety and Technical Standards for Cosmetics (STSC) draft update
- The latest official update to the STSC in 2021.
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