Rapid Pharmaceutical Cleaning Validation——DCS-Cell Ambient Ionization Miniature Mass Spectrometry Solution

China is a major producer of active pharmaceutical ingredients. After a laboratory-scale success, many synthetic processes require scale-up evaluation in pilot plants before progressing to the full-scale industrial production stage. These pilot plants often have stringent cleanliness requirements.
To confirm the cleanliness of equipment, residue cleaning validation is necessary. In the pharmaceutical industry, there are two specified methods for detecting residues in current regulations: High-Performance Liquid Chromatography (HPLC, a specific method) and Total Organic Carbon (TOC, a non-specific method). The advantage of HPLC is its specificity for each organic compound, but it has the drawback of being time-consuming, with testing taking several hours, and it can be relatively complex to operate. The sensitivity of HPLC is also limited by its detector. On the other hand, TOC offers the advantage of high sensitivity and simplicity of operation. However, it is non-specific and measures the total organic content, making it unable to provide specific detection for individual pharmaceuticals.
The application is based on the ambient ionization miniature mass spectrometry method for the analysis of common drugs, such as acetaminophen and benorilate. It combines the advantages of the two methods mentioned above, offering targeted detection and high sensitivity for specific organic compounds. Importantly, it eliminates the need for complex post-reaction processing and sample preparation. Additionally, it can provide structural information about the substances. The solution facilitates real-time and rapid completion of cleaning validation in pharmaceutical syntheses.

The application is based on the ambient ionization technique of the Direct Sampling Ionization (DCS) Cartridge and the Cell Miniature Mass Spectrometry System, establishing a real-time and rapid testing method for pharmaceutical cleaning validation. The method offers several advantages, including high specificity, high sensitivity, and ease of operation. There is no need for chromatographic separation, complex post-reaction processing, or sample preparation. The DCS Cartridge, based on ambient ionization technique, is directly used to wipe the interior of a reaction vessel for testing, providing a quick and convenient way to perform cleaning validation. As a result, it offers a fast and straightforward solution for pharmaceutical cleaning validation.