Laboratory products
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ChroZen USP 467 Player is the optimised system for determination of residual solvents by fully complying with USP 467 and verifies the validity of analysis results for each analysis method.
For pharmacopeial purposes, residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. Because these solvents can be harmful to human body if they remain in the final products, it is required to regulate these compounds not to exceed the specific limits defined in certain regulations.
United Stated Pharmacopeia (USP) classifies the residual solvents into Class â… , Class â…¡ and Class â…¢ depending on their risk to human health and USP 467 test method describes all the requirements for the analysis of residual solvents.
In this study, the determination of residual solvents (Class 1 & 2) in pharmaceutical products by ChroZen GC/FID with Headspace was conducted according to the method (Procedure A) specified in USP 467.
All of 5 compounds in Class 1 mixture had the S/N higher than 3 and 1,1,1-trichloroethane’s S/N was higher than 5. Moreover, the resolution of acetonitrile and methylene chloride was 2.48, which proves all are satisfied with the requirements.
YoungIn Chromass provides one stop solution for various dedicated applications and you only need to let us know what to analyse, and then every single component that is required to analyse your sample will be configured right away.
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